WHAT IS MISDIRECTION? Critiquing “Antineoplastons: Has the FDA kept its promise to the American people ?”

March 29, 1996

Then United States Food and Drug Administration Commissioner, David Kessler told the American people:

1. We will eliminate unnecessary paperwork … that used to delay or discourage … cancer research … by non-commercial clinical investigators

2. The … FDA’s initiatives … will allow …the agency … to rely on smaller trialsfewer patients … if there is evidence … of partial response in clinical trials

I don’t want to get into any particular … agent … except let me point out … that … the information needs to be part … of clinical trials

3. We will accept … less informationup front

4. we’re going to require further study AFTERapproval … because the science … has matured

5. The important – point … is that information needs to be gathered … through scientific means … through clinical – trials … and I think – that’s … that’s very important uhh very … important point

You can’t … just … use an agent here – or there … you have to use it … as part of a clinical trial … so we can get information … on whether the drug works

6. The uhh agency has … many … trials … has has approved trials … for patients … with antineoplastons

7. We are committed to providing expanded access … availability … for American patients for any drug … there’s reason to believe … may work
——————————————————————
BOTTOM LINE:
——————————————————————
Everything else is MISDIRECTION
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/22/antineoplastons-has-the-fda-kept-its-promise-to-the-american-people
——————————————————————
A. What is the FDA’s definition of “unnecessary paperwork”?

B. What is the FDA’s definition of “smaller trials”?

C. What is the FDA’s definition of “fewer patients”?

D. What is the FDA’s definition of “evidence … of partial response“?

E. What is the FDA’s definition of “less information … up front”?

F. What is the FDA’s definition of “we’re going to require further study AFTER … approval”?

G. What is the FDA’s definition of “We are committed to providing expanded access … availability … for American patients for any drug … there’s reason to believe … may work”?
======================================
2003 – 2009 Phase II preliminary
——————————————————————
2003 – Phase II
http://www.ncbi.nlm.nih.gov/m/pubmed/12718563
Drugs R D. 2003;4(2):91-101
(Drugs in R and D / Drugs in Research and Development)

2003: Protocol – recurrent diffuse intrinsic brain stem glioma

12 – Patients Accrued
10 – Evaluable Patients

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
======================================
http://www.burzynskiclinic.com/scientific-publications.html
Interim Reports on Clinial Trials:

1. 10/2003

NEURO-ONCOLOGY

Burzynski, S.R., Weaver, R.A., Bestak, M., Lewy, R.I., Janicki, T.J., Jurida, G.F., Paszkowiak, J.K., Szymkowski, B.G., Khan, M.I.

Phase II study of Antineoplastons A10 and AS2-1 (ANP) in children with recurrent and progressive MULTICENTRIC GLIOMA

A preliminary report
http://www.burzynskiclinic.com/images/stories/Publications/970.pdf
Neuro-Oncology. 2003; 5: 358
Volume 5 Issue 4 October 2003

10/2003 – Protocol – MULTICENTRIC GLIOMA

12 – Children Patients Accrued
10 – Evaluable Patients
(9 months-17 years / 9 – median age)

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
======================================
Interim Reports on Clinial Trials:

16. 2003

DRUGS IN R&D
Drugs in R and D
(Drugs in Research and Development)

BT-11
BRAIN STEM GLIOMA

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
Burzynski, S.R., Lewy, R.I., Weaver, R.A., Axler, M.L., Janicki, T.J., Jurida, G.F., Paszkowiak, J.K., Szymkowski, B.G., Khan, M.I., Bestak, M.
http://www.ncbi.nlm.nih.gov/m/pubmed/12718563
Drugs R D. 2003;4(2):91-101
Drugs in R&D 2003;4:91-101
http://www.burzynskiclinic.com/images/stories/Publications/960.pdf

Pgs. 91-92 and 95

3/1996 – Protocol – recurrent diffuse intrinsic BRAIN STEM GLIOMA (3/1996 – 5/1999 enrolled / Pg. 94)

12 – Patients Accrued (6 males / 6 females)
(4-29 years / 10 – median age)
10 – Evaluable Patients

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
======================================
2004 – Phase II
http://www.ncbi.nlm.nih.gov/m/pubmed/15563234
Drugs R D. 2004;5(6):315-26
(Drugs in R and D / Drugs in Research and Development)

2004: Protocol – incurable recurrent and progressive multicentric glioma

12 – Patients Accrued
(9 – median age)
11 – Evaluable Patients

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
======================================
Interim Reports on Clinial Trials:

2. 10/2004

NEURO-ONCOLOGY

BT-20
Patients With GLIOBLASTOMA MULTIFORME (GBM)

Weaver, R.A., Burzynski, S.R., Bestak, M., Lewy, R.I., Janicki, T.J., Szymkowski, B., Jurida, G., Khan, M.I., Dolgopolov, V.

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

Pg. 385

10/2004 – Protocol – glioblastoma multiforme (GBM) which recurred or progressed post surgery, radiation therapy, and / or chemotherapy

22 – Evaluable Patients
(6 men / 16 women / 27-63 /47 – median age)

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
======================================
Interim Reports on Clinial Trials:

3. 10/2004 (DBSG)

NEURO-ONCOLOGY

Burzynski, S.R., Weaver, R. Bestak. M., Lewy, R.I., Janicki, T., Jurida, G., Szymkowski, B., Khan, M., Dolgopolov, V.

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

60 patients
(31 didn’t meet admission criteria to the study and were treated under Special Exception (SE))

10/2004 – Protocol – patients with diffuse intrinsic BRAIN STEM GLIOMA (DBSG)

29 – Evaluable Patients

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
——————————————————————
31 – Evaluable Patients: Special exception (SE)

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
======================================
Interim Reports on Clinial Trials:

4. 10/2004 (AT/RT of CNS)

NEURO-ONCOLOGY

BT-14

CHILDREN WITH RHABDOID TUMOR OF THE CENTRAL NERVOUS SYSTEM

Burzynski, S.R., Weaver, R. Bestak. M., Janicki, T., Jurida, G., Szymkowski, B., Khan, M., Dolgopolov, V.

Phase II studies of antineoplastons A10 and AS2-1 (ANP) in children with atypical teratoid/rhabdoid tumors (AT/RT) of the central nervous system

A preliminary report
http://www.burzynskiclinic.com/images/stories/Publications/1146.pdf
Neuro-Oncology. 2004; 6: 427
Volume 6 Issue 4 October 2004
Abstracts from the Eleventh International Symposium on Pediatric Neuro-Oncology, Boston, Massachusetts, June 13-16, 2004

10/2004 – Protocol – children with atypical teratoid / rhabdoid tumors (AT / RT) of the central nervous system

11 – Children Patients Accrued
8 – Evaluable Patients
(7 treated under Special Exception (SE))

2 / 25% – # and % of Patients Showing Complete Response
1 / 12.5% – # and % of Patients Showing Partial Response
1 / 12.5% – # and % of Patients Showing Stable Disease
4 / 50% – # and % of Patients Showing Progressive Disease
======================================
Interim Reports on Clinial Trials:

5. 10/2004

NEURO-ONCOLOGY

BT-12

CHILDREN WITH PRIMITIVE NEUROECTODERMAL TUMORS (PNET)

Burzynski, S.R., Weaver, R. Bestak. M., Janicki, T., Szymkowski, B., Jurida, G., Khan, M., Dolgopolov, V.

