Burzynski: Why has the FDA NOT granted Accelerated Approval for Antineoplastons A10 (Atengenal) and AS2-1 (Astugenal) ?

======================================
1996 – Accelerated approval started by United States Food and Drug Administration Commissioner, Dr. David A. Kessler
(.4:18 – .6:10):
http://www.youtube.com/watch?v=1buiXWr_QTQ
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Tamoxifen:
======================================
7/1997 – A phase I study of high-dose tamoxifen for the treatment of refractory malignant GLIOMAS OF CHILDHOOD
http://www.ncbi.nlm.nih.gov/pubmed/9815790/
Clin Cancer Res. 1997 Jul;3(7):1109-15
http://www.ncbi.nlm.nih.gov/m/pubmed/9815790/
Clin Cancer Res July 1997 3; 1109
http://m.clincancerres.aacrjournals.org/content/3/7/1109.full.pd
Departments of Neurosurgery, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania, USA

http://clincancerres.aacrjournals.org/content/3/7/1109
Children with malignant GLIOMAS THAT PROGRESSED AFTER CONVENTIONAL THERAPY
——————————————————————
0 / 0% – EXHIBITED CLEAR-CUT TUMOR regression
——————————————————————
17 months (1 year 5 months) – longest survivor lived for after beginning tamoxifen
======================================
2000 – Radiation therapy and high-dose tamoxifen in the treatment of patients with diffuse BRAINSTEM GLIOMAS:

results of a Brazilian cooperative study
http://www.ncbi.nlm.nih.gov/pubmed/10715294/
Brainstem Glioma Cooperative Group
http://www.ncbi.nlm.nih.gov/m/pubmed/10715294/
J Clin Oncol 18, 1246-1253
http://m.jco.ascopubs.org/content/18/6/1246.long
——————————————————————
22 – assessable patients
——————————————————————
10.3 months – Median Survival
——————————————————————
4 / 18% – remain alive without tumoral progression
——————————————————————
8 / 37.0% {+/- 2 / 9.5%} (mean +/- SD) – 1-year Survival rate
——————————————————————
treatment combination PRODUCED NO SIGNIFICANT CHANGE in overall POOR prognosis of patients

Most tumors responded initially to treatment but recurred as study progressed

Based on POOR RESULTS, recommend ALTERNATIVE TREATMENTS be tested in patients with this type of tumor
======================================
Temodar (Temozolomide):
======================================
Temozolomide received accelerated approval by the U.S. Food and Drug Administration 1/1999 for treatment of ANAPLASTIC ASTROCYTOMA (brain cancer) patients
——————————————————————
54 patients
——————————————————————
12 / 22% – response rate
——————————————————————
5 / 9% – Complete Response rate
——————————————————————
50 weeks (16-114 weeks) – Median duration of all responses
——————————————————————
64 weeks (52-114 weeks) – Median duration of Complete Response
——————————————————————
4.4 months – Median Progression-Free Survival
——————————————————————
15.9 months (1 year 3.9 months) – Median Overall Survival
——————————————————————
At time of approval, NO RESULTS were available from randomized controlled trials in refractory ANAPLASTIC ASTROCYTOMA that show clinical benefit such as improvement in disease-related symptoms or prolonged survival
——————————————————————
http://clincancerres.aacrjournals.org/content/11/19/6767.full
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Was the United States Food and Drug Administration’s 1/1999 accelerated approval based on the PUBLISHED FINAL RESULTS OF A PHASE II (2) CLINICAL TRIAL?
======================================
12/2000 – Temozolomide and ANAPLASTIC ASTROCYTOMA:

new indication

NO CLEAR PROOF OF EFFICACY
http://www.ncbi.nlm.nih.gov/pubmed/11475493/
Prescrire Int. 2000 Dec;9(50):170-1.
http://www.ncbi.nlm.nih.gov/m/pubmed/11475493/
(1) Temozolomide recently licensed in France for treating patients with ANAPLASTIC ASTROCYTOMA who are in relapse or progression after standard therapy
——————————————————————
(2) clinical dossier contains only one non comparative trial
——————————————————————
(3) 111 patients with ANAPLASTIC ASTROCYTOMA or oligoanaplastic astrocytoma had not all had the standard treatment with surgery, radiotherapy and chemotherapy
——————————————————————
54 patients – subgroup who met criteria
——————————————————————
16 months (1 year 4 months) – Median Global Survival
——————————————————————
31 months (2 years 7 months) – Median Global Survival from start of initial treatment
——————————————————————
NO BETTER THAN SURVIVAL BEFORE THE INTRODUCTION OF temozolomide
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The answer is: NO

1/1999 – FDA Accelerated Approval
9/1999 – Phase 2 publication
======================================
9/1999 – Multicenter phase II trial of temozolomide in patients with ANAPLASTIC ASTROCYTOMA or anaplastic oligoastrocytoma at first relapse

Temodal Brain Tumor Group
http://www.ncbi.nlm.nih.gov/pubmed/10561351/
J Clin Oncol. 1999 Sep;17(9):2762-71.
http://www.ncbi.nlm.nih.gov/m/pubmed/10561351/
University of Texas M.D. Anderson Cancer Center, Houston, TX, USA
======================================
http://www.drugs.com/pro/temodar.html
======================================
http://www.pharmainfo.net/fda-articles/fda-safety-page-fatal-medication-errors-associated-temodar
======================================
TEMODAR ADVERSE EVENTS REPORTED TO THE FDA OVER TIME:
http://www.drugcite.com/?q=TEMODAR
======================================
ADVERSE EVENTS:
Primary Suspect Reports: 4,436
Total Reports: 6,350
http://www.adverseevents.com/drugdetail.php?AEDrugID=1794&BrandName=TEMODAR
======================================
http://www.temodar.com/temodar/index.do
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2004 – Supratentorial high-grade ASTROCYTOMA and DIFFUSE BRAINSTEM GLIOMA:

two challenges for the pediatric oncologist
http://www.ncbi.nlm.nih.gov/pubmed/15047924/
Oncologist. 2004;9(2):197-206.
http://www.ncbi.nlm.nih.gov/m/pubmed/15047924/
Oncologist 9, 197-206
http://m.theoncologist.alphamedpress.org/content/9/2/197.long
Division of Neuro-Oncology, Department of Hematology-Oncology, St. Jude Children’s Research Hospital, Memphis, Tennessee, USA

neoplasms predominantly involve supratentorial hemispheres or pons, in which case tumors are usually called DIFFUSE BRAINSTEM GLIOMAS

supratentorial neoplasms
——————————————————————
diagnosis of DIFFUSE BRAINSTEM GLIOMA based upon typical imaging, dispensing with need for surgery in majority of cases

Radiation therapy is mainstay of treatment for children with DIFFUSE BRAINSTEM GLIOMAS
——————————————————————
2 years – Less than 10% of children with diffuse brainstem gliomas survive
——————————————————————
outcome for patients with either type of tumor is POOR when standard multimodality therapy is used

children are ideal candidates for INNOVATIVE TREATMENT approaches
——————————————————————
3-21 years Patients were eligible for current multiinstitutional study
——————————————————————
33 patients (6.4 years – Median age at diagnosis) enrolled
——————————————————————
33 / 100% – DIED OF DISEASE PROGRESSION
——————————————————————
12 months (1 year) – Median Survival
——————————————————————
16 / 48% – estimated 1-year Survival rate (standard error, 1 / 8%)
——————————————————————
administration of temozolomide after RT DIDN’T ALTER POOR PROGNOSIS associated with newly diagnosed diffuse BRAINSTEM GLIOMA in children
======================================
1/1/2005 (11/24/2004) – Role of temozolomide after radiotherapy for newly diagnosed diffuse BRAINSTEM GLIOMA in children:

results of a multiinstitutional study (SJHG-98)
http://www.ncbi.nlm.nih.gov/pubmed/15565574
Cancer. 2005 Jan 1;103(1):133-9.
http://www.ncbi.nlm.nih.gov/m/pubmed/15565574
Cancer 103, 133-139
http://onlinelibrary.wiley.com/doi/10.1002/cncr.20741/abstract;jsessionid=6717837591CCC8FCBD8E46163808E221.d03t01
Cancer
Volume 103, Issue 1, pages 133–139, 1 January 2005
http://onlinelibrary.wiley.com/doi/10.1002/cncr.20741/full
Article first published online: 24 NOV 2004
References:
http://onlinelibrary.wiley.com/doi/10.1002/cncr.20741/references
Cited By:
http://onlinelibrary.wiley.com/doi/10.1002/cncr.20741/citedby
DOI: 10.1002/cncr.20741

Department of Hematology-Oncology, St. Jude Children’s Research Hospital, Memphis, Tennessee, USA
——————————————————————
33 patients: (33 / 100% – 6.4 years: Median age)
——————————————————————
33 / 100% – ALL DIED OF DISEASE PROGRESSION
——————————————————————
12 months (1 year) – Median Survival
——————————————————————
16 / 48% – 1 year estimated Survival rate
——————————————————————
Table 1. Results of radiation therapy in combination with chemotherapy for newly diagnosed, diffuse, intrinsic BRAIN STEM GLIOMA

Author
Study Type
Patients Total No.
Treatment Radiation Therapy
Additional Chemotherapy
Efficacy
OS MST CR PR SD PD

Multiinstitutional 33 56 Temozolomide, irinotecan 0 0 12 NA NA NA

response rates based on evaluable patients
32 54 Topotecan

CR – complete response
GCSF – granulocyte colony stimulating factor
HD – high dose tamoxifen
HDB – high dose chemotherapy and autologous bone marrow transplantation HF – hyperfractionated
M – months
MST – median survival time
NA – not available
OS – overall survival
PD – progressive disease
PR – partial response
SD – stable disease
UNK – unknown
* 1 patient had radiological improvement

Cancer 103, 133-139
——————————————————————
3-21 years – eligible for current multiinstitutional study
——————————————————————
33 – (Median age at diagnosis
6.4 years) enrolled
——————————————————————
ALL PATIENTS DIED OF DISEASE PROGRESSION
——————————————————————
12 months (1 year) – Median Survival
——————————————————————
48% – estimated 1-year Survival rate (standard error 8%)
——————————————————————
administration of temozolomide after RT DIDN’T ALTER POOR PROGNOSIS associated with newly diagnosed diffuse BRAINSTEM GLIOMA in children
======================================
2/2008 (2/2/2007)
Treatment of children with diffuse intrinsic BRAIN STEM GLIOMA
with radiotherapy, vincristine and oral VP-16:

a Children’s Oncology Group phase II study
http://www.ncbi.nlm.nih.gov/pubmed/17278121
Pediatr Blood Cancer. 2008 Feb;50(2):227-30
http://www.ncbi.nlm.nih.gov/m/pubmed/17278121
University of Rochester Medical Center, Rochester, New York, USA.

http://onlinelibrary.wiley.com/doi/10.1002/pbc.21154/abstract;jsessionid=DE7A67EFBAC1A184F6805F11CFC4F30B.d02t02
Article first published online: 2 FEB 2007
DOI: 10.1002/pbc.21154

prognosis for children with BRAIN STEM GLIOMA remains grim

The Pediatric Oncology Group (POG, now part of Children’s Oncology Group) conducted study using agents in combination with standard external beam radiation for children with newly diagnosed BRAIN STEM GLIOMA
——————————————————————
Children eligible
3-21 years of age, had MRI-evidence of diffuse intrinsic pontine glioma, and had neurologic deficits of <6 months duration
——————————————————————
30 eligible and evaluable for Survival / toxicity
——————————————————————
8 years (3-14 years) – Median age
——————————————————————
7 / 23% – Partial Response following radiation
18 / 60% – Stable Disease
2 / 7% – Progressive Disease
3 / 10% – Response Not measured
——————————————————————
30 / 100% CHILDREN DIED
——————————————————————
Overall Survival 1 year
27 +/- 7%
2 years, 3 +/- 2%
——————————————————————
9 months (3-36 months) – Median Survival
——————————————————————
addition of vincristine and oral VP-16 to standard external beam radiation causes moderate toxicity and DOESN’T IMPROVE SURVIVAL OF CHILDREN WITH DIFFUSE INTRINSIC BRAIN STEM GLIOMA
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Avastin (Bevacizumab):
======================================
5/6/2009 – U.S. Food and Drug Administration (FDA) granted accelerated approval of Avastin (bevacizumab) for people with GLIOBLASTOMA (brain cancer) with progressive disease following prior therapy

effectiveness of Avastin in AGGRESSIVE form of BRAIN CANCER based on improvement in objective response rate

Currently, NO DATA available from randomized controlled trials demonstrating improvement in disease-related symptoms or increased survival with Avastin in GLIOBLASTOMA
——————————————————————
11.3 months – Progression-Free Survival
——————————————————————
http://www.drugs.com/newdrugs/fda-grants-accelerated-approval-avastin-combination-paclitaxel-chemotherapy-first-line-advanced-852.html
According to FDA analysis of study