Treatment of PRIMITIVE NEUROECTODERMAL TUMORS (PNET) with antineoplastons A10 and AS2-1 (ANP)

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

10/2004 – Protocol – PRIMITIVE NEUROECTODERMAL TUMORS (PNET)

17 – Patients Accrued
15 – Evaluable Patients
(12 months – 23 years / 6 – median age)

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
======================================
Interim Reports on Clinial Trials:

17. 2004

DRUGS IN R&D
Drugs in R and D
(Drugs in Research and Development)

Burzynski, S.R., Weaver, R., Lewy, R., Janicki, T. Jurida, G., Szymkowski, B., Khan, M., Bestak, M.

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):315-326.
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

incurable recurrent and progressive multicentric glioma

Pg. 320

3 – treated under Special Exception (SE) granted by the US FDA

Pgs. 317 and 320

7/31/1996 – (7/31/1996 – 4/3/2002 as of 3/1/2004) Protocol – children with recurrent and progressive multicentric glioma (MCG)

Pg. 317

BT-13

children with low-grade astrocytoma

BT-23

children with visual pathway gliomas


Pgs. 317 and 320-321

12 – Children Patients Accrued (Pgs. 315-316)
(9 months – 17 years / 9- median age)
(6 – male / 6 – females)
10 – Evaluable Patients (Pg. 315)

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
——————————————————————
Pg. 325

Compare: Chamberlain and Grafe. [38]

1995 – Protocol – solitary recurrent chiasmatic hypothalamic gliomas treated with oral etoposide


14 – Patients Accrued
14 – Evaluable Patients

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

Pg. 326

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]

10/2000 – Protocol – solitary progressive optic pathway tumors with carboplatin

50 – Patients Accrued
50 – Evaluable Patients

2 / 4% – # and % of Patients Showing Partial Response
37 / 74% – # and % of Patients Showing Stable Disease
11 / 22% – # and % of Patients Showing Progressive Disease

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/

http://neuro-oncology.oxfordjournals.org/content/2/4/213.full.pdf
======================================
2005 – Phase II
http://www.ncbi.nlm.nih.gov/m/pubmed/15911929
Integr Cancer Ther. 2005 Jun;4(2):168-77
(Integrative Cancer Therapies)

2005: Protocol – recurrent disease or high risk

13 – Patients Accrued
(1-11 – age / 5 years 11 months – median age)
13 – Evaluable Patients

3 / 23% – # and % of Patients Showing Complete Response
1 / 8% – # and % of Patients Showing Partial Response
4 / 31% – # and % of Patients Showing Stable Disease
5 / 38% – # and % of Patients Showing Progressive Disease
——————————————————————
(Updated 2007)
http://www.cancer-therapy.org/CT/v5/B/HTML/42._Burzynski,_379-390.html
2005 – Protocol – incurable recurrent and progressive multicentric glioma

13 – Patients Accrued

3 / 23% – # and % of Patients Showing Complete Response
1 / 8% – # and % of Patients Showing Partial Response
4 / 31% – # and % of Patients Showing Stable Disease
5 / 38% – # and % of Patients Showing Progressive Disease
======================================
2006 – Phase II
http://www.ncbi.nlm.nih.gov/m/pubmed/16484713
Integr Cancer Ther. 2006 Mar;5(1):40-7
(Integrative Cancer Therapies)

2006: Protocol – high-grade pathology (HBSG)

– Patients Accrued
18 – Evaluable Patients

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
======================================
Interim Reports on Clinial Trials:

BT-03


BT-11

BRAIN STEM GLIOMA (BSG)

BT-18

6. MIXED GLIOMA

ADULT PATIENTS WITH MIXED GLIOMA

“mixed glioma”, a type of primary malignant brain tumor (PMBT)

BT-22

8. CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS

CAN-01 (CAN-1)

PATIENTS WITH REFRACTORY MALIGNANCIES

19. 3/2006

Burzynski, S.R., Janicki, T.J., Weaver, R.A., Burzynski, B. 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

http://m.ict.sagepub.com/content/5/1/40.long?view=long&pmid=16484713
Pgs. 40-41

4 phase 2 trials

BRAINSTEM GLIOMA (BSG)

patients with inoperable tumor of high-grade pathology (HBSG)
glioblastoma

recurrent diffuse intrinsic glioblastomas and ANAPLASTIC ASTROCYTOMAs of brainstem

Pg. 43

BT-03 – 1 / female
BT-11 – 13 (8 males/5 females)
BT-18 – 1 / female
BT-22 – 2 / females
CAN-01 – 1 / female

Pg. 44

High-grade, recurrent, and progressive brainstem gliomas

Pgs. 40-42 and 44-45

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)

18 – Evaluable Patients (Pgs. 40-43)
(8 males / 10 females / 2-42 / 10 – median age / Pgs. 42-43)

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
======================================
Interim Reports on Clinial Trials:

BT-11

BRAIN STEM GLIOMA

8. 10/2006

Burzynski, S.R., Janicki, T.J., Weaver, R.A., Szymkowski, B.G., Khan, M.I., Dolgopolov, V. 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)

Brainstem gliomas and multicentric tumors (MBSG)

10/2006 – Protocol – Brainstem gliomas and multicentric tumors (MBSG)

19 – Evaluable Patients
3.9 – 40.8 years (9.2 – median age)
(90% less than 18 years old)