Study AVF3708g
——————————————————————
22 / 26% – tumor responses observed of 85 patients treated with Avastin alone
——————————————————————
4.2 months – Median duration of response in patients
——————————————————————
Study NCI 06-C-0064E

Efficacy of Avastin in GLIOBLASTOMA that progressed following prior therapy supported by another study that used same response assessment criteria as AVF3708g

56 patients treated with Avastin alone
——————————————————————
11 / 20% of patients – Responses were observed
——————————————————————
3.9 months – Median duration of response
——————————————————————
http://www.cancer.gov/cancertopics/druginfo/fda-bevacizumab
FDA – “People with this type of brain cancer have had no new treatments in more than a decade”
http://www.drugs.com/newdrugs/fda-grants-accelerated-approval-avastin-brain-cancer-glioblastoma-has-progressed-following-prior-1342.html
——————————————————————
Avastin is gene-targeted therapy, which can only target certain specific genes
======================================
Afinitor (Everolimus):
======================================
Afinitor (ubependymal giant cell ASTROCYTOMA (SEGA) brain tumor)
——————————————————————
10/29/2010 – FDA granted accelerated approval for Afinitor after single Phase 2 study of only 28 patients
——————————————————————
32% experienced 50% reduction of tumor
——————————————————————
none of their tumors went away completely
======================================
Was the United States Food and Drug Administration’s 10/29/2010 accelerated approval based on the PUBLISHED FINAL RESULTS OF A PHASE II (2) CLINICAL TRIAL?
======================================
10/12/2011 (8/1/2011) – Everolimus tablets for patients with subependymal giant cell ASTROCYTOMA
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3389821/
Expert Opin Pharmacother. Author manuscript; available in PMC 2012 July 5.
Published in final edited form as:
Expert Opin Pharmacother. 2011 October; 12(14): 2265–2269.
Published online 2011 August 1. doi: 10.1517/14656566.2011.601742
PMCID: PMC3389821
NIHMSID: NIHMS385824
——————————————————————
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm231967.htm
======================================
The answer is: NO

10/29/2010 – FDA Accelerated Approval
10/12/2011 – publication
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ
COMPARE COMBINED:
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ
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ANAPLASTIC ASTROCYTOMA
==========================
22% – Objective Response: Objective response = complete response and partial response – Antineoplastons
ᅵ
22% – response rate: Temodar
——————————————————————
11% – Complete Response: Antineoplastons
ᅵ
9% – Complete Response rate: Temodar
——————————————————————
17+ years – Maximum Survival : patient with ANAPLASTIC ASTROCYTOMA – Antineoplastons
ᅵ
50 weeks (16-114 weeks) – Median duration of all responses: Temodar
——————————————————————
17+ years – Maximum Survival : patient with ANAPLASTIC ASTROCYTOMA – Antineoplastons
ᅵ
64 weeks (52-114 weeks) – Median duration of Complete Response: Temodar
——————————————————————
6 months – 7 / 39% Progression-Free Survival: Antineoplastons
ᅵ
4.4 months – Median Progression-Free Survival: Temodar
——————————————————————
5 years – 4 / 22% Overall Survival: Antineoplastons
ᅵ
2 years – 7 / 39% Overall Survival: Antineoplastons
ᅵ
2 years – Most patients with brainstem glioma fail standard radiation therapy and chemotherapy and do not survive longer
ᅵ
15.9 months (1 year 3.9 months) – Median Overall Survival: Temodar
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ
COMPARE COMBINED:
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ
======================================
GLIOBLASTOMA
======================================
39% – Progression-Free Survival (PFS) at 6 months: Antineoplastons
ᅵ
5.28 months – Median Progression-Free Survival (PFS): Antineoplastons
ᅵ
11.3 months – Progression-Free Survival: Avastin
——————————————————————
32% – % of Patients Showing Objective Response = complete response and partial response: Antineoplastons
ᅵ
26% – tumor responses observed Avastin
——————————————————————
42% – special exception (SE): Overall survival (OS) – 2 years: Antineoplastons
ᅵ
36% – BT-11: Overall survival (OS) – 2 years: Antineoplastons
ᅵ
19% – special exception (SE): Overall survival (OS) – 5 years: Antineoplastons
ᅵ
25% – BT-11: Overall survival (OS) – 5 years: Antineoplastons
ᅵ
4.2 months – Median duration of response in patients: Avastin
——————————————————————
9 / 32% – # and % of Patients Showing Objective response = complete response and partial response – Antineoplastons
ᅵ
11 / 20% of patients – Responses were observed: Avastin
——————————————————————
5+ years – Maximum Survival : patient with GLIOBLASTOMA – Antineoplastons
ᅵ
3.9 months – Median duration of response: Avastin
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ
COMPARE COMBINED:
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ
======================================
ASTROCYTOMA
======================================
47% / 7 – % and # of Patients Showing Objective response = complete response (6) and partial response (1) – Antineoplastons
ᅵ
32% experienced 50% reduction of tumor – Afinitor
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ
Burzynski: Complete Response, Partial Response, Stable Disease, Progressive Disease, Objective Response, and Response:
https://stanislawrajmundburzynski.wordpress.com/2013/07/04/burzynski-complete-response-partial-response-stable-disease-progressive-disease-objective-response-and-response/
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ
Burzynski: Progression-Free Survival:
https://stanislawrajmundburzynski.wordpress.com/2013/07/04/burzynski-progression-free-survival/
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ
WHAT IS MISDIRECTION ? Critiquing “Antineoplastons: Has the FDA kept its promise to the American people ?”:
https://stanislawrajmundburzynski.wordpress.com/2013/06/08/what-is-misdirection-critiquing-antineoplastons-has-the-fda-kept-its-promise-to-the-american-people/
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ

Critiquing: In which Orac does Stanislaw Burzynski propagandist Eric Merola a favor


“Orac” / Dr. David H. Gorski posted his lame 6/3/2013 excuse for a review of Burzynski: Cancer Is Serious Business, Part II (2), and I critiqued it:

Critiquing: In which the latest movie about Stanislaw Burzynski “cancer cure” is reviewed
with Insolence:
https://stanislawrajmundburzynski.wordpress.com/2013/07/18/critiquing-in-which-the-latest-movie-about-stanislaw-burzynski-cancer-cure-is-reviewed-with-insolence-2/
7/17/2013 Gorski pushed out his “best” effort:

In which Orac does Stanislaw Burzynski propagandist Eric Merola a favor

http://scienceblogs.com/insolence/2013/07/17/in-which-orac-does-stanislaw-burzynski-propagandist-eric-merola-a-favor/
After my Epic Sharknado Deconstruction of “Orac’s” “review,” I thought it only fair to continue the feeding frenzy with a Burzynski Texas Tornado

Believe it or not, I’m going to do “Dr.” Gorski (who particularly likes me, to the point of thinking, apparently, that I’m a white research supremacist) a favor

“Dr.” Gorski, as you recall, is a supposed “Doctor,” oncologist, breast cancer specialist, cancer (cough-cough) “researcher” who was responsible for two dubious propaganda reviews about documentary films which Eric Merola made re: Stanislaw Burzynski, the cancer doctor who has used “antineoplastons” to treat cancer without having published any final clinical trial evidence that they do what he claims, since his 1st completed phase II (2) clinical trial in 2009

However, no worries

M. D. Anderson did a clinical trial in 2006 and did NOT publish the final results until 6-7 years later, 2/13/2013

Based on that criteria, Burzynski has until 2016-2017 to publish

Back in 2010, Merola released the first of a dynamic duo of films, the first of which was called Burzynski The Movie: Cancer Is A Serious Business (as Gorski likes to call it, by adding an “A” in the title)

The sequel, the slightly less pretentiously titled Burzynski: Cancer Is A Serious Business, Part 2 (as Gorski again likes to call it with the “A”), was then released June 1 on various pay-per-view modes

As has been pointed out, it’s better than the first, and it features direct attacks on The Skeptics™, or SkeptiCowards©, if you will, who had the temerity to criticize Burzynski and Merola over the last couple of years with their school-yard bully attacks, NOT having the intestinal testicular fortitude to back up their claims with any citation(s), reference(s), and / or link(s) in support of their blatherskite, which they found worthy enough to defend on my blog

Merola is apparently trying to recreate the success of his previous strategy, which involved letting people watch the movie online for free for limited periods of time on websites like Mercola.com

I link directly to the Mercola.com link to the second Burzynski movie, because I want to give Mercola more Google juice than he already has

The movie was, however, on Vimeo until July 20:

BURZYNSKI: CANCER IS SERIOUS BUSINESS, PART II (2013) from BurzynskiMovie on Vimeo
http://articles.mercola.com/sites/articles/archive/2013/07/13/burzynski-cancer-film.aspx
If you want to see what the fuss was about and whether my criticisms of The Skeptics™, or SkeptiCowards©, were valid, now’s your chance

If you want to see the highlighted attack on The Skeptics™ SkeptiCowards©, it begins around 1:19 h into the movie

Yes, I’m encouraging you to watch Burzynski 2

It’s a beautiful example of all the things that Gorski tried to inculcate #TAM2013 attendees against

Indeed, dissecting this magnum opus is an excellent way to teach oneself critical thinking, much as dissecting creationist tripe is

Unfortunately, Gorski is unable to do this, because individuals like me, exist and will NOT let him get away with his disingenuous hack attacks

Other key points include:

Laura Hymas interview and the recording of her discussion with her oncologist (approximately 0:28 h in)

This section is horrifying (to Gorski, at least) to watch, as he can’t help but feel how dicey and ethical the situation that poor UK NHS oncologist found himself in with Hymas and her family demanding that he help her be part of one of Burzynski’s “clinical trials” by agreeing to be the local physician and agreeing to order various scans

The end of the story of Amelia Saunders (approximately 0:58 h in)

This is one where Merola caused Gorski true revulsion, as he basically implied that Amelia died because her parents took her off the antineoplastons

Or you can read what Eric Merola REALLY posted on Twitter:
https://stanislawrajmundburzynski.wordpress.com/2013/04/18/fact-checking-httpthehoustoncancerquack-com/
Hideaki Tsuda’s clinical trial (approximately 1:31 h in)

Gorski wonders why he hasn’t yet published, just like he wonders why Burzynski hasn’t published, but Gorski, SkeptiCoward© that he is, can NOT seem to explain why The Lancet Oncology Peer Review Team D-12-01519 refused to publish Burzynski’s 11/26/2012 (1:29:53) phase 2 clinical trial Progression-Free Survival (PFS) and Overall Survival (OS) re patients 8 – 16 years after diagnosis, results

Those of you who watch it, let Gorski know what you think

Those of you who can only watch part of it, let Gorski know what you think of that section

Remember, though, Gorski will BLOCK you if you question HIS infallibility, because he and his “Oracolytes” would rather comment on things that have NOTHING WHATSOEVER to do with Burzynski, like:

“it is possible to link without boosting google rankings through the “no-follow command”: http://en.wikipedia.org/wiki/Nofollow I learned about this from Bob Blaskiewicz, who proposed that we use this when linking to dubious websites in our posts”

Gorski makes unreliable excuses for NOT doing research re Burzynski, so I did it for him

Burzynski: Complete Response, Partial Response, Stable Disease, Progressive Disease, Objective Response, and Response:
https://stanislawrajmundburzynski.wordpress.com/2013/07/04/burzynski-complete-response-partial-response-stable-disease-progressive-disease-objective-response-and-response/
Burzynski: Progression-Free Survival (PFS):
https://stanislawrajmundburzynski.wordpress.com/2013/07/04/burzynski-progression-free-survival/
Antineoplastons: Adverse Effects:
https://stanislawrajmundburzynski.wordpress.com/2013/07/02/antineoplastons-adverse-effects/
Burzynski: Acknowledgements, Authors, and Co-Investigators:
https://stanislawrajmundburzynski.wordpress.com/2013/07/03/burzynski-acknowledgements/
Burzynski: Institutional Review Board (IRB):
https://stanislawrajmundburzynski.wordpress.com/2013/07/02/burzynski-institutional-review-board-irb/
And because Gorski and others do NOT seem to understand how antineoplastons (ANP) A10 (Atengenal) and AS2-1 (Astugenal) work, I provide the relevant Burzynski publications and page #’s for them to review:
http://www.burzynskiclinic.com/scientific-publications.html
======================================
Interim Reports on Clinial Trials
16. 2003 (BT-11)
Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic brain stem glioma: a preliminary report.
DRUGS IN R&D
http://www.ncbi.nlm.nih.gov/pubmed/12718563
Drugs in R and D
http://www.ncbi.nlm.nih.gov/m/pubmed/12718563
(Drugs in Research and Development)
http://www.burzynskiclinic.com/images/stories/Publications/960.pdf
Drugs R D. 2003;4(2):91-101
Drugs in R&D 2003;4:91-101
ᅵ
Pg. 92
Antineoplaston A10 and AS2-1 are synthetic derivatives of phenylacetate (PN) acid, glutamine and isoglutamine
ᅵ
A10 is sterile solution of sodium phenylacetylisoglutiminate (isoPG) in 4 : 1 ratio
ᅵ
Antineoplaston AS2-1 is sterile solution of sodium phenylacetate (PN) and phenylacetylglutaminate (PG) in 4 : 1 ratio
ᅵ
Pg. 97
Discussion
Pg. 99

======================================
Review Articles on Clinical Trials:
1. 3/2004
The Present State of Antineoplaston Research
http://www.burzynskiclinic.com/images/stories/Publications/994.pdf
Integrative Cancer Therapies 2004;3:47-58
Volume 3, No. 1, March 2004
DOI: 10.1177/1534735-403261964
Volume 3 Number 1 March 2004
ᅵ
Pg. 47
Pg. 48
Mechanism of Action of Antineoplaston
Pg. 49
Pg. 50
ᅵ
The reason for 50% Progressive Disease (PD) in studies is long dose-escalation process, which extends to more than a month’s time period, before the optimal dosage is reached
ᅵ
Pg. 56
Conclusion

======================================
Case Reports:
4. 9/2004 (Special Exception (SE) to BT-11 Study (ST))
Long-term survival and complete response of a patient with recurrent diffuse intrinsic brain stem glioblastoma multiforme
http://www.burzynskiclinic.com/images/stories/Publications/1145.pdf
Integrative Cancer Therapies 2004;3:257-261
Volume 3, Number 3 September 2004
DOI: 10.1177/1534735404267748
ᅵ
Pgs. 257-258
Pg. 260
Discussion
Pg. 261

======================================
Interim Reports on Clinial Trials:
2. 10/2004
Phase II study of Antineoplastons A10 and AS2-1 (ANP) in recurrent glioblastoma multiforme
http://www.burzynskiclinic.com/images/stories/Publications/1218.pdf
Neuro-Oncology. 2004; 6: 384
Volume 6 Issue 4 October 2004
Abstracts from the Society for Neuro-Oncology Ninth Annual Meeting, Toronto, Ontario, Canada, November 18-21, 2004
ᅵ
Pg. 385
======================================
Interim Reports on Clinial Trials:
3. 10/2004 (Study (ST) and Special Exception (SE))
Long-term survivals in phase II studies of Antineoplastons A10 and AS2-1 (ANP) in patients with diffuse intrinsic brain stem glioma
http://www.burzynskiclinic.com/images/stories/Publications/1219.pdf
Neuro-Oncology. 2004; 6: 386
Volume 6 Issue 4 October 2004
ᅵ
Antineoplastons (ANP) consist of 3 active ingredients including sodium salts of phenylacetylglutamine (PG), phenylacetylisoglutimine (isoPG), and phenylacetic acid (PN)
ᅵ
Preclinical data supports that the mechanism of antineoplastic activity in DBSG, involves interruption of signal transmission in the RAS, (PN) AKT2, and TGFB1 (PG) pathways, activation of p53 and p21 tumor suppressor genes (PN) and apoptosis (PG and isoPG)

======================================
Interim Reports on Clinial Trials:
17. 2004 (BT-13 and BT-23)
Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive multicentric glioma :
a preliminary report
DRUGS IN R&D
http://www.ncbi.nlm.nih.gov/pubmed/15563234
Drugs in R and D
http://www.ncbi.nlm.nih.gov/m/pubmed/15563234
(Drugs in Research and Development)
http://www.burzynskiclinic.com/images/stories/Publications/1194.pdf
Drugs R D. 2004;5(6):315-26
Drugs R&D 2004;5(6):315-326.
ᅵ
Pg. 316
Pg. 324
Discussion

======================================
Interim Reports on Clinial Trials:
18. 6/2005 (CAN-01 and BT-12)
Burzynski, S.R., Weaver, R.A., Janicki, T., Szymkowski, B., Jurida, G., Khan, M., Dolgopolov, V.
Long-term survival of high-risk pediatric patients with primitive neuroectodermal tumors treated with Antineoplastons A10 and AS2-1
http://www.ncbi.nlm.nih.gov/pubmed/15911929
Integr Cancer Ther. 2005 Jun;4(2):168-77
http://www.ncbi.nlm.nih.gov/m/pubmed/15911929
Integrative Cancer Therapies 2005;4(2):168-177
http://www.burzynskiclinic.com/images/stories/Publications/1220.pdf
DOI: 10.1177/1534735405276835
http://m.ict.sagepub.com/content/4/2/168.long?view=long&pmid=15911929
Volume 4 Number 2 June 2005
ᅵ
Pg. 168
Pg. 174
Discussion
Pgs. 175-176

======================================
Interim Reports on Clinial Trials:
19. 3/2006 (BT-03, BT-11, BT-18, and CAN-01)
Targeted therapy with Antineoplastons A10 and AS2-1 of high grade, recurrent, and progressive brainstem glioma.
http://www.ncbi.nlm.nih.gov/pubmed/16484713
Integr Cancer Ther. 2006 Mar;5(1):40-7
http://www.ncbi.nlm.nih.gov/m/pubmed/16484713
Integrative Cancer Therapies 2006;5(1):40-47
http://www.burzynskiclinic.com/images/stories/Publications/5825.pdf
DOI: 10.1177/1534735405285380
http://m.ict.sagepub.com/content/5/1/40.long?view=long&pmid=16484713
ᅵ
Pgs. 40-41
Pg. 46
Discussion
Conclusion

======================================
Interim Reports on Clinial Trials:
8. 10/2006
Treatment of multicentric brainstem gliomas with antineoplastons (ANP) A10 and AS2-1.
http://www.burzynskiclinic.com/images/stories/Publications/2105.pdf
Neuro-Oncology. 2006; 8:466.
Volume 8 Issue 4 October 2006
Abstracts for the Eleventh Annual Meeting of the Society for Neuro-Oncology (SNO)
ᅵ
Pg. 466
Antineoplastons (ANP) are synthetic analogues of naturally occurring phenylacetylglutamine (PG), phenylacetylisoglutimine (isoPG), and phenylacetate (PN)

======================================
Review Articles on Clinical Trials:
3. 12/2007
Recent clinical trials in diffuse intrinsic brainstem glioma. Cancer Therapy 2007; 5, 379-390.
http://www.burzynskiclinic.com/images/stories/Publications/5692.pdf
Review Article
Cancer Therapy Vol 5, 379-390, 2007
http://www.cancer-therapy.org/CT/v5/B/HTML/42._Burzynski,_379-390.html
Volume 5 Number 2 December, 2007
ᅵ
Pg. 381
Pg. 384
E. Multitargeted therapy

======================================
Interim Reports on Clinical Trials:
11. 10/2008
(BT-8 – PATIENTS WITH ANAPLASTIC ASTROCYTOMA)
(BT-15 – ADULT PATIENTS WITH ANAPLASTIC ASTROCYTOMA)
Phase II study of antineoplastons A10 and AS2-1 (ANP) in patients with newly diagnosed anaplastic astrocytoma:
A preliminary report
http://www.burzynskiclinic.com/images/stories/Publications/7853.pdf
Volume 10 Issue 5 October 2008
Neuro-Oncology 2008; 10:821
Abstracts for the Thirteenth Annual Meeting of the Society for Neuro-Oncology, November 20-23, 2008
ᅵ
Pg. 821
ᅵ
Antineoplastons (ANP) are synthetic analogs of naturally occurring phenylacetylglutamine (PG), phenylacetylisoglutimine (isoPG), and phenylacetate (PN)
ᅵ
Antineoplastons (ANP) is a multi-targeted therapy affecting signal transduction, the cell cycle, the TCA cycle, and apoptosis

======================================
Interim Reports on Clinical Trials:
12. 12/2008
(BT-8 – PATIENTS WITH ANAPLASTIC ASTROCYTOMA)
(BT-15 – ADULT PATIENTS WITH ANAPLASTIC ASTROCYTOMA)
Phase II study of antineoplastons A10 and AS2-1 infusions (ANP) in patients with recurrent anaplastic astrocytoma
http://www.burzynskiclinic.com/images/stories/Publications/7898.pdf
Neuro-Oncology 2008; 10:1067
Volume 10 Issue 6 December 2008
Abstracts for the Eighth Congress of the European Association for Neuro-Oncology (EANO), Sept. 12-14, 2008, Barcelona, Spain
ᅵ
Antineoplastons (ANP) affects multiple targets, and its components have different mechanisms of action
ᅵ
A10 interferes with signaling in the AKT2 and MYCC pathways, blocks expression of TGFB1, activates the PTEN and MAD tumor suppressor genes, and normalizes nuclear transport by decreasing the expression of RANBP1, which may restore the activity of the mutated INI protein
ᅵ
AS2-1 interferes with signal transmission in the RAS and BCL2 pathways and activates expression of the tumor suppressors TP53 and p21

======================================
Case Reports:
1. 12/2009 (BT-11 Special Exception (SE))
Over a 10-year survival and complete response of a patient with diffuse intrinsic brainstem glioma (DBSG) treated with antineoplastons (ANP).
http://www.burzynskiclinic.com/images/stories/Publications/8638.pdf
Neuro-Oncology 2009; 11:923.
Volume 11 Issue 6 December 2009
Abstracts from the Third Quadrennial Meeting of the World Federation of Neuro-Oncology (WFNO) and the Sixth Meeting of the Asian Society for Neuro-Oncology (ASNO), May 11-14, 2009, Yokohama, Japan
ᅵ
Antineoplastons (ANP) is a multi-targeted therapy that is well tolerated with minimal and reversible adverse events and has multiple different mechanisms of action by affecting the AKT, RAS, TP53, p21, and PTEN pathways
======================================

Burzynski: Complete Response, Partial Response, Stable Disease, Progressive Disease, Objective Response, and Response