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
======================================
2007
http://www.burzynskiclinic.com/images/stories/Publications/1252.pdf
2004 – Protocol – small group of patients with progressive LGA, ANP
60% – % of Patients Showing Complete Response
10% – % of Patients Showing Partial Response
——————————————————————
2004 – Protocol – low-grade astrocytoma in children
Burzynski [39] – Reference
Phase II d – d = Preliminary results – Study type
P – P = progressive tumor – Tumor type
(no. of pts) – pts = patients
ANP (10) – ANP = antineoplastons A10 and AS2-1 – Treatment
10 – Evaluable Patients {(78) = most in a study}
OS [%] – OS = overall survival
100% (1 yr) – 90% (3 yr) – Efficacy
93 mo – MST = MST = median survival time – {96 (1 y) next closest}
60% (6) – % and # of Patients Showing Complete Response {24 (11) next closest}
10% (1) – % and # of Patients Showing Partial Response {60% (9) best other study}
30% (3) – % and # of Patients Showing Stable Disease + MR = minor response {70% (14) best other study}
0% (0) – % and # of Patients Showing Progressive Disease {4% (2) next closest}
PFS (%)
90 (1 y) – 90 (3 y) – PFS = progression-free survival {100 (1 y) – 68 (3 y) best other study
——————————————————————
2004 – Protocol – diffuse, intrinsic brainstem glioma in children
Burzynski et al. [88] – Reference
Phase II – Study Type
(no. of pts) – pts = patients
RP (30) – RP = recurrent and progressive tumor – Tumor type
30 – Evaluable Patients
ANP – ANP = antineoplastons A10 and AS2-1 – Treatment – ANP
OS (%) – OS = overall survival
[2y; 5y]
46.7; 30 – Efficacy
MST (mo)
19.9 – MST = median survival time
27% (8) – % and # of Patients Showing Complete Response
20% (6) – % and # of Patients Showing Partial Response
23% (7) – % and # of Patients Showing Stable Disease
30% (9) – % and # of Patients Showing Progressive Disease
——————————————————————
Burzynski et al. [89] – Reference
Phase II – Study Type
(no. of pts) – pts = patients
RPS (10) – RPS = recurrent and progressive tumors in children aged <4y – Tumor type {(66) = most in a study}
ANP – ANP = antineoplastons A10 and AS2-1 – Treatment – ANP
OS (%) – OS = overall survival
[2y; 5y] – Efficacy
60; 20 {46.7 (30) = next best study}
MST (mo)
26.3 – MST = median survival time – {19.9 = next best study}
[% (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}
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Interim Reports on Clinial Trials:

BT-11

BRAIN STEM GLIOMA

9. 4/2007 (NDBSG)

Burzynski, S.R., Weaver, R.A., Janicki, T.J., Jurida, G.F., Szymkowski, B.G., Kubove, E. 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

4/2007 – Protocol – newly diagnosed diffuse, intrinsic BRAINSTEM GLIOMAs (NDBSG)

20 – Evaluable assessable children Patients
(3 months-20 years – age)

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
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Interim Reports on Clinial Trials:

BT-11

BRAIN STEM GLIOMA

Special exception (SE)

13. 12/2009 (DBSG)

Burzynski, S.R., Janicki, T.J., Weaver, R.A., Szymkowski, B., Burzynski, G.S. 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

12/2009 – Protocol – BRAINSTEM GLIOMAs

40 – Patients Accrued
28 – Evaluable Patients
(23 children / 5 young adults)

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
——————————————————————
Special exception (SE)

12/2009 – Protocol – BRAINSTEM GLIOMAs

52 – Evaluable Patients
(40 children / 12 young adults)

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
——————————————————————
BT-11 and special exception (SE)
92% – diffuse intrinsic brainstem gliomas (DBSG)

Overall survival (OS) – 2 years:
42% – special exception (SE)
36% – BT-11

Overall survival (OS) – 5 years:
19% – special exception (SE)
25% – BT-11
======================================
Compare: standard radiation therapy in combination with chemotherapy (RAT) (Mandell et al. 1999)

2% – % of Patients Showing Complete Response
31% – % of Patients Showing Partial Response

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.
6/1992 – 10/1997

Overall survival (OS):
7% – 2 years
0% – 5 years
=====================================
COMBINED:
——————————————————————
Overall survival (OS) – 2 years:
——————————————————————
42% – antineoplastons: special exception (SE)

36% – antineoplastons: BT-11

7% – standard radiation therapy in combination with chemotherapy (RAT)
——————————————————————
Overall survival (OS) – 5 years:
——————————————————————
25% – antineoplastons: BT-11

19% – antineoplastons: special exception (SE)

0% – standard radiation therapy in combination with chemotherapy (RAT)
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Break The Walls Down:

——————————————————————
And “THAT’s The BOTTOM LINE”
Because Stone Cold Said So

——————————————————————
IT’s GO TIME
Time To Play The Game:

——————————————————————
Break The Walls Down:

=====================================

Critiquing the Critics on Orac’s Respectful Insolence blog: Part I

Burzynski: Cancer is Serious Business, Part II

#2 – JackM – March 14

“You’re a cancer surgeon who just blogged a 15 page “movie review””

#3 – Mark McA – March 14

“Never understood why Burzliebers don’t question the ‘suppressed research’ gambit

As tho Burz has no possible way to publish his 35 years of what must be conclusive data

You know, like On The Internet For All To See”

This critic obviously did NOT read:

2/24/2013
http://www.skeptical.gb.net/blog/?p=1442

2/27/2013
http://www.skeptical.gb.net/blog/?p=1798

3/9/2013
http://www.thetwentyfirstfloor.com/?p=8001

#5 – elburto – March 14

“Nice work by Skeptic Mule Brian, especially the question about funding”
http://www.randi.org/site/index.php/swift-blog/2050-qburzynski-iiq-is-more-of-the-same.html

If you think THAT was “Nice work,” you obviously did NOT read THIS:

About the Director – Eric Merola
http://www.burzynskimovie.com/index.php?option=com_content&view=article&id=64

“maxed out his credit cards”

“Against all odds, he managed to direct and produce the story of Dr. Burzynski and his patients—without
a dime of outside funding”

How difficult would it have been for Brian Thompson (James Randi Educational Foundation – jref) to find this ?

And the critic continues:

“WRT the Evil! Big! Pharma! rushed-through and deadly drugs of dangerousness, Temodar and Avastin, Count Stan can’t be too opposed to their existence”

Another critic other than Orac who could NOT find:

Temodar:
http://www.pharmainfo.net/fda-articles/fda-safety-page-fatal-medication-errors-associated-temodar

http://www.drugcite.com/?q=TEMODAR

http://www.adverseevents.com/drugdetail.php?AEDrugID=1794&BrandName=TEMODAR

“I’m sure they’ve featured in his close your eyes and pick the names of four chemotherapeutic agents out of a hat PGTCT regimens”

The critic does what critics do best:

“SPECULATE”

“So the vast amounts of moolah he charges for his pick’n’mix blastathon would make him a pharma shill, no?”

You do know FDA required ?

” … in 1997, his medical practice was expanded to include traditional cancer treatment options such as

chemotherapy,

gene targeted therapy,

immunotherapy and

hormonal therapy

in response to FDA requirements that cancer patients utilize more traditional cancer treatment options in order to be eligible to participate in the Company’s

Antineoplaston CLINICAL TRIALS
http://www.sec.gov/Archives/edgar/data/724445/000091205702038660/a2091272z10qsb.txt

#6 – Bob G Los Angeles – March 14

“I seriously doubt that the true believers are likely to be cured of their ailment, but I think it’s useful to offer the counter-arguments so that more or less normal people who don’t happen to have medical training will at least be exposed to the more reason based positions

I agree that it’s a horrible thing when deluded parents cause their children with treatable conditions to die (or to die painfully and prematurely

We don’t seem to have solved this question yet as a civilization”

Maybe this is another critic who thinks that all Burzynski’s successes are due to:

Immunity over inability:

The spontaneous regression of cancer
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3312698
J Nat Sci Biol Med. 2011 Jan-Jun; 2(1): 43–49.
doi: 10.4103/0976-9668.82318
PMCID: PMC3312698

Maybe they should look at THIS:

#7 My 1st-hand Review of Orac’s 2nd-Hand Review – Burzynski: Cancer is Serious Business, Part II | Didymus Judas Thomas’ Hipocritical Oath Blog

March 14, 2013
https://stanislawrajmundburzynski.wordpress.com/2013/03/14/my-1st-hand-review-of-oracs-2nd-hand-review-burzynski-cancer-is-serious-business-part-ii
[…]
http://scienceblogs.com/insolence/2013/03/14/five-things-i-learned-second-hand-from-the-recent-scree…
[…]

#9 – Graham – March 14

“Cancer quacks should in my opinion be held fully responsible for the misery they cause

Those who support them Merola, Mercola & Oz, et al should be held fully responsible for this misery as they are the ones who are really laughing at the deaths of the cancer patients they steer to parasites like Burzynski”

Yeah, chemotherapy and radiation and radiotherapy NEVER caused the death of anyone, I’m sure

#12 – Science Mom – March 14

“I suspect Merola didn’t name names because he made potentially libellous statements about Burzyski’s detractors”

Maybe you shouldn’t “count your chickens before they hatch”

There is a web-site where documents show up related to the movie:
http://www.burzynskimovie.com

“Riiiight

Which is exactly why they have to churn out infomercials, send sleazy attack Shih tzus after Burzynski critics, and whine about all of their persecution whilst refusing to publish studies

Interesting definition of winning”

Do you really want to see who engages in adolescent name-calling, misinformation, disinformation, and misdirection like:

“trolls,” “spammers,” “disingenuous,” “dishonest,” “profoundly dishonest,” “sheer stubborn stupid,” “stupid,” “spambot,” “fools,” “shills, “conman”

Burzynski critics ?
https://www.facebook.com/questions/488444654552853/?refid=17

#16 – Eric Lund – March 14

“The trackback at #7, by the way, is from a site called”

“stanislawrajmundburzynski.wordpress.com”

“So I’d say Orac’s needling is getting to Burzynski, or at least his minions”

Laughable, considering Orac’s and some other Critic’s inability to “Fact-Check”

#17 – Krebiozen – March 14

“Eric Lund,

The trackback at #7, by the way, is from a site called”

“stanislawrajmundburzynski.wordpress.com”

“That’s the blog belonging to DJT, or Squidymus as I prefer to call him, on account of his habit of emitting great clouds of irrelevant verbiage in an attempt to hide his cluelessness when under threat

His incoherence appears to be evolving into even more complete illegibility, if that is possible”

Posts the person who can wend their way through Orac’s “15 page movie review,” but whines about my review of a substantially less amount of pages

#19 – Mu – March 14

“The odd part is, even after 30 years or so of ANP therapy there doesn’t seem to be (or otherwise he/she would surely been in the movie) any patient who was actually cured and is still alive after a significant time

All the people mentioned are either dead or still undergoing treatment with varying success”

I guess I could ignore THESE like you:
2004 – Phase II

http://www.ncbi.nlm.nih.gov/m/pubmed/15563234
incurable recurrent and progressive multicentric glioma

Drugs R D. 2004;5(6):315-26

10 patients are alive and well from 2 to >14 years post-diagnosis

2005 – Phase II
http://www.ncbi.nlm.nih.gov/m/pubmed/15911929
13 children with recurrent disease or high risk

Integr Cancer Ther. 2005 Jun;4(2):168-77

6 (46%) survived more than 5 years

2006
http://www.ncbi.nlm.nih.gov/m/pubmed/16484713
patients with inoperable tumor of high-grade pathology (HBSG) treated with antineoplastons in 4 phase 2 trials

Integr Cancer Ther. 2006 Mar;5(1):40-7

39% – overall survival at 2 years
22% – overall survival at 5 years

17+ years maximum survival for a patient with anaplastic astrocytoma

5+ years for a patient with glioblastoma

39% – Progression-free survival at 6 months

5+ year survival in recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of the brainstem in a small group of patients

#20 – Ren – March 14

“Wait one minute!

On the one hand, Burzinski can’t/won’t publish because everyone from the government on down is blocking him

On the other, some oncologist in Japan can and will publish?

Which is it?

Either the results get published or they don’t

Why won’t the Japanese researcher just publish Burzinski’s data?

I’m confused

It may be too early for me”

It is too early for you

But you can always read the 3 links I provided above at #3, and THESE:

Randomized Phase II Study of Hepatic Arterial Infusion with or without Antineoplastons as Adjuvant Therapy after Hepatectomy for liver Metastases from Colorectal Cancer

Annals of Oncology 2010;21:viii221
http://www.burzynskiclinic.com/images/stories/Publications/8774.pdf

http://oncologypro.esmo.org/meeting-resources/meeting-abstracts/european-society-for-medical-oncology-esmo-2010/randomized-phase-ii-study-of-hepatic-ar-3558.aspx

http://abstracts.webges.com/viewing/view.php?congress=esmo2010&congress_id=296&publication_id=3558

11. Antineoplaston Therapy Doubles 5-Year Survival Rate Following Curative Resection of Hepatic Mets

(May 27/09)

Positive results were borne from a phase II clinical study of Antineoplaston therapy (ANP therapy) in metastatic colon cancer following curative resection of liver mets

The study was performed in Japan

The study consisted of 65 colon cancer patients who had undergone curative resection of their liver mets and were randomized to one of the following groups:

1. intrahepatic infusion of 5FU

2. intrahepatic infusion of 5FU plus IV ANP therapy given (a) daily for seven days following hepatic
resection, and (b) ANP therapy given orally daily for one year

There was a significant difference in overall survival between the 2 groups, with the 5 year survival rate in the 5FU plus ANP therapy arm being 63% vs. 32% in the 5FU only arm

Recurrence rate also differed for the 2 groups, which were 34% and 69% respectively

Lead investigator claims that ANP therapy may find application not only in the treatment of brain tumors as reported previously, but also in the more common colorectal cancer
http://www.colorectal-cancer.ca/IMG/pdf/CCAC_Research_June_19_2009.pdf

Burzynski updates Scientific Publications page

http://www.burzynskiclinic.com/scientific-publications.html

Randomized Phase II Study of Hepatic Arterial Infusion with or without Antineoplastons as Adjuvant Therapy after Hepatectomy for liver Metastases from Colorectal Cancer

Annals of Oncology 2010;21:viii221

http://www.burzynskiclinic.com/images/stories/Publications/8774.pdf

The preventive effect of antineoplaston AS2-1 on HCC recurrence

Oncology Reports 2002; 10: 391-397

http://www.burzynskiclinic.com/images/stories/Publications/964.pdf

Burzynski: Japan antineoplaston publications

7/20/1988 – Chemopreventive effect of antineoplaston A-10 on urethane-induced pulmonary neoplasm in mice
http://www.ncbi.nlm.nih.gov/m/pubmed/3183462
Tsuda
N E
Nihon Gan Chiryo Gakkai Shi. 1988 Jul.20; 23 (7):1560-5
23(7):1560-5 (1988)
Nihon Gan Chiryo Gakkai Shi