http://www.burzynskiclinic.com/scientific-publications.html
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ
Interim Reports on Clinial Trials:
ᅵ
1. 10/2003
ᅵ
NEURO-ONCOLOGY
ᅵ
Phase II study of Antineoplastons A10 and AS2-1 (ANP) in children with recurrent and progressive MULTICENTRIC GLIOMA
ᅵ
A preliminary report
http://www.burzynskiclinic.com/images/stories/Publications/970.pdf
Neuro-Oncology. 2003; 5: 358
Volume 5 Issue 4 October 2003
ᅵ
Patients had 2 to 7 tumors:
11 – bilateral tumors
7 – visual pathway gliomas with involvement of the optic chiasm
5 – low-grade astrocytoma
4 – involvement of the brain stem
4 – involvement of the spinal cord
2 – leptomeningeal spread
ᅵ
10/2003 – Protocol – MULTICENTRIC GLIOMA
ᅵ
12 – Children Patients Accrued
10 – Evaluable Patients
(9 months – 17 years / 9 – median age)
ᅵ
4 / 33% – # and % of Patients Showing Complete Response
2 / 25% – # and % of Patients Showing Partial Response
4 / 33% – # and % of Patients Showing Stable Disease
0 / 0% – # and % of Patients Showing Progressive Disease
1 / 9% – # and % of Patients Nonevaluable due to only 4 weeks of treatment / lack of follow-up scans. Patient died while on treatment due to brain infarct / counted as treatment failure
6 / 58% – # and % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
ᅵ
1 / 9% – had stable disease discontinued treatment after SD against medical advice and died 4.5 years later
ᅵ
The study continues with accrual of additional patients
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ
Interim Reports on Clinial Trials:
ᅵ
16. 2003
ᅵ
DRUGS IN R&D
Drugs in R and D
(Drugs in Research and Development)
ᅵ
BT-11 – BRAIN STEM GLIOMA
ᅵ
Special exception (SE) to BT-11
ᅵ
Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA:
ᅵ
a preliminary report.
http://www.ncbi.nlm.nih.gov/pubmed/12718563
Drugs R D. 2003;4(2):91-101
http://www.ncbi.nlm.nih.gov/m/pubmed/12718563
Drugs in R&D 2003;4:91-101
http://www.burzynskiclinic.com/images/stories/Publications/960.pdf
Pg. 95
ᅵ
10 / 83% – brain stem glioma
1 / 8% – astrocytoma
1 / 8% – glioma of brain stem and thalamus
ᅵ
Pgs. 91 and 95
ᅵ
3/1996 – Protocol – recurrent diffuse intrinsic BRAIN STEM GLIOMA (3/1996 – 5/1999 enrolled / Pg. 94)
ᅵ
12 – Patients Accrued (Pgs. 91 – 92)
(6 males / 6 females – Pg. 95)
10 – Evaluable Patients (Pg. 91)
(4 – 29 years / 10 – median age: Pg. 95)
ᅵ
2 / 20% – # and % of Patients Showing Complete Response
3 / 30% – # and % of Patients Showing Partial Response
3 / 30% – # and % of Patients Showing Stable Disease
2 / 20% – # and % of Patients Showing Progressive Disease
5 / 50% – # and % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
——————————————————————
Pg. 100
ᅵ
3/1996 – Protocol – recurrent diffuse intrinsic BRAIN STEM GLIOMA
ᅵ
11 – Patients Accrued
11 – Evaluable Patients
(treated under special exception (SE) to BT-11 – Pg. 99)
ᅵ
1 / 9% – # and % of Patients Showing Complete Response
5 / 55% – # and % of Patients Showing Stable Disease
4 / 36% – # and % of Patients Showing Progressive Disease
1 / 9% – # and % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
======================================
COMBINED:
——————————————————————
# and % of Patients Showing Complete Response
2 / 20%
1 / 9% – special exception (SE) to BT-11
——————————————————————
# and % of Patients Showing Partial Response
3 / 30%
——————————————————————
# and % of Patients Showing Stable Disease
3 / 30%
5 / 55% – special exception (SE) to BT-11
——————————————————————
# and % of Patients Showing Progressive Disease
2 / 20%
4 / 36% – special exception (SE) to BT-11
——————————————————————
# and % of Patients Showing Objective Response
5 / 50%
1 / 9% – special exception (SE) to BT-11
ᅵ
Objective response = complete response and partial response
——————————————————————
Pg. 92
ᅵ
Owing to the long accrual process of all 40 patients necessary to complete the study, we decided to report the results of treatment of the 1st 12 patients diagnosed with recurrent diffuse intrinsic BRAIN STEM GLIOMA before completion of the study
ᅵ
Pgs. 91 and 100
ᅵ
Study continues with accrual of additional patients
ᅵ
Pg. 94
ᅵ
In all cases the responses were confirmed by radiologists not affiliated with Burzynski Clinic
ᅵ
All films of patients who obtained Complete Response (CR) and Partial Response (PR) were evaluated by radiologists and oncologists of the FDA
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ
Case Reports:
ᅵ
4. 9/2004
ᅵ
INTEGRATIVE CANCER THERAPIES
ᅵ
Special exception (SE) to BT-11 – BRAIN STEM GLIOMA
ᅵ
Long-term survival and complete response of a patient with recurrent diffuse intrinsic brain stem GLIOBLASTOMA MULTIFORME
http://www.burzynskiclinic.com/images/stories/Publications/1145.pdf
Integrative Cancer Therapies 2004;3:257-261
Volume 3, Number 3 September 2004
DOI: 10.1177/1534735404267748
ᅵ
Pg. 257
ᅵ
2004 – Protocol – recurrent diffuse intrinsic BRAIN STEM GLIOMAs [5]
ᅵ
12 – Patients Accrued
10 – Evaluable Patients
ᅵ
5 / 50% – # and % of Patients Showing Objective Response
3 / 30% – # and % of Patients Showing Stable Disease
2 / 20% – # and % of Patients Showing Progressive Disease who subsequently died
ᅵ
Objective response = complete response and partial response
ᅵ
Pg. 261
ᅵ
5. Burzynski SR, Lewy RI, Weaver RA, et al. Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA (preliminary report). Drugs R D. 2003;4:91-101.
ᅵ
Interim Reports on Clinial Trials:
ᅵ
16. 2003
ᅵ
DRUGS IN R&D
Drugs in R and D
(Drugs in Research and Development)
ᅵ
BT-11 – BRAIN STEM GLIOMA
ᅵ
Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA:
ᅵ
a preliminary report.
http://www.ncbi.nlm.nih.gov/pubmed/12718563
Drugs R D. 2003;4(2):91-101
http://www.ncbi.nlm.nih.gov/m/pubmed/12718563
Drugs in R&D 2003;4:91-101
http://www.burzynskiclinic.com/images/stories/Publications/960.pdf
——————————————————————
Pg. 260
ᅵ
1992 – Protocol – ASTROCYTOMA [10]
ᅵ
30% – % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
ᅵ
Pg. 261
ᅵ
10. Burzynski SR, Kubove E, Burzynski B. Phase II clinical trials of antineoplastons A10 and AS2-1 infusions in ASTROCYTOMA. In: Adam D, ed. Recent Advances in Chemotherapy. Munich, Germany: Futramed; 1992:2506-2507.
——————————————————————
Pg. 260
ᅵ
1999 – Protocol – PRIMARY BRAIN TUMORS [11]
ᅵ
36 – Evaluable Patients
ᅵ
9 / 25% – # and % of Patients Showing Complete Response
7 / 19% – # and % of Patients Showing Partial Response
12 / 34% – # and % of Patients Showing Stable Disease
8 / 22% – # and % of Patients Showing Progressive Disease
16 / 44% – # and % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
ᅵ
Pg. 261
ᅵ
11. Burzynski SR, Conde AB, Peters A, et al. A retrospective study of antineoplastons A10 and AS2-1 in PRIMARY BRAIN TUMORS. Clin Drug Invest. 1999;18:1-10.
http://link.springer.com/article/10.2165%2F00044011-199918010-00001
Clinical Drug Investigation, July 1999, Volume 18, Issue 1, pp 1-10
http://link.springer.com/content/pdf/10.2165%2F00044011-199918010-00001.pdf
DOI
10.2165/00044011-199918010-00001
http://www.tlcdoctors.com/documents/aRetrospectiveStudyclinicalDrugInvestigation.pdf
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ
Interim Reports on Clinial Trials:
ᅵ
2. 10/2004
ᅵ
NEURO-ONCOLOGY
ᅵ
BT-20 – Patients With GLIOBLASTOMA MULTIFORME (GBM)
ᅵ
Phase II study of Antineoplastons A10 and AS2-1 (ANP) in recurrent GLIOBLASTOMA MULTIFORME
http://www.burzynskiclinic.com/images/stories/Publications/1218.pdf
Neuro-Oncology. 2004; 6: 384
Volume 6 Issue 4 October 2004
Abstracts from the Society for Neuro-Oncology Ninth Annual Meeting, Toronto, Ontario, Canada, November 18-21, 2004
ᅵ
Pg. 384
ᅵ
5 – Multicentric tumors
ᅵ
20 – surgery:
10 – tumor resection once
8 – tumor resection twice
2 – biopsy only
ᅵ
22 – radiation therapy
10 – chemotherapy
ᅵ
Pg. 385
ᅵ
10/2004 – Protocol – GLIOBLASTOMA MULTIFORME (GBM) which recurred or progressed post surgery, radiation therapy, and / or chemotherapy
ᅵ
22 – Evaluable Patients (Pg. 384)
(6 men / 16 women / 27 – 63 years /47 – median age)
ᅵ
1 / 4.5% – # and % of Patients Showing Complete Response
1 / 4.5% – # and % of Patients Showing Partial Response
12 / 54.5% – # and % of Patients Showing Stable Disease
8 / 36.5% – # and % of Patients Showing Progressive Disease
2 / 9% – # and % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ
Interim Reports on Clinial Trials:
ᅵ
3. 10/2004 (DBSG)
ᅵ
NEURO-ONCOLOGY
ᅵ
Long-term survivals in phase II studies of Antineoplastons A10 and AS2-1 (ANP) in patients with diffuse intrinsic BRAIN STEM GLIOMA
http://www.burzynskiclinic.com/images/stories/Publications/1219.pdf
Neuro-Oncology. 2004; 6: 386
Volume 6 Issue 4 October 2004
ᅵ
60 patients
(31 didn’t meet admission criteria to the study and were treated under Special Exception (SE))
ᅵ
46 – recurrent tumor after previous therapy
ᅵ
14 – progressive diffuse intrinsic brain stem glioma (DBSG) without prior treatment
ᅵ
10/2004 – Protocol – patients with diffuse intrinsic BRAIN STEM GLIOMA (DBSG)
ᅵ
29 – Evaluable Patients
ᅵ
7 / 24% – # and % of Patients Showing Complete Response
6 / 21% – # and % of Patients Showing Partial Response
6 / 21% – # and % of Patients Showing Stable Disease
10 / 34% – # and % of Patients Showing Progressive Disease
13 / 45% – # and % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
——————————————————————
10/2004 – Protocol – patients with diffuse intrinsic BRAIN STEM GLIOMA (DBSG)
ᅵ
31 – Evaluable Patients: Special exception (SE)
ᅵ
5 / 16% – # and % of Patients Showing Complete Response
2 / 6% – # and % of Patients Showing Partial Response
16 / 52% – # and % of Patients Showing Stable Disease
8 / 26% – # and % of Patients Showing Progressive Disease
7 / 22% – # and % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
======================================
COMBINED:
——————————————————————
# and % of Patients Showing Complete Response
7 / 24%
5 / 16% – Special exception (SE)
——————————————————————
# and % of Patients Showing Partial Response
6 / 21%
2 / 6% – Special exception (SE)
——————————————————————
# and % of Patients Showing Stable Disease
6 / 21%
16 / 52% – Special exception (SE)
——————————————————————
# and % of Patients Showing Progressive Disease
10 / 34%
8 / 26% – Special exception (SE)
——————————————————————
# and % of Patients Showing Objective Response
13 / 45%
7 / 22% – Special exception (SE)
ᅵ
Objective response = complete response and partial response
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ
Interim Reports on Clinial Trials:
ᅵ
5. 10/2004
ᅵ
NEURO-ONCOLOGY
ᅵ
BT-12 – Children with PRIMITIVE NEUROECTODERMAL TUMORS (PNET)
ᅵ
Treatment of PRIMITIVE NEUROECTODERMAL TUMORS (PNET) with antineoplastons A10 and AS2-1 (ANP)
ᅵ
Preliminary results of phase II studies
http://www.burzynskiclinic.com/images/stories/Publications/1147.pdf
Neuro-Oncology. 2004; 6: 428
Volume 6 Issue 4 October 2004
Abstracts from the Eleventh International Symposium on Pediatric Neuro-Oncology
ᅵ
17 – recurrent disease or high-risk
ᅵ
10 – Medulloblastoma
5 – pineoblastoma
2 – other primitive neuroectodermal tumors (PNET)
ᅵ
5 – multiple metastases
ᅵ
1 – involvement of the spinal cord
ᅵ
17 – resection
8 – chemotherapy
8 – radiation therapy
8 – high-risk didn’t receive prior chemotherapy and radiation
ᅵ
5.2 months – median antineoplaston administration
ᅵ
10/2004 – Protocol – PRIMITIVE NEUROECTODERMAL TUMORS (PNET)
ᅵ
17 – Patients Accrued
(2 – nonevaluable due to lack of follow-up scans)
15 – Evaluable Patients
(12 months – 23 years / 6 – median age)
ᅵ
3 / 20% – # and % of Patients Showing Complete Response
2 / 13.4% – # and % of Patients Showing Partial Response
5 / 33.3% – # and % of Patients Showing Stable Disease
5 / 33.3% – # and % of Patients Showing Progressive Disease
5 / 33.4% – # and % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
ᅵ
5 – objective response (OR) not treated earlier with radiation therapy and chemotherapy
ᅵ
The study is ongoing and accruing additional patients
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ
Interim Reports on Clinial Trials:
ᅵ
17. 2004
ᅵ
DRUGS IN R&D
Drugs in R and D
(Drugs in Research and Development)
ᅵ
Pg. 317
ᅵ
BT-13 – children with low-grade astrocytoma
ᅵ
BT-23 – children with visual pathway gliomas
ᅵ
Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive MULTICENTRIC GLIOMA.
ᅵ
A Preliminary Report.
http://www.ncbi.nlm.nih.gov/pubmed/15563234
Drugs R&D 2004;5(6):315-326.
http://www.ncbi.nlm.nih.gov/m/pubmed/15563234
Drugs R D. 2004;5(6):315-26
http://www.burzynskiclinic.com/images/stories/Publications/1194.pdf
Pg. 315
ᅵ
incurable recurrent and progressive multicentric glioma
ᅵ
Pgs. 315-316 and 318-319
ᅵ
6 – pilocytic astrocytoma
4 – low-grade astrocytoma
1 – astrocytoma grade 2
1 – visual pathway glioma: biopsy not performed due to dangerous location
ᅵ
Pgs. 318-319
ᅵ
8 – visual pathway glioma
ᅵ
Pg. 315 and 320
ᅵ
16 months – average duration of intravenous antineoplastons
ᅵ
19 months – average duration of oral antineoplastons
ᅵ
1 – non-evaluable due to only 4 weeks of ANP and lack of follow-up scans and died while on treatment due to a non-hemorrhaging brain infarction and was considered a treatment failure
ᅵ
1 – had stable disease discontinued ANP against medical advice and died 4.5 years later
ᅵ
Pg. 316
ᅵ
Previous therapies:
4 – Surgery
4 – Surgery and chemotherapy
1 – Surgery, chemotherapy and radiation
1 – Chemotherapy and radiation
1 – Chemotherapy only
ᅵ
Pgs. 318-319
ᅵ
9 – Surgery (SU)
7 – Chemotherapy (CH)
2 – Radiation (RA)
2 – Biopsy only (Bx)
ᅵ
Pg. 317
ᅵ
progressive (without prior treatment) multicentric glioma (MCG)
ᅵ
Pg. 317 and 320
ᅵ
recurrent (progressive after prior treatment) multicentric glioma (MCG) previously treated with surgery, radiation therapy and / or chemotherapy
ᅵ
Pgs. 318-319
ᅵ
9 – Caucasian
1 – Asian Indian
1 – Latin American
1 – Oriental
ᅵ
Pg. 320
ᅵ
3 – treated under Special Exception (SE) granted by the US FDA
ᅵ
Pgs. 317 and 320
ᅵ
7/31/1996 – (7/31/1996 – 4/3/2002 as of 3/1/2004) Protocol – children with recurrent and progressive MULTICENTRIC GLIOMA (MCG)
ᅵ
Pg. 317
ᅵ
BT-13 – children with low-grade astrocytoma
ᅵ
BT-23 – children with visual pathway gliomas