1/20/1990 – A-10 Injection – The anticancer effect of antineoplaston A-10 on human breast cancer serially transplanted to athymic mice
http://www.ncbi.nlm.nih.gov/m/pubmed/2157780
Nihon Gan Chiryo Gakkai Shi. 1990 Jan 20;25(1):1-5
1990 Tsuda (Japan) et al published with The members of Antineoplaston Study Group
Kurume Med J. 1990;37(2):97-104
http://www.ncbi.nlm.nih.gov/pubmed/2175003
Burzynski References: 1 – 8 and 11 – 14
Abstract:
http://www.jstage.jst.go.jp/article/kurumemedj1954/37/2/37_2_97/_article
References:
http://www.jstage.jst.go.jp/article/kurumemedj1954/37/2/37_2_97/_article/references
PDF
http://www.jstage.jst.go.jp/article/kurumemedj1954/37/2/37_2_97/_pdf
5/1992 Tsuda (Japan) publishes re A-10 Injection:
http://www.ncbi.nlm.nih.gov/m/pubmed/1377669
Burzynski References: 1, 4 – 7 and 9
Nishida (Japan) A-10 Reference: 2
Abstract:
http://onlinelibrary.wiley.com/doi/10.1111/j.1349-7006.1992.tb01960.x/abstract
References:
http://onlinelibrary.wiley.com/doi/10.1111/j.1349-7006.1992.tb01960.x/references
PDF
http://onlinelibrary.wiley.com/store/10.1111/j.1349-7006.1992.tb01960.x/asset/j.1349-7006.1992.tb01960.x.pdf?v=1&t=hdcl29bl&s=dd78f02b92e0f5544c136e7b897a7d65bcf5dc71&systemMessage=Wiley+Online+Library+will+be+disrupted+on+23+February+from+10%3A00-12%3A00+BST+%2805%3A00-07%3A00+EDT%29+for+essential+maintenance
5/1995 Tsuda (Japan) publishes re Antineoplaston:
Kurume Med J. 1995;42(3):133-40
http://www.ncbi.nlm.nih.gov/m/pubmed/7474850
Burzynski References: 1 – 2 and 4
Samid Reference: 7 (who learned from Burzynski re Phenylacetate)
Lee (Japan) A-10 Reference: 3
Nishidi (Japan) A-10 Reference: 6
Abstract:
http://www.jstage.jst.go.jp/article/kurumemedj1954/42/3/42_3_133/_article
References:
http://www.jstage.jst.go.jp/article/kurumemedj1954/42/3/42_3_133/_article/references
PDF
http://www.jstage.jst.go.jp/article/kurumemedj1954/42/3/42_3_133/_pdf
1995 Tsuda (Japan) publishes re A-10 and AS2-1:
Kurume Med J. 1995;42(4):241-9
http://www.ncbi.nlm.nih.gov/m/pubmed/8667595
Burzynski References: 1 – 3 and 5
Nishida et al. (Japan) A-10 Reference: 4 and 7
Muldoon et al. A-10 Reference: 6
Abstract:
http://www.jstage.jst.go.jp/article/kurumemedj1954/42/4/42_4_241/_article
References:
http://www.jstage.jst.go.jp/article/kurumemedj1954/42/4/42_4_241/_article/references
PDF
http://www.jstage.jst.go.jp/article/kurumemedj1954/42/4/42_4_241/_pdf
1996 Tsuda (Japan) publishes re A10 and AS2-1:
Kurume Med J. 1996;43(2):137-47
http://www.ncbi.nlm.nih.gov/m/pubmed/8755117
Burzynski References: 1 – 3, 5 and 7
Samid Reference: 13 (who learned from Burzynski re Phenylacetate)
Nishida et al. (Japan) A10 Reference: 4 and 10
Muldoon et al. A10 Reference: 8
Abstract:
http://www.jstage.jst.go.jp/article/kurumemedj1954/43/2/43_2_137/_article
References:
http://www.jstage.jst.go.jp/article/kurumemedj1954/43/2/43_2_137/_article/references
PDF
http://www.jstage.jst.go.jp/article/kurumemedj1954/43/2/43_2_137/_pdf
7 – 8/2007 (Japan) publishes re A10:
http://www.ncbi.nlm.nih.gov/m/pubmed/17695534
Burzynski References: 1, 3, 5, 13 and 15
Badria (Egypt) A-10 References: 2 and 20
Wang A10 Reference: 4
http://ar.iiarjournals.org/content/27/4B/2427.short
Abstract:
http://ar.iiarjournals.org/content/27/4B/2427.long
PDF
http://ar.iiarjournals.org/content/27/4B/2427.full.pdf
1/2008 (Japan) publishes re antineoplaston:
Breast Cancer. 2008;15(1):73-8. doi: 10.1007/s12282-007-0015-y
Breast Cancer: January 2008, Volume 15, Issue 1, pp 73-78
http://www.ncbi.nlm.nih.gov/m/pubmed/18224398
Burzynski Reference: 12
Tsuda (Japan) Antineoplaston Reference: 13
http://link.springer.com/article/10.1007%2Fs12282-007-0015-y

1990 – Inhibitory effect of antineoplaston A-10 on breast cancer transplanted to athymic mice and human hepatocellular carcinoma cell lines
http://www.ncbi.nlm.nih.gov/m/pubmed/2175003
H TSUDA
Kurume University School of Medicine, Japan
Kurume Med J 37 (2):97-104 (1990)
Kurume Medical Journal
J-STAGE, Japan Science and Technology Information Aggregator, Electronic
http://www.jstage.jst.go.jp/article/kurumemedj1954/37/2/37_2_97/_article

http://onlinelibrary.wiley.com/doi/10.1111/j.1349-7006.1992.tb01960.x/abstract

http://ci.nii.ac.jp/naid/130000888719

1991 – Inhibitory effect of orally administered antineoplaston A10 on the growth curve of human breast cancer transplanted to athymic mice
J Jpn Soc Cancer Ther 26:595-601, 1991

1992 – antineoplaston – Prevention of drug induced DNA hypermethylation by antineoplaston components
LIAU M C
Intl J Exp Clin Chemother 1992; 5:19-27
https://data.epo.org/publication-server/pdf-document?PN=EP0680756%20EP%200680756&iDocId=4830495&iepatch=.pdf

http://eng.med.wanfangdata.com.cn/PaperDetail.aspx?qkid=zgzllc-e&qcode=zgzllc-e200504004

http://so.med.wanfangdata.com.cn/ViewHTML/PeriodicalPaper_zgzllc-e200504004.aspx

5/1992 – The inhibitory effect of the combination of antineoplaston A-10 injection with a small dose of cis-diamminedichloroplatinum on cell and tumor growth of human hepatocellular carcinoma
http://www.ncbi.nlm.nih.gov/m/pubmed/1377669
The Inhibitory Effect of the Combination of Antineoplaston A-10 Injection with a Small Dose of cis-Diamminedichloroplatinum on Cell and Tumor Growth of Human Hepatocellular Carcinoma
H TSUDA
Department of Anesthesiology, Kurume University, School of Medicine, Fukuoka-ken
Jpn J Cancer Res. 1992 May;83(5):527-31
Jpn. J. Cancer Res. 83, 527-531
Jpn J Cancer Res. 1992 May;83 (5):527-31
Jpn J Cancer Res 83 (5):527-31 (1992)
Article first published online: 26 AUG 2005
DOI: 10.1111/j.1349-7006.1992.tb01960.x
Japan Journal Cancer Research
http://onlinelibrary.wiley.com/doi/10.1111/j.1349-7006.1992.tb01960.x/abstract

http://onlinelibrary.wiley.com/store/10.1111/j.1349-7006.1992.tb01960.x/asset/j.1349-7006.1992.tb01960.x.pdf?v=1&t=hd97ht7z&s=3481466c7830e5f8e2bb925a698de6f8155da747

http://onlinelibrary.wiley.com/store/10.1111/j.1349-7006.1992.tb01960.x/asset/j.1349-7006.1992.tb01960.x.pdf;jsessionid=4ECD3F595A3971B5AB87763862867844.d03t02?v=1&t=hbmd55gj&s=a14b626a37db3ecd558109cee30dfe26c71827763862867844
Cancer Science
Cancer …, Wiley Online Library
2003 – AS2-1 –
Oncology …,
The preventive effect of antineoplaston AS2-1 on HCC recurrence

1995 – (Clinically tested) – The effect of Antineoplaston, a new antitumor agent on malignant brain tumors
http://www.ncbi.nlm.nih.gov/m/pubmed/7474850
H H TSUDA
Department of Neurosurgery, Kurume University School of Medicine, Japan
Kurume Med J. 1995;42(3):133-40
Kurume Med J 42(3):133-40 (1995)
Kurume Medical Journal
J-STAGE, Japan Science and Technology Information Aggregator, Electronic

1995 – Toxicological study on antineoplastons A-10 and AS2-1 in cancer patients
http://www.ncbi.nlm.nih.gov/m/pubmed/8667595
H Tsuda
Kurume Med J 42 (4):241-9 (1995)
Department of Anesthesiology, Kurume University School of Medicine, Japanu
Kurume Med Journal
J-STAGE, Japan Science and Technology Information Aggregator, Electronic
http://www.jstage.jst.go.jp/article/kurumemedj1954/42/4/42_4_241/_article

http://www.jstage.jst.go.jp/article/kurumemedj1954/42/4/42_4_241/_pdf

1996 – Inhibitory effect of antineoplaston A10 and AS2-1 on human hepatocellular carcinoma
http://www.ncbi.nlm.nih.gov/m/pubmed/8755117
Tsuda H
Department of Anesthesiology, Kurume University School of Medicine, Japan
Kurume Med J 43 (2):137-47 (1996)
J-STAGE, Japan Science and Technology Information Aggregator, Electronic
http://www.jstage.jst.go.jp/article/kurumemedj1954/43/2/43_2_137/_article

http://www.jstage.jst.go.jp/article/kurumemedj1954/43/2/43_2_137/_pdf

11-12/1997 – phase I clinical trial – Antineoplaston AS2-1 for maintenance therapy in liver cancer
http://www.ncbi.nlm.nih.gov/m/pubmed/21590224
H Tsuda
http://www.ncbi.nlm.nih.gov/m/pubmed/21590224
KURUME UNIV,SCH MED,DEPT SURG,KURUME,FUKUOKA,JAPAN. KURUME UNIV,SCH MED,DEPT INTERNAL MED,KURUME,FUKUOKA,JAPAN. KURUME UNIV,SCH MED,DEPT RADIOL,KURUME,FUKUOKA,JAPAN
4 (6):1213-6
Oncol Rep. 1997 Nov-Dec;4(6):1213-6
Oncol Rep. 1997; 4:1213- 1216
Oncol Rep 4 (6):1213-6 (1997)
Oncology Reports
http://www.spandidos-publications.com/or/4/6/1213

5 – 6/1998 – A10 and AS2-1 – I – Quick response of advanced cancer to chemoradiation therapy with antineoplastons
http://www.ncbi.nlm.nih.gov/m/pubmed/9538158
H Tsuda
http://www.ncbi.nlm.nih.gov/m/pubmed/9538158
Department of Anesthesiology, Kurume University, School of Medicine, Kurumeshi, Fukuokaken, Japan
5 (3):597-600
Oncol. Rep. 1998;5:597–600
Oncol Rep. 1998 May-Jun;5 (3):597-600
Oncol Rep 5 (3):597-600 (1998)
Oncology Reports
http://www.spandidos-publications.com/or/5/3/597

11-12/1998 – A10 I – I – Antineoplaston treatment for advanced hepatocellular carcinoma
http://www.ncbi.nlm.nih.gov/m/pubmed/9769368
H Tsuda
Department of Radiology, Kumabe Hospital, Kurume University School of Medicine, Kurumeshi, Fukuokaken, Japan
5 (6):1363-7
Oncol Rep. 1998;5:1363-1367
Oncol Rep. 1998 Nov-Dec;5 (6):1363-7
Oncol Rep 5 (6):1363-7 (1998)
Oncology Reports, Spandidos Publications
http://www.spandidos-publications.com/or/5/6/1363

2002 – Inhibitory effect of antineoplaston A10 and AS2-1 on human hepatocellular carcinoma
H TSUDA
Department of Anesthesiology, Kurume University School of Medicine, Japan
43 (2):137-47 PMID 8755117
J-STAGE, Japan Science and Technology Information Aggregator, Electronic
http://www.jstage.jst.go.jp/article/kurumemedj1954/43/2/43_2_137/_article

http://www.jstage.jst.go.jp/article/kurumemedj1954/43/2/43_2_137/_pdf

2002 – A10 & AS2-1 – A novel strategy for remission induction and maintenance in cancer therapy
http://www.ncbi.nlm.nih.gov/m/pubmed/11748457
H Tsuda
Department of Anesthesiology, Kurume University, School of Medicine, Fukuoka-ken , Japan
mx2.tiki.ne.jp
Oncol Rep 2002;9:65–8
Oncol. Rep. 2002;9:65-68
Oncol Rep 9(1):65-8 (2002)
Oncology Reports, Spandidos Publications
http://www.spandidos-publications.com/or/9/1/65

2002 -The preventive effect of antineoplaston AS2-1 on HCC recurrence
Tsuda
Oncology Reports 2002; 10: 391-397
http://www.burzynskiclinic.com/images/stories/Publications/964.pdf