ᅵ
Pgs. 317 and 320-321
ᅵ
12 – Children Patients Accrued (Pgs. 315-316)
(6 – male / 6 – female)
10 – Evaluable Patients (Pg. 315)
(9 months – 17 years / 9 – median age) (Pgs. 315-316)
ᅵ
4 / 33% – # and % of Patients Showing Complete Response
3 / 25% – # and % of Patients Showing Partial Response
4 / 33% – # and % of Patients Showing Stable Disease
0 / 0% – # and % of Patients Showing Progressive Disease
1 / 9% – # and % of Patients Non-evaluable
7 / 58% – # and % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
ᅵ
Pg. 321
ᅵ
3 – continue oral ANP
ᅵ
2 – expired
ᅵ
Pgs. 315 and 320
ᅵ
The study continues with ongoing accrual of additional new patients
ᅵ
Pg. 317
ᅵ
Responses confirmed by radiologists not affiliated with Burzynski Clinic (BC)
ᅵ
Radiologists and oncologists from FDA evaluated films and medical records of patients who obtained complete response (CR) and partial response (PR)
ᅵ
Responses confirmed by radiologists not affiliated with Burzynski Clinic (BC)
——————————————————————
Pgs. 324-325
ᅵ
COMPARE: Mamelak et al. [17]
ᅵ
8 – treated with various chemotherapy regimens
1 – radiation therapy and chemotherapy
1 – radiation therapy alone
1 – no treatment
ᅵ
1986 (1986 – 1992) – Protocol – MULTICENTRIC GLIOMA
ᅵ
11 – Patients Accrued
11 – Evaluable Patients
ᅵ
2 / 18% – # and % of Patients Showing Remission (definition of remission wasn’t provided)
5 / 46% – # and % of Patients Showing Stable Disease
4 / 36% – # and % of Patients Died
3 – from disease progression
1 – from chemotherapy-induced toxicity
======================================
COMPARE COMBINED:
======================================
# and % of Patients Showing Complete Response
——————————————————————
4 / 33% – Antineoplastons
ᅵ
2 / 18% – # and % of Patients Showing Remission (definition of remission wasn’t provided)
Mamelak et al. [17]
——————————————————————
# and % of Patients Showing Partial Response
——————————————————————
3 / 25% – Antineoplastons
ᅵ
2 / 18% – # and % of Patients Showing Remission (definition of remission wasn’t provided)
Mamelak et al. [17]
——————————————————————
# and % of Patients Showing Stable Disease
——————————————————————
4 / 33% – Antineoplastons
ᅵ
5 / 46% – Mamelak et al. [17]
——————————————————————
# and % of Patients Showing Progressive Disease
——————————————————————
0 / 0% – Antineoplastons
ᅵ
4 / 36% – # and % of Patients Died
Mamelak et al. [17]
——————————————————————
# and % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
——————————————————————
7 / 58% – Antineoplastons
ᅵ
2 / 18% – Mamelak et al. [17]
——————————————————————
Pg. 326
ᅵ
17. Mamelak AN, Prados MD, Obana WG, et al. Treatment options and prognosis for MULTICENTRIC juvenile pilocytic astrocytoma. J Neurosurg. 1994; 81: 24-30
http://www.ncbi.nlm.nih.gov/pubmed/8207524/
J Neurosurg. 1994 Jul;81(1):24-30.
http://www.ncbi.nlm.nih.gov/m/pubmed/8207524/
Department of Neurological Surgery, School of Medicine, University of California, San Francisco.
http://thejns.org/doi/abs/10.3171/jns.1994.81.1.0024?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dpubmed&amp;
Journal of Neurosurgery
Vol. 81: 24-30 (Volume publication date: July 1994)
DOI: 10.3171/jns.1994.81.1.0024
======================================
Pg. 325
ᅵ
COMPARE: Chamberlain and Grafe. [38]
ᅵ
1995 – Protocol – solitary recurrent chiasmatic hypothalamic GLIOMAS treated with oral etoposide

ᅵ
14 – Patients Accrued
14 – Evaluable Patients
ᅵ
1 / 7% – # and % of Patients Showing Complete Response
4 / 29% – # and % of Patients Showing Partial Response
3 / 21% – # and % of Patients Showing Stable Disease
6 / 43% – # and % of Patients Showing Progressive Disease
5 / 36% – # and % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
======================================
COMPARE COMBINED:
======================================
# and % of Patients Showing Complete Response
——————————————————————
4 / 33% – Antineoplastons
ᅵ
1 / 7% – Chamberlain and Grafe. [38]
——————————————————————
# and % of Patients Showing Partial Response
——————————————————————
3 / 25% – Antineoplastons
ᅵ
4 / 29% – Chamberlain and Grafe. [38]
——————————————————————
# and % of Patients Showing Stable Disease
——————————————————————
4 / 33% – Antineoplastons
ᅵ
3 / 21% – Chamberlain and Grafe. [38]
——————————————————————
# and % of Patients Showing Progressive Disease
——————————————————————
0 / 0% – Antineoplastons
ᅵ
6 / 43% – Chamberlain and Grafe. [38]
——————————————————————
# and % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
——————————————————————
7 / 58% – Antineoplastons
ᅵ
5 / 36% – Chamberlain and Grafe. [38]
——————————————————————
Pg. 326
ᅵ
38. Chamberlain MC, Grafe MR. Recurrent chiasmatic-hypothalamic GLIOMA treated with oral etoposide. J Clin Oncol 1995; 13: 2072-6
http://www.ncbi.nlm.nih.gov/pubmed/7636550/
J Clin Oncol. 1995 Aug;13(8):2072-6.
http://www.ncbi.nlm.nih.gov/m/pubmed/7636550/
Department of Neurosciences, University of California, San Diego, La Jolla, USA.
http://m.jco.ascopubs.org/content/13/8/2072.long
Arch Neurol. 1995 May;52(5):509-13.
http://www.ncbi.nlm.nih.gov/pubmed/7733847/
Department of Neurosciences, University of California-San Diego, USA.
http://www.ncbi.nlm.nih.gov/m/pubmed/7733847/
Arch Neurol. 1995;52(5):509-513. doi:10.1001/archneur.1995.00540290099024.
http://archneur.jamanetwork.com/Mobile/article.aspx?articleid=593460
======================================
COMPARE: The Pediatric Oncology Group. [39]
ᅵ
10/2000 – Protocol – solitary progressive OPTIC PATHWAY TUMORS with carboplatin
ᅵ
50 – Patients Accrued
50 – Evaluable Patients
ᅵ
2 / 4% – # and % of Patients Showing Partial Response
37 / 74% – # and % of Patients Showing Stable Disease
11 / 22% – # and % of Patients Showing Progressive Disease
2 / 4% – # and % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
======================================
COMPARE COMBINED:
======================================
# and % of Patients Showing Partial Response
——————————————————————
3 / 25% – Antineoplastons
ᅵ
2 / 4% – The Pediatric Oncology Group. [39]
——————————————————————
# and % of Patients Showing Stable Disease
——————————————————————
4 / 33% – Antineoplastons
ᅵ
37 / 74% – The Pediatric Oncology Group. [39]
——————————————————————
# and % of Patients Showing Progressive Disease
——————————————————————
0 / 0% – Antineoplastons
ᅵ
11 / 22% – The Pediatric Oncology Group. [39]
——————————————————————
# and % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
——————————————————————
7 / 58% – Antineoplastons
ᅵ
2 / 4% – The Pediatric Oncology Group. [39]
——————————————————————
39. Mahoney DH, Cohen ME, Friedman HS, et al. Carboplatin is effective therapy for young children with progressive OPTIC PATHWAY TUMORS: a Pediatric Oncology Group phase II study. Neuro-oncol 2000; 2: 213-20
http://www.ncbi.nlm.nih.gov/pubmed/11265230/
Neuro Oncol. 2000 Oct;2(4):213-20.
http://www.ncbi.nlm.nih.gov/m/pubmed/11265230/
Baylor College of Medicine, Houston, TX, USA.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1920597/
ᅵ
http://neuro-oncology.oxfordjournals.org/content/2/4/213.full.pdf
======================================
COMPARE COMBINED (4):
======================================
# and % of Patients Showing Complete Response
——————————————————————
4 / 33% – Antineoplastons
ᅵ
2 / 18% – # and % of Patients Showing Remission (definition of remission wasn’t provided)
Mamelak et al. [17]
ᅵ
1 / 7% – Chamberlain and Grafe. [38]
——————————————————————
# and % of Patients Showing Partial Response
——————————————————————
3 / 25% – Antineoplastons
ᅵ
2 / 18% – # and % of Patients Showing Remission (definition of remission wasn’t provided)
Mamelak et al. [17]
ᅵ
4 / 29% – Chamberlain and Grafe. [38]
ᅵ
2 / 4% – The Pediatric Oncology Group. [39]
——————————————————————
# and % of Patients Showing Stable Disease
——————————————————————
4 / 33% – Antineoplastons
ᅵ
5 / 46% – Mamelak et al. [17]
ᅵ
3 / 21% – Chamberlain and Grafe. [38]
ᅵ
37 / 74% – The Pediatric Oncology Group. [39]
——————————————————————
# and % of Patients Showing Progressive Disease
——————————————————————
0 / 0% – Antineoplastons
ᅵ
4 / 36% – # and % of Patients Died
Mamelak et al. [17]
ᅵ
6 / 43% – Chamberlain and Grafe. [38]
ᅵ
11 / 22% – The Pediatric Oncology Group. [39]
——————————————————————
# and % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
——————————————————————
7 / 58% – Antineoplastons
ᅵ
2 / 18% – Mamelak et al. [17]
ᅵ
5 / 36% – Chamberlain and Grafe. [38]
ᅵ
2 / 4% – The Pediatric Oncology Group. [39]
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ
Interim Reports on Clinial Trials:
ᅵ
18. 6/2005
ᅵ
INTEGRATIVE CANCER THERAPIES
ᅵ
BT-12 – children with PRIMITIVE NEUROECTODERMAL TUMORS (PNET)
ᅵ
CAN-01 (CAN-1) – PATIENTS WITH REFRACTORY MALIGNANCIES
ᅵ
Long-term survival of high-risk pediatric patients with PRIMITIVE NEUROECTODERMALTUMORS treated with Antineoplastons A10 and AS2-1
http://www.ncbi.nlm.nih.gov/pubmed/15911929
Integrative Cancer Therapies 2005;4(2):168-177
http://www.ncbi.nlm.nih.gov/m/pubmed/15911929
Integr Cancer Ther. 2005 Jun;4(2):168-77
http://www.burzynskiclinic.com/images/stories/Publications/1220.pdf
DOI: 10.1177/1534735405276835
http://m.ict.sagepub.com/content/4/2/168.long?view=long&pmid=15911929
Volume 4 Number 2 June 2005
ᅵ
Pgs. 168-171
ᅵ
Previous treatments:
12 – surgery (resections)
(1 had biopsy only – suboccipital craniotomy)
6 – chemotherapy
6 – radiation therapy
ᅵ
6 – hadn’t received prior chemotherapy or radiation
ᅵ
20 months – average antineoplastons administered
ᅵ
Pgs. 168 and 170
ᅵ
8 – Medulloblastoma
3 – pineoblastoma
2 – other PRIMITIVE NEUROECTODERMALTUMORS (PNET)
(1 – PNET with neuronal and astrocytic differentiation / 1 – Supratentorial)
ᅵ
Pg. 169
ᅵ
12 – tumor progressed prior to ANP
8 – multiple cerebral metastases
1 – residual tumor after partial resection
1 – involvement of the spinal cord
ᅵ
Pgs. 169-170
ᅵ
CAN-01 study published. [2]
3 children with PNET were treated in this study – completed / closed for admission
ᅵ
Pg. 176
ᅵ
2. Burzynski SR, Conde AB, Peters A, et al. A retrospective study of antineoplastons A10 and AS2-1 in PRIMARY BRAIN TUMORS. Clin Drug Invest. 1999;18:1-10.
http://link.springer.com/article/10.2165%2F00044011-199918010-00001
Clinical Drug Investigation, July 1999, Volume 18, Issue 1, pp 1-10
http://link.springer.com/content/pdf/10.2165%2F00044011-199918010-00001.pdf
ᅵ
http://www.tlcdoctors.com/documents/aRetrospectiveStudyclinicalDrugInvestigation.pdf
Pg. 170
ᅵ
The group of long-term survivors:
6 – children (5 males / 1 female)
Diagnosed from age 1 – 9
3 – medulloblastoma
2 – other PNET
1 – pineoblastoma
3 – disseminated disease
1 – involvement of brainstem
5 – prior subtotal tumor resection
1 – biopsy only: treated with combination chemotherapy
6 – didn’t have radiation therapy
ᅵ
3 / 50% – # and % of Patients Showing Complete Response
2 / 33% – # and % of Patients Showing Stable Disease
1 /17% – # and % of Patients Showing Progressive Disease and subsequently received standard radiation therapy
3 / 50% – # and % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
——————————————————————
Pgs. 170 and 172
ᅵ
Case patient 1 – complete response (CR) passed away after 6 years, 10 months from start of ANP, 3 years after discontinuation of ANP: cause of death recurrent pneumonia, possibly due to chronic immunosuppression from chemotherapy administered prior to ANP
ᅵ
Pgs. 171- 173
ᅵ
Case patient 2 – stable disease (SD) / BT-12 / male / age 4 at admission / white / 5/28/1996 diagnosed (7/8/1996 – 3/25/1997 treatment: 256 days) / medulloblastoma / lost to follow-up after 6 years, 3 months, but believed to be alive since no confirmation of death
ᅵ
Case patient 8 – progressive disease (PD) / BT-12 / male / age 9 at admission / white / 10/16/1997 diagnosis (5/8/1998 – 11/3/1998 treatment: 157 days) / medulloblastoma / lost to follow-up after approximately 5 years, but believed to be alive since no confirmation of death
——————————————————————
3 – (7/27/2004) alive from 7+ – 10+ years from beginning of treatment
ᅵ
These 3 underwent partial tumor resection, but none were treated with chemotherapy and radiation therapy before ANP
ᅵ
Case patient 4 – complete response (CR) / BT-12 / female / age 1 at admission / white / 12/18/1996 diagnosis (2/27/1997 – 3/6/2003 treatment: 2,012 days) / pineoblastoma / off ANP / never treated with radiation therapy or chemotherapy / lives normal life for more than 7.5 years since ANP started
ᅵ
Case patient 5 – stable disease (SD) / BT-12 / male / age 9 at admission / white / 3/18/1997 admission (5/1/1997 – 1/27/1998 treatment: 163 days) / supratentorial / as a result of ANP and thereafter underwent radiation therapy
ᅵ
Case patient 11 – complete response (CR) / CAN-01 / male / age 2 at admission / white / 3/1/1994 admission (4/13/1994 – 6/16/1999 treatment: 952 days) / medulloblastoma / off ANP / never treated with radiation therapy or chemotherapy / lives normal life for more than 10 years, 4 months since ANP started
ᅵ
Pg. 172
ᅵ
479 – average days on treatment
157 – median days on treatment
ᅵ
Pgs. 168-170 and 176
ᅵ
4/13/1994 (4/13/1994 – 12/4/2001 as of 8/1/2004)
Protocol – poor-risk recurrent disease or
high risk
(Pgs. 168-171)
ᅵ
10 – BT-12 (7 males / 3 females)
3 – CAN-01 (3 males)
ᅵ
13 – Caucasian Children Patients Accrued
(10 males / 3 females)
13 – Evaluable Patients
(1 – 11 years / 5 years, 7 months – median age: Pgs. 168-171)
3 – younger than 3
ᅵ
3 / 23% – # and % of Patients Showing Complete Response
1 / 8% – # and % of Patients Showing Partial Response
4 / 31% – # and % of Patients Showing Stable Disease
1 / 8% – # and % of Patients Showing Progressive Disease
4 / 31% – # and % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
ᅵ
Study ongoing and accruing new additional patients to BT-12 study
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ
Interim Reports on Clinial Trials:
ᅵ
7. 7/2005
ᅵ
BT-11 – BRAIN STEM GLIOMA
ᅵ
Targeted therapy with ANP in children less than 4 years old with inoperable BRAIN STEM GLIOMAs.
Neuro-Oncology. 2005; 7:300.
http://www.burzynskiclinic.com/images/stories/Publications/1224.pdf
Volume 7 Issue 3 July 2005
Abstracts from the World Federation of Neuro-Oncology Meeting
ᅵ
2 trials (study and special exception (SE))
ᅵ
Intrinsic diffuse brain stem glioma (BSG)
ᅵ
7 – no biopsy: dangerous tumor location
2 – anaplastic astrocytoma
1 – pilocytic astrocytoma
ᅵ
4 – not treated prior to antineoplastons
3 – failed prior radiation and chemotherapy
2 – tumor resection
1 – stable disease after radiation
ᅵ
9.5 months – median duration of ANP administration
ᅵ
7/2005 – Protocol – BRAIN STEM GLIOMA (BSG)
ᅵ
10 – Evaluable assessable Patients
(Less than 4 years old – 3 months 3 years)
ᅵ
3 / 30% – # and % of Patients Showing Complete Response
4 / 40% – # and % of Patients Showing Stable Disease
3 / 30% – # and % of Patients Showing Progressive Disease
3 / 30% – # and % of Patients Showing Objective Response