2003 – Long-term survival following treatment with antineoplastons for colon cancer with unresectable multiple liver metastases: report of a case
http://www.ncbi.nlm.nih.gov/m/pubmed/12768372
TSUDA H
Surg Today 2003
http://www.springerlink.com/content/b48ch3ha165nbrqp

http://sciencelinks.jp/j-east/article/200313/000020031303A0389449.php

http://ci.nii.ac.jp/naid/10015483373

3 – 4/2003 – Phase II Clinical Trial – The preventive effect of antineoplaston AS2-1 on HCC recurrence
http://www.ncbi.nlm.nih.gov/m/pubmed/12579278
Hideaki H TSUDA
Department of Anesthesiology, Kurume Daiichi Social Insurance Hospital, Kushihara Kurumeshi, Fukuoka, Japan
Oncol Rep. 2003 Mar-Apr;10(2):391-7
Oncol Rep 10 (2):391-7 (2003)
Oncol Rep 2003;10:391–7
Oncol Rep. 2003;10:391-397
Oncology Reports
Spandidos Publications
http://www.spandidos-publications.com/or/10/2/391

http://link.springer.com/article/10.1007%2Fs10595-002-2503-2?LI=true

6/2003 – A10 & AS2-1 – Phase II Clinical Trial – Long-Term Survival Following Treatment with Antineoplastons for Colon Cancer with Unresectable Multiple Liver Metastases:
Report of a Case
http://www.ncbi.nlm.nih.gov/m/pubmed/12768372
Hideaki Tsuda
Department of Surgery, Kurume University School of Medicine, Kurume, Fukuoka, Japan
Surg Today. 2003;33(6):448-53
Surg Today 2003; 33:448–53
Surg Today. 2003; 33:448-453
33 (6):448-53
DOI: 10.1007/s10595-002-2503-2
Surgery Today, Springer

http://link.springer.com/article/10.1007%2Fs10595-002-2503-2

http://link.springer.com/article/10.1007%2Fs10595-002-2503-2?LI=true

http://link.springer.com/content/pdf/10.1007%2Fs10595-002-2503-2

http://sciencelinks.jp/j-east/article/200313/000020031303A0389449.php

http://ci.nii.ac.jp/naid/10015483373

9/2003 – [Anti-proliferative effects of biochemical defense modifier antineoplaston in colorectal carcinoma]
http://www.ncbi.nlm.nih.gov/m/pubmed/14574945
Department of Surgery, Kurume University School of Medicine
61 Suppl 7:505-9
Nihon Rinsho (2003)
Nihon Rinsho. 2003 Sep; 61 Suppl 7:505-9 Article in Japanese

2004 -Analysis of cell growth inhibitory effects of antineoplaston through MAPK in human breast cancer cell line SKBR-3
http://www.ncbi.nlm.nih.gov/m/pubmed/14755017
TSUDA
EJC Supplements 2 (3): 2 (2004),
DOI: 10.1016/S1359-6349(04)90794-X
The Oncologist, AlphaMed Press
Complementary and alternative therapies for cancer
http://m.theoncologist.alphamedpress.org/content/9/1/80.short

http://theoncologist.alphamedpress.org

http://m.theoncologist.alphamedpress.org/content/9/1/80.long

http://m.theoncologist.alphamedpress.org/content/9/1/80.full.pdf

http://theoncologist.alphamedpress.org/content/9/1/80.full?sid=09bf7d6b-2d6c-4097-a48d-ef768e65569b

http://theoncologist.alphamedpress.org/content/9/1/80.full.pdf?sid=30deadf2-7850-4ea2-9760-664ceee77eed

http://www.oncocure.ca/assets/byTopic/IntegrativeOncology/2-CAM%20Therapies%20in%20CA-Oncologist%202004.pdf

http://intl-cme.alphamedpress.org/cgi/hierarchy/ampcme_course;91080

http://cme.alphamedpress.org/cgi/hierarchy/ampcme_course;91080

http://www.integratedhealthclinic.com/assets/byTopic/IntegrativeOncology/2-CAM%20Therapies%20in%20CA-Oncologist%202004.pdf

http://theoncologist.alphamedpress.org/content/9/1/80.full?sid=09bf7d6b-2d6c-4097-a48d-ef768e65569b

http://theoncologist.alphamedpress.org/content/9/1/80.full.pdf?sid=30deadf2-7850-4ea2-9760-664ceee77eed

http://www.oncocure.ca/assets/byTopic/IntegrativeOncology/2-CAM%20Therapies%20in%20CA-Oncologist%202004.pdf

http://intl-cme.alphamedpress.org/cgi/hierarchy/ampcme_course;91080

http://cme.alphamedpress.org/cgi/hierarchy/ampcme_course;91080

http://www.integratedhealthclinic.com/assets/byTopic/IntegrativeOncology/2-CAM%20Therapies%20in%20CA-Oncologist%202004.pdf

2005 – Effects of antineoplaston AS2-1 against post-operative lung metastasis in orthotopically implanted colon cancer in nude rat
http://www.ncbi.nlm.nih.gov/m/pubmed/15706406
Tsuda H
Department of Surgery, Kurume University School of Medicine, Kurume City, Fukuoka, Japan
Oncol Rep. 2005 Mar;13(3):389-95
Oncology …,

3/2005 – Effects of antineoplaston AS2-1 against post-operative lung metastasis in orthotopically implanted colon cancer in nude rat
http://www.ncbi.nlm.nih.gov/m/pubmed/15706406
Hideaki TSUDA
Department of Surgery, Kurume University School of Medicine, Kurume City, Fukuoka, Japan
Oncol Rep 13 (3): 389-95 (2005)
Oncol Rep. 2005 Mar; 13 (3):389-95
Oncology Reports, 3/2005, Volume 13 Number 3
Pages: 389-395 Oncology Reports, Spandidos Publications
http://www.spandidos-publications.com/or/13/3/389

8/2005 – Antineoplaston A10 – Antineoplaston induces G1 arrest by PKCα and MAPK pathway in SKBR-3 breast cancer cells
http://www.ncbi.nlm.nih.gov/m/pubmed/16012735
Antineoplaston induces G1 arrest by PKCo and MAPK pathway in SKBR-3 breast cancer cells
Antineoplaston induces G(1) arrest by PKCalpha and MAPK pathway in SKBR-3 breast cancer cells
Hideaki H TSUDA
Department of Surgery, Kurume University School of Medicine, Kurume, Fukuoka, Japan
med.kurume-u.ac.jp
Oncol Rep 14(2):489-94 (2005)
Oncol Rep. 8/2005; 14(2):489-94
Oncology Reports, 8/2005, Volume 14 Number 2
Pages: 489-494
Oncol Rep. 2005; 14:489–94
Oncol. Rep. 14, 489–494
Oncology .Reports, Spandidos Publications
http://www.spandidos-publications.com/or/14/2/489

http://gyouseki.kurume-u.ac.jp/PDF/ichiran_2005.pdf

http://research.kurume-u.ac.jp/K90RES.php?scode=49485632873864

http://onlinelibrary.wiley.com/doi/10.1002/iub.574/abstract

http://onlinelibrary.wiley.com/doi/10.1002/iub.574/full

http://onlinelibrary.wiley.com/store/10.1002/iub.574/asset/574_ftp.pdf?v=1&t=hbr9z60q&s=0b1c1e8655db9c54b45dbf72062e8b11cb7895ac