Objective response = complete response and partial response
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ
Interim Reports on Clinial Trials:
ᅵ
19. 3/2006
ᅵ
BT-03
ᅵ

ᅵ
BT-11 – BRAIN STEM GLIOMA (BSG)
ᅵ
BT-18 – 6. MIXED GLIOMA: ADULT PATIENTS WITH MIXED GLIOMA – “mixed glioma”, a type of primary malignant brain tumor (PMBT)
ᅵ
BT-22 – 8. CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS
ᅵ
CAN-01 (CAN-1) – PATIENTS WITH REFRACTORY MALIGNANCIES
ᅵ
Targeted therapy with Antineoplastons A10 and AS2-1 of high grade, recurrent, and progressive BRAINSTEM GLIOMA.
Integrative Cancer Therapies 2006;5(1):40-47
http://www.ncbi.nlm.nih.gov/pubmed/16484713
Integr Cancer Ther. 2006 Mar;5(1):40-7
http://www.ncbi.nlm.nih.gov/m/pubmed/16484713
DOI: 10.1177/1534735405285380
http://www.burzynskiclinic.com/images/stories/Publications/5825.pdf
ᅵ
http://m.ict.sagepub.com/content/5/1/40.long?view=long&pmid=16484713
Pgs. 40-41
ᅵ
4 phase 2 trials
ᅵ
BRAINSTEM GLIOMA (BSG)
ᅵ
patients with inoperable tumor of high-grade pathology (HBSG)
glioblastoma
ᅵ
recurrent diffuse intrinsic glioblastomas and ANAPLASTIC ASTROCYTOMAs of brainstem
ᅵ
Pgs. 40-43
ᅵ
14 – anaplastic HBSG (patients with inoperable tumor of high-grade pathology (HBSG))
(13 – Anaplastic astrocytoma (AA) / 1 – Anaplastic astrocytoma (AA) / mixed glioma)
ᅵ
4 – glioblastomas (gliobastoma multiforme (GBM)) (GBM / brain stem glioma (BSG))
ᅵ
14 – diffuse intrinsic tumors
ᅵ
12 – tumor recurrence
ᅵ
Previous therapies:
5 – surgery (SU)
4 – surgery (SU) / chemotherapy (CH) / radiation therapy (RA)
4 – surgery (SU) / radiation therapy (RA)
2 – biopsy (Bx) / chemotherapy (CH) / radiation therapy (RA)
1 – chemotherapy (CH) / radiation therapy (RA)
1 – biopsy (Bx) / radiation therapy (RA)
1 – biopsy (Bx)
ᅵ
6 – didn’t have radiation therapy or chemotherapy
(5 – underwent surgical resection / 1 – underwent biopsy only)
ᅵ
Pgs. 40-44
ᅵ
5 months – mediation duration of antineoplaston administration
ᅵ
216 – Average days on antineoplastons
154 – Median days on antineoplastons
ᅵ
Pg. 43
ᅵ
13 – DBSG
2 – Exophytic
1 – DBSG / multifocal
1 – Multifocal
1 – Cervico-medullary
ᅵ
Pg. 44
ᅵ
High-grade, recurrent, and progressive brainstem gliomas
ᅵ
Pgs. 40 and 45-46
ᅵ
2+ years – Most patients with newly diagnosed High-grade brain stem gliomas (HBSG) don’t survive more than
ᅵ
2 years – Most patients with brainstem glioma fail standard radiation therapy and chemotherapy and don’t survive longer
ᅵ
6 months – patients with recurrent tumors survive no more than, despite standard treatment
ᅵ
Pg. 45
ᅵ
12 – most likely tumor related deaths
3 – alive and tumor free
2 – aspiration pneumonia possible deaths
1 – death due to pulmonary embolism
ᅵ
Pgs. 40-42 and 44-45
ᅵ
7/12/1988 (7/12/1988 – 11/13/2003 as of 6/10/2005) – Protocol – recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of the brainstem high-grade pathology (HBSG)
ᅵ
18 – Evaluable Patients (Pgs. 40-43)
(8 males / 10 females – Pgs. 42-43)
2 – 42 years / 10 – median age: Pgs. 42-43
ᅵ
Pg. 43
ᅵ
BT-03 – 1 / female
BT-11 – 13 (8 males/5 females)
BT-18 – 1 / female
BT-22 – 2 / females
CAN-01 – 1 / female
ᅵ
2 / 11% – # and % of Patients Showing Complete Response
2 / 11% – # and % of Patients Showing Partial Response
7 / 39% – # and % of Patients Showing Stable Disease
7 / 39% – # and % of Patients Showing Progressive Disease
4 / 22% – # and % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
ᅵ
Pg. 42
ᅵ
BT-11 – ongoing: brain stem glioma (BSG)
BT-18 – ongoing: mixed gliomas (1 – diagnosed with mixed glioma of brainstem)
ᅵ
BT-03 – completed. [14]
CAN-01 – completed. [15]
ᅵ
Pg. 47
ᅵ
14. Burzynski SR, Kubove E, Burzynski B. Phase II clinical trials of antineoplastons A10 and AS2-1 infusions in ASTROCYTOMA. In: Adam D, ed. Recent Advances in Chemotherapy. Munich, Germany: Futuramed; 1992
ᅵ
15. Burzynski SR, Conde AB, Peters A, et al. A retrospective study of antineoplastons A10 and AS2-1 in PRIMARY BRAIN TUMORS. Clin Drug Invest. 1999;18:1-10.
http://link.springer.com/article/10.2165%2F00044011-199918010-00001
Clinical Drug Investigation, July 1999, Volume 18, Issue 1, pp 1-10
http://link.springer.com/content/pdf/10.2165%2F00044011-199918010-00001.pdf
ᅵ
http://www.tlcdoctors.com/documents/aRetrospectiveStudyclinicalDrugInvestigation.pdf
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ
Interim Reports on Clinial Trials:
ᅵ
8. 10/2006
ᅵ
BT-11 – BRAIN STEM GLIOMA
ᅵ
Treatment of multicentric BRAINSTEM GLIOMAs with antineoplastons (ANP) A10 and AS2-1.
Neuro-Oncology. 2006; 8:466.
http://www.burzynskiclinic.com/images/stories/Publications/2105.pdf
Volume 8 Issue 4 October 2006
Abstracts for the Eleventh Annual Meeting of the Society for Neuro-Oncology (SNO)
ᅵ
Brainstem gliomas and multicentric tumors (MBSG)
ᅵ
95% – diffuse intrinsic brain stem glioma
5% – cervicomedullary tumor
ᅵ
37% – biopsy performed
4 – low-grade glioma
3 – high-grade glioma
ᅵ
60% – Tumor recurrence after previous standard treatment
ᅵ
4.5 months – median duration antineoplastons
ᅵ
10/2006 – Protocol – BRAINSTEM GLIOMAS and MULTICENTRIC TUMORS (MBSG)
ᅵ
19 – Evaluable Patients
(3.9 – 40.8 years / 9.2 – median age)
90% less than 18 years old
ᅵ
2 / 11% – # and % of Patients Showing Complete Response
1 / 5% – # and % of Patients Showing Partial Response
7 / 37% – # and % of Patients Showing Stable Disease
9 / 47% – # and % of Patients Showing Progressive Disease
3 / 16% – # and % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ
Interim Reports on Clinial Trials:
ᅵ
9. 4/2007 (NDBSG)
ᅵ
BT-11 – BRAIN STEM GLIOMA
ᅵ
Phase II studies of Antineoplastons A10 and AS 2-1 (ANP) in children with newly diagnosed diffuse, intrinsic BRAINSTEM GLIOMAs.
Neuro-Oncology 2007; 9:206.
http://www.burzynskiclinic.com/images/stories/Publications/4021.pdf
Volume 9 Issue 2 April 2007
Abstracts from the Twelfth International Symposium on Pediatric Neuro-Oncology
ᅵ
5 – high-grade gliomas
ᅵ
8 months – median duration of treatment
ᅵ
4/2007 – Protocol – newly diagnosed diffuse, intrinsic BRAINSTEM GLIOMAs (NDBSG)
ᅵ
20 – Evaluable Assessable Children Patients
(3 months – 20 years / age)
ᅵ
6 / 30% – # and % of Patients Showing Complete Response
2 / 10% – # and % of Patients Showing Partial Response
4 / 20% – # and % of Patients Showing Stable Disease
8 / 40% – # and % of Patients Showing Progressive Disease
8 / 40% – # and % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
======================================
COMPARE: standard radiation therapy in combination with chemotherapy (RAT) (Mandell et al. 1999) (6/1992 – 10/1997)
ᅵ
2% – % of Patients Showing Complete Response
31% – % of Patients Showing Partial Response
33% – % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
ᅵ
Mandell LR, Kadota R, Freeman C, et al. There is no role for hyperfractionated radiotherapy in the management of children with newly diagnosed diffuse intrinsic BRAIN STEM TUMORS: results of pediatric oncology group phase III trial comparing conventional vs. hyperfractionated radiotherapy. Int J Radiat Oncol Biol Phys. 1999;43:959-964.
http://www.ncbi.nlm.nih.gov/pubmed/10192340/
Int J Radiat Oncol Biol Phys. 1999 Mar 15;43(5):959-64.
http://www.ncbi.nlm.nih.gov/m/pubmed/10192340/
International Journal of Radiation Oncology*Biology*Physics
Volume 43, Issue 5, 15 March 1999, Pages 959–964
http://www.sciencedirect.com/science/article/pii/S036030169800501X
Department of Radiation Oncology, Mount Sinai Medical Center, New York, NY, USA.
======================================
COMPARE COMBINED:
——————————————————————
Overall survival (OS):
——————————————————————
40% – 2 years: Antineoplastons (ANP)
ᅵ
7% – 2 years: standard radiation therapy in combination with chemotherapy (RAT)
——————————————————————
30% – 5 years: Antineoplastons (ANP)
ᅵ
0% – 5 years: standard radiation therapy in combination with chemotherapy (RAT)
——————————————————————
Median survival (MST)
——————————————————————
16.4 months – Antineoplastons (ANP)
ᅵ
8.5 months – standard radiation therapy in combination with chemotherapy (RAT)
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ
2007 – Recent clinical trials in diffuse intrinsic BRAINSTEM GLIOMA
ᅵ
Review Article
http://www.cancer-therapy.org/CT/v5/B/HTML/42._Burzynski,_379-390.html
Cancer Therapy Vol 5, 379-390, 2007
ᅵ
chart on page 172 (page 8 of PDF):
http://www.burzynskiclinic.com/images/stories/Publications/1252.pdf
2006 Adis – Pediatr Drugs 2006; 8 (3)
ᅵ
Pg. 172
ᅵ
Treatments for Astrocytic Tumors
ᅵ
Table II. Treatment of diffuse, intrinsic BRAINSTEM GLIOMA in children
ᅵ
Burzynski et al. [88] – Reference
ᅵ
Phase II – Study Type
ᅵ
(no. of pts) – pts = patients
ᅵ
RP (30 pts) – RP = recurrent and progressive tumor – Tumor type
ᅵ
ANP = antineoplastons A10 and AS2-1 – Treatment
ᅵ
[% (no.)]
27% (8) – CR = complete response
20% (6) – PR = partial response
23% (7) – SD = stable disease
30% (9) – PD = progressive disease
ᅵ
Pg. 177
ᅵ
88. Burzynski SR, Weaver RA, Janicki T. Long-term survival in phase II studies of antineoplastons A10 and AS2-1 (ANP) in patients with diffuse intrinsic BRAIN STEM GLIOMA [abstract]. Neuro-oncol 2004; 6: 386
ᅵ
Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive MULTICENTRIC GLIOMA : a preliminary report.
http://www.ncbi.nlm.nih.gov/pubmed/15563234
Drugs R D. 2004;5(6):315-26
http://www.ncbi.nlm.nih.gov/m/pubmed/15563234
Pg. 172
ᅵ
Burzynski et al. [89] – Reference
ᅵ
Phase II – Study Type
ᅵ
(no. of pts) – pts = patients
ᅵ
RPS (10 pts) – RPS = recurrent and progressive tumors in children aged <4y – Tumor type
{(66) = most in a study}
ᅵ
ANP = antineoplastons A10 and AS2-1 – Treatment
ᅵ
[% (no.)]
30% (3) – CR = complete response
{27% (8) = next best study}
[% (no.)]
0% (0) – PR = partial response
{56% (1) = next best}
[% (no.)]
40% (4) – SD = stable disease
{44% (25) = best}
[% (no.)]
30% (3) – PD = progressive disease
{23% (13) = best}
ᅵ
(Above, I also provide the best next case to compare to)
ᅵ
Pg. 177
ᅵ
89. Burzynski SR, Weaver RA, Janicki TJ, et al. Targeted therapy with ANP in children less than 4 years old with inoperable BRAIN STEM GLIOMAS [abstract]. Neuro-oncol 2005; 7: 300
ᅵ
Long-term survival of high-risk pediatric patients with PRIMITIVE NEUROECTODERMAL TUMORS treated with antineoplastons A10 and AS2-1.
http://www.ncbi.nlm.nih.gov/pubmed/15911929
Integr Cancer Ther. 2005 Jun;4(2):168-77
http://www.ncbi.nlm.nih.gov/m/pubmed/15911929
Pg. 173
ᅵ
1.4.3 Targeted Therapy
ᅵ
“…multi-targeted therapy with ANP has shown promising results [12;88-91]”
ᅵ
Pg. 176
ᅵ
90. Burzynski SR, Lewy RI, Weaver RA, et al. Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA: a preliminary report. Drugs R D 2003; 4: 91-101
ᅵ
Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA: a preliminary report.
http://www.ncbi.nlm.nih.gov/pubmed/12718563
Drugs R D. 2003;4(2):91-101
http://www.ncbi.nlm.nih.gov/m/pubmed/12718563
91. Burzynski SR, Weaver RA, Janicki T. et al. Targeted therapy with antineoplastons A10 and AS2-1 (ANP) of high-grade, recurrent and progressive BRAIN STEM GLIOMA. Integr Cancer Ther 2006 Mar; 5 (1): 40-7
ᅵ
Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive BRAINSTEM GLIOMA.
http://www.ncbi.nlm.nih.gov/pubmed/16484713
Integr Cancer Ther. 2006 Mar;5(1):40-7
http://www.ncbi.nlm.nih.gov/m/pubmed/16484713
30 evaluable patients with recurrent and progressive DBSG
ᅵ
“>40% of patients survived for more than 2 years
30% more than 5 years.”

ᅵ
27% – CR – Complete Response
20% – PR – Partial Response
23% – SD – Stable Disease
30% – PD – Progressive Disease
[12,88]

ᅵ
Pg. 175
ᅵ
12. Burzynski SR Targeted therapy for BRAIN TUMORS In: Columbus, F editor. BRAIN CANCER research progress. New York: Nova Science Publishers Inc 2005
ᅵ
Pg. 173
ᅵ
10 evaluable children
aged <4 years diagnosed with DBSG treated with ANP
youngest 3-month-old infant
[89]

ᅵ
30% – CR – Complete Response
40% – SD – Stable Disease
30% – PD – Progressive Disease
[89]

ᅵ
“The results are compiled in table II.”
ᅵ
Pg. 174
ᅵ
2.3. Targeted Therapy
ᅵ
Multi-targeted ANP therapy is free from chronic toxicity in children and adults based on the results of numerous clinical studies involving
ᅵ
1652 adults
335 children
[147]

ᅵ
Pg. 178
ᅵ
147. Burzynski SR. Annual report to the FDA, IND 43,742, 2006
ᅵ
Pg. 174
ᅵ
Long-term follow-up of children treated with ANP for ASTROCYTOMAS revealed:
normal development
no cognitive or endocrine deficiencies
normal fertility
ᅵ
>5 years – substantial number of patients tumor free
>17 years – follow-up period for some patients

ᅵ
Pg. 169
ᅵ
1.1.4. Targeted Therapy
ᅵ
Clinical trials with agents affecting single targets are in progress and the preliminary results of multi-targeted therapy with
antineoplastons (ANP) A10
and
AS2-1 have been reported
[39]
ᅵ
small group of patients with progressive LGA, ANP
60% – CR rate – Complete Response
10% – PR rate – Partial Response
median survival 7 years 9 months
maximum survival of more than 15 years
[39]

ᅵ
LGA = Low-Grade ASTROCYTOMA
ᅵ
Table I. Selected chemotherapy regimens for the treatment of low-grade ASTROCYTOMA in children
ᅵ
Burzynski [39] – Reference
ᅵ
Phase II d – d = Preliminary results – Study type
ᅵ
P = progressive tumor – Tumor type
ᅵ
(no. of pts) – pts = patients
ᅵ
ANP (10 pts) – ANP = antineoplastons A10 and AS2-1 – Treatment
{(78) = most in a study}
ᅵ
OS [%] = overall survival
100% (1 year) – 90% (3 year) – Efficacy
ᅵ
MST = median survival time
93 months
{96 (1 year) next closest}
ᅵ
CR [% (no.)]
60% (6) – CR = complete response
{24 (11) next closest}
PR [% (no.)]
10% (1) – PR = partial response
{60% (9) best other study}
[% (no.)]
30% (3) – SD = stable disease + MR = minor response
{70% (14) best other study}
[% (no.)]
0% (0) – PD = progressive disease
{4% (2) next closest}
ᅵ
PFS (%)
90% (1 year) – 90% (3 years) – PFS = progression-free survival
{100% (1 year) – 68% (3 years) best other study}
ᅵ
(Above, I also provide the best next case to compare to)
ᅵ
Pg. 176
ᅵ
39. Burzynski SR Clinical application of body epigenetic system: multi-targeted therapy for PRIMARY BRAIN TUMORS. World and Ehrlich Conference on Dosing of Magic Bullets; 2004 Sep 9-11 Nurnberg

ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ
Interim Reports on Clinical Trials:
ᅵ
10. 6/2008 (OPG)
ᅵ
BT-23 – CHILDREN WITH VISUAL PATHWAY GLIOMA
ᅵ
Phase II study of antineoplastons A10 and AS2-1 (ANP) in CHILDREN WITH optic PATHWAY GLIOMA:
ᅵ
A preliminary report
http://www.burzynskiclinic.com/images/stories/Publications/7287.pdf
Neuro-Oncology 2008; 10:450
Volume 10 Issue 3 June 2008
ᅵ
7 / 58% – solitary tumors
5 / 42% – multicentric
ᅵ
5 / 42% – pilocytic astrocytoma
4 / 33% – low-grade astrocytoma
2 / 17% – neurofibromatosis 1
ᅵ
8 / 67% – failed chemotherapy alone
3 / 25% – didn’t have biopsy
2 / 17% – developed progression after surgery
2 / 17% – not treated prior but developed progressive tumors
ᅵ
16.5 months (1 year 4.5 months) – Median antineoplaston treatment
ᅵ
6/2008 – Protocol – CHILDREN WITH optic PATHWAY GLIOMA
ᅵ
12 Evaluable Children Patients
(7 months – 16 years / 6 years 3 months – Median age)
ᅵ
3 / 25% – # and % of Patients Showing Complete Response
2 / 17% – # and % of Patients Showing Partial Response
6 / 50% – # and % of Patients Showing Stable Disease
1 / 8% – # and % of Patients Showing Progressive Disease
5 / 42% – # and % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ
Interim Reports on Clinical Trials:
ᅵ
11. 10/2008
ᅵ
(BT-8 – PATIENTS WITH ANAPLASTIC ASTROCYTOMA: 9)
ᅵ
(BT-15 – ADULT PATIENTS WITH ANAPLASTIC ASTROCYTOMA: 17)
ᅵ
Phase II study of antineoplastons A10 and AS2-1 (ANP) in PATIENTS WITH newly diagnosed ANAPLASTIC ASTROCYTOMA:
ᅵ
A preliminary report
http://www.burzynskiclinic.com/images/stories/Publications/7853.pdf
Volume 10 Issue 5 October 2008
Neuro-Oncology 2008; 10:821
Abstracts for the Thirteenth Annual Meeting of the Society for Neuro-Oncology, November 20-23, 2008
ᅵ
Newly Diagnosed and Recurrent ANAPLASTIC ASTROCYTOMA (AA):
Normal 5-year Survival Rate:
Less than %30
ᅵ
FDA monitored study
ᅵ
14 / 70% – Biopsy only
6 / 30% – Surgery
0 / 0% – received radiation or chemotherapy before antineoplastons (ANP)
ᅵ
5.7 months – Median Duration of Treatment
ᅵ
10/2008 – Protocol – Patients with Newly Diagnosed ANAPLASTIC ASTROCYTOMA (AA)
ᅵ
20 Evaluable Patients
(22 – 64 years / 40 – Median age)
ᅵ
5 / 25% – # and % of Patients Showing Complete Response
8 / 40% – # and % of Patients Showing Stable Disease
7 / 35% – # and % of Patients Showing Progressive Disease
5 / 25% – # and % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
ᅵ
In study Patients achieved substantially higher Percentage of Complete Response (CR) compared to study of antineoplastons (ANP) in RECURRENT Anaplastic Astrocytoma (AA)
# and % of Patients Showing Complete Response:
5 / 25% – Patients with Newly Diagnosed ANAPLASTIC ASTROCYTOMA (AA)
16% – RECURRENT Anaplastic Astrocytoma (AA)
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ
Interim Reports on Clinical Trials:
ᅵ
12. 12/2008
ᅵ
(BT-8 – PATIENTS WITH ANAPLASTIC ASTROCYTOMA)
ᅵ
(BT-15 – ADULT PATIENTS WITH ANAPLASTIC ASTROCYTOMA)
ᅵ
Phase II study of antineoplastons A10 and AS2-1 infusions (ANP) in PATIENTS WITH recurrent ANAPLASTIC ASTROCYTOMA
http://www.burzynskiclinic.com/images/stories/Publications/7898.pdf
Neuro-Oncology 2008; 10:1067
Volume 10 Issue 6 December 2008
Abstracts for the Eighth Congress of the European Association for Neuro-Oncology (EANO), Sept. 12-14, 2008, Barcelona, Spain
ᅵ
20 / 100% – tumor reoccurred in after radiation therapy
11 / 55% – received additional chemotherapy therapy before recurrence
ᅵ
6.5 months – Median duration of treatment
ᅵ
FDA-monitored phase II clinical trial
ᅵ
12/2008 – Protocol – ADULTS WITH recurrent ANAPLASTIC ASTROCYTOMA (AA)
ᅵ
20 – Evaluable Assessable Adult Patients
(20 – 51 years / 41 – Median age)
ᅵ
3 / 15% – # and % of Patients Showing Complete Response
2 / 10% – # and % of Patients Showing Partial Response
9 / 45% – # and % of Patients Showing Stable Disease
6 / 30% – # and % of Patients Showing Progressive Disease
5 / 25% – # and % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ
Case Reports:
ᅵ
1. 12/2009
ᅵ
BT-11 special exception (SE)
ᅵ
BRAIN STEM GLIOMA
ᅵ
Over a 10-year survival and complete response of a patient with diffuse intrinsic BRAINSTEM GLIOMA (DBSG) treated with antineoplastons (ANP).
Neuro-Oncology 2009; 11:923.
http://www.burzynskiclinic.com/images/stories/Publications/8638.pdf
Volume 11 Issue 6 December 2009
Abstracts from the Third Quadrennial Meeting of the World Federation of Neuro-Oncology (WFNO) and the Sixth Meeting of the Asian Society for Neuro-Oncology (ASNO)
May 11-14, 2009
Yokohama, Japan
ᅵ
8/12/1998 – 6 week old female Caucasian infant – diagnosed with diffuse intrinsic brain stem glioma (DBSG)
ᅵ
Tumor inoperable and pediatric oncology felt chemotherapy as well as radiation therapy wouldn’t be an option considering potential toxicity and age of patient
ᅵ
10/14/1998 – began IV antineoplaston (ANP) under FDA BT-11 special exception (SE)
ᅵ
2/1999 – achieved complete response (CR)
ᅵ
7/8/2000 – converted to oral (PO) antineoplaston (ANP)
ᅵ
7/8/2004 – permanently discontinued antineoplaston (ANP)
ᅵ
11/2008 – 10.5 years old: father stated that clinically she was doing very well
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ
Interim Reports on Clinial Trials:
ᅵ
13. 12/2009 (DBSG)
ᅵ
BT-11 – BRAIN STEM GLIOMA
ᅵ
Special exception (SE)
ᅵ
Phase II study of antineoplastons A10 and AS2-1 in patients with BRAINSTEM GLIOMA. Protocol BC-BT-11.
Neuro-Oncology 2009, 11:951.
http://www.burzynskiclinic.com/images/stories/Publications/8639.pdf
Volume 11 Issue 6 December 2009
Abstracts from the Third Quadrennial Meeting of the World Federation of Neuro-Oncology (WFNO) and the Sixth Meeting of the Asian Society for Neuro-Oncology (ASNO)
May 11-14, 2009
Yokohama, Japan
ᅵ
28 evaluable (ST) (23 children / 5 young adults)
ᅵ
12 – newly diagnosed
16 – previously treated
ᅵ
Additional 52 evaluable
(40 children / 12 young adults)
treated under special exception (SE)
ᅵ
18 – newly diagnosed
ᅵ
BT-11 and special exception (SE)
92% – diffuse intrinsic brainstem gliomas (DBSG)
ᅵ
Treatment median duration:
5.6 months – special exception (SE)
5.4 months – BT-11
ᅵ
12/2009 – Protocol – BRAINSTEM GLIOMAs
ᅵ
40 – Patients Accrued
(12 not evaluable due to short duration of treatment and lack of follow-up MRIs)
28 – Evaluable Patients
ᅵ
5 / 18% – # and % of Patients Showing Complete Response
4 / 14% – # and % of Patients Showing Partial Response
12 / 43% – # and % of Patients Showing Stable Disease
7 / 25% – # and % of Patients Showing Progressive Disease
9 / 32% – # and % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
——————————————————————
Special exception (SE)
ᅵ
12/2009 – Protocol – BRAINSTEM GLIOMAs
ᅵ
52 – Evaluable Patients
ᅵ
5 / 10% – # and % of Patients Showing Complete Response
2 / 4% – # and % of Patients Showing Partial Response
28 / 54% – # and % of Patients Showing Stable Disease
17 / 32% – # and % of Patients Showing Progressive Disease
7 / 14% – # and % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
======================================
COMPARE: standard radiation therapy in combination with chemotherapy (RAT) (Mandell et al. 1999) (6/1992 – 10/1997)
ᅵ
2% – % of Patients Showing Complete Response
31% – % of Patients Showing Partial Response
33% – % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
======================================
COMPARE COMBINED (2):
======================================
# and % of Patients Showing Complete Response
——————————————————————
5 / 18% – Antineoplastons
ᅵ
2% – Mandell et al. 1999 (6/1992 – 10/1997)
——————————————————————
# and % of Patients Showing Partial Response
——————————————————————
4 / 14% – Antineoplastons
ᅵ
31% – Mandell et al. 1999 (6/1992 – 10/1997)
——————————————————————
# and % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
——————————————————————
9 / 32% – Antineoplastons

ᅵ
33% – Mandell et al. 1999 (6/1992 – 10/1997)
======================================
COMPARE COMBINED (3):
======================================
# and % of Patients Showing Complete Response
——————————————————————
5 / 18% – Antineoplastons
ᅵ
5 / 10% – Antineoplastons: Special exception (SE)
ᅵ
10 / 12.5% – COMBINED: Antineoplastons: Special exception (SE)
ᅵ
2% – Mandell et al. 1999 (6/1992 – 10/1997)
——————————————————————
# and % of Patients Showing Partial Response
——————————————————————
4 / 14% – Antineoplastons
ᅵ
2 / 4% – Antineoplastons: Special exception (SE)
ᅵ
6 / 7.5% – COMBINED: Antineoplastons: Special exception (SE)
ᅵ
31% – Mandell et al. 1999 (6/1992 – 10/1997)
——————————————————————
# and % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
——————————————————————
9 / 32% – Antineoplastons
ᅵ
7 / 14% – Antineoplaston: Special exception (SE)
ᅵ
16 / 20% – COMBINED: Antineoplastons: Special exception (SE)
ᅵ
33% – Mandell et al. 1999 (6/1992 – 10/1997)
——————————————————————
Mandell LR, Kadota R, Freeman C, et al. There is no role for hyperfractionated radiotherapy in the management of children with newly diagnosed diffuse intrinsic brain stem tumors: results of pediatric oncology group phase III trial comparing conventional vs. hyperfractionated radiotherapy. Int J Radiat Oncol Biol Phys. 1999;43:959-964.
http://www.ncbi.nlm.nih.gov/pubmed/10192340/
Int J Radiat Oncol Biol Phys. 1999 Mar 15;43(5):959-64.
http://www.ncbi.nlm.nih.gov/m/pubmed/10192340/
International Journal of Radiation Oncology*Biology*Physics
Volume 43, Issue 5, 15 March 1999, Pages 959–964
http://www.sciencedirect.com/science/article/pii/S036030169800501X
Department of Radiation Oncology, Mount Sinai Medical Center, New York, NY, USA.
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ
Interim Reports on Clinical Trials:
ᅵ
14. 6/2010
ᅵ
BT-13 – CHILDREN WITH LOW GRADE ASTROCYTOMA
ᅵ
A Phase II Study of Antineoplaston A-10 and AS-1 Injections in CHILDREN WITH LOW-GRADE ASTROCYTOMAs.
http://www.burzynskiclinic.com/images/stories/Publications/8397.pdf
Neuro-Oncology 2010; 12, ii95.
Volume 12 Issue 6 June 2010
ᅵ
9 / 53% – multicentric disease
ᅵ
9 / 53% – recurrent and / or persistent tumors after chemotherapy
(8 / 47% of 9 had surgery prior to chemotherapy)
{2 / 12% had radiation after chemotherapy}
5 / 29% – recurrent and / or persistent tumors after surgery
3 / 18% – untreated aggressive tumors
ᅵ
17 / 100% – Evaluable for Safety
ᅵ
12 or more weeks or at least 4 weeks of Antineoplastons (ANP) but developed Progressive Disease (PD)
Patients Evaluable for Efficacy
ᅵ
83 weeks – Median Antineoplastons (ANP) (15 / 100% – Evaluable Patients)
ᅵ
6/2010 – Protocol – CHILDREN WITH Recurrent and / or Progressive LOW-GRADE ASTROCYTOMA (LGA)
ᅵ
17 Patients Accrued
(20 months {1 year 8 months} – 210 months {17 years 6 months} / 129 months {10 years 9 months} – Median age)
15 Evaluable Patients
ᅵ
6 / 40% – # and % of Patients Showing Complete Response
1 / 7% – # and % of Patients Showing Partial Response
5 / 33% – # and % of Patients Showing Stable Disease (47 – 85 days / 60 – Median days of Antineoplastons (ANP))
3 / 20% – # and % of Patients Showing Progressive Disease (47 – 85 days / 60 – Median days of Antineoplastons (ANP))
7 / 47% – # and % of Patients Showing Objective Response
ᅵ
Objective response = complete response and partial response
ᅵ
12 / 80% – resolving or stabilizing disease
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ
Interim Reports on Clinical Trials:
ᅵ
15. 11/2010
ᅵ
BT-18 – ADULT PATIENTS WITH MIXED GLIOMA
ᅵ
Preliminary Results of a Phase II Study of Antineoplastons A10 and AS2-1 (ANP) in ADULT PATIENTS WITH Recurrent MIXED GLIOMAs.
http://www.burzynskiclinic.com/images/stories/Publications/8637.pdf
Neuro-Oncology 2010; 12:iv72.
Volume 12 Supplement 4 November 2010
ᅵ
19 / 95% – chemotherapy, radiation therapy, and surgery
1 / 5% – no chemotherapy or radiation therapy post surgery
ᅵ
12 / 92% – high-grade mixed gliomas
1 / 8% – low-grade mixed glioma
ᅵ
7 / 35% – not evaluated due to inadequate duration of treatment and lack of follow-up Magnetic Resonance Imaging (MRI) scans
ᅵ
4.4 months – median duration of treatment
ᅵ
11/2010 – Protocol – ADULT PATIENTS WITH Recurrent MIXED GLIOMAs
ᅵ
20 – Children Patients Accrued
13 – Evaluable Patients
(9 men / 4 women: 29 – 54 years / 38 – Median age)
ᅵ
3 / 23% – # and % of Patients Showing Complete Response
1 / 8% – # and % of Patients Showing Partial Response
3 / 23% – # and % of Patients Showing Stable Disease
6 / 46% – # and % of Patients Showing Progressive Disease
4 / 31% – # and % of Patients Showing Objective Response
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Objective response = complete response and partial response
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7 / 54% – Effective in Resolving or Stabilizing Disease
ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ ᅵ