2006 – Inhibitory Effect of Antineoplaston A10 and AS2-1 on Human Hepatocellular Carcinoma
http://www.ncbi.nlm.nih.gov/m/pubmed/8755117
TSUDA
med.kurume-u.ac.jp
Kurume Medical Journal
http://www.jstage.jst.go.jp/article/kurumemedj1954/43/2/43_2_137/_article

http://www.jstage.jst.go.jp/article/kurumemedj1954/43/2/43_2_137/_pdf

7 – 8/27/2007 – Induction of apoptosis in human hepatocellular carcinoma cells by synthetic antineoplaston A10
http://www.ncbi.nlm.nih.gov/m/pubmed/17695534
Induction of Apoptosis in Human Hepatocellular Carcinoma Cells by Synthetic Antineoplaston A10,
School of Pharmaceutical Sciences, Shandong University, Jinan, Japan
Anticancer Research, Vol. 27, No. 4B, 2007, pp. 2427-2431
Anticancer Res 27(4B):2427-31 (2007)
Anticancer Res. 7 – 8/2007; 27(4B):2427-31
Anticancer Research
International Journal of Cancer Treatment
HighWire Press
http://ar.iiarjournals.org/content/27/4B/2427.short

http://ar.iiarjournals.org/content/27/4B/2427.long

http://ar.iiarjournals.org/content/27/4B/2427.full.pdf

http://www.iiar-anticancer.org/main.php?pid=3398&id=2&ch=52&gch=&volume=27&issue=4B&show=details&page=2

1/2008 – antineoplaston – Preclinical studies of molecular-targeting diagnostic and therapeutic strategies against breast cancer
http://www.ncbi.nlm.nih.gov/m/pubmed/18224398
15(1):73-8
Department of Surgery, Kurume University, Fukuoka, Japan
Breast Cancer 15(1):73-8 (2008)
DOI: 10.1007/s12282-007-0015-y
http://link.springer.com/article/10.1007%2Fs12282-007-0015-y

http://www.springerlink.com/content/p724x34746l56v73

http://ci.nii.ac.jp/naid/10021288533

2010 – Antineoplastons – Japan – Tsuda – Phase II
Randomized Phase II Study of Hepatic Arterial Infusion with or without Antineoplastons as Adjuvant Therapy after Hepatectomy for liver Metastases from Colorectal Cancer

Annals of Oncology 2010;21:viii221
http://www.burzynskiclinic.com/images/stories/Publications/8774.pdf

Randomized Phase II Study of Hepatic Arterial Infusion with or without Antineoplastons as Adjuvant Therapy after Hepatectomy for liver Metastases from Colorectal Cancer
https://stanislawrajmundburzynski.wordpress.com/2013/03/28/burzynski-the-antineoplaston-randomized-japan-phase-ii-clinical-trial-study
Annals of Oncology 2010;21:viii221
http://www.burzynskiclinic.com/images/stories/Publications/8774.pdf

http://oncologypro.esmo.org/meeting-resources/meeting-abstracts/european-society-for-medical-oncology-esmo-2010/randomized-phase-ii-study-of-hepatic-ar-3558.aspx

http://abstracts.webges.com/viewing/view.php?congress=esmo2010&congress_id=296&publication_id=3558
11. Antineoplaston Therapy Doubles 5-Year Survival Rate Following Curative Resection of Hepatic Mets

(May 27/09)

Positive results were borne from a phase II clinical study of Antineoplaston therapy (ANP therapy) in metastatic colon cancer following curative resection of liver mets

The study was performed in Japan

The study consisted of 65 colon cancer patients who had undergone curative resection of their liver mets and were randomized to one of the following groups:

1. intrahepatic infusion of 5FU

2. intrahepatic infusion of 5FU plus IV ANP therapy given (a) daily for seven days following hepatic
resection, and (b) ANP therapy given orally daily for one year

There was a significant difference in overall survival between the 2 groups, with the 5 year survival rate in the 5FU plus ANP therapy arm being 63% vs. 32% in the 5FU only arm

Recurrence rate also differed for the 2 groups, which were 34% and 69% respectively

Lead investigator claims that ANP therapy may find application not only in the treatment of brain tumors as reported previously, but also in the more common colorectal cancer
http://www.colorectal-cancer.ca/IMG/pdf/CCAC_Research_June_19_2009.pdf
Antineoplaston Therapy Doubles 5-Year Survival Rate Following Curative Resection of Hepatic Mets

Randomized Phase II Study of Hepatic Arterial Infusion with or without Antineoplastons as Adjuvant Therapy after Hepatectomy for Liver Metastases from Colorectal Cancer
http://oncologypro.esmo.org/meeting-resources/meeting-abstracts/european-society-for-medical-oncology-esmo-2010/randomized-phase-ii-study-of-hepatic-ar-3558.aspx
Publication date: May 17, 2010
Category: Colorectal cancer
Publisher: ESMO
Y. Ogata; K. Shirouzu; K. Matono; M. Ushijima; S. Uchida; H. Tsuda
http://abstracts.webges.com/viewing/view.php?congress=esmo2010&congress_id=296&publication_id=3558
Abstract: 3558
Congress: ESMO 2010
Type: Publication
Topic: Colorectal cancer
Authors: Y. Ogata, K. Shirouzu, K. Matono, M. Ushijima, S. Uchida, H. Tsuda; Kurume/JP
http://www.biomeddefine.com/sdx/t31/all/100/epithelial+neoplasm+glandular+piperidines+chemical+ingredient.html

http://www.biomeddefine.com/sdx/t31/all/100/ca+secondary+cancer+piperidines+chemical+ingredient.html
Antineoplaston Therapy Doubles Five-Year Survival Rate Following Curative Resection of Hepatic Mets

Metastatic Colon Cancer:

In a Randomized Phase II Clinical Study, Antineoplaston Therapy Doubled the 5-Year Survival Rate Following Curative Resection of Hepatic Metastases
http://www.drugs.com/clinical_trials/metastatic-colon-cancer-randomized-phase-ii-clinical-study-antineoplaston-therapy-doubled-5-year-7307.html
HOUSTON–(BUSINESS WIRE)–May 27, 2009 – The Burzynski Research Institute, Inc.

(BRI) is pleased to announce the results of a randomized Phase II clinical study of antineoplaston therapy (ANP therapy) in metastatic colon cancer following curative resection of hepatic metastases

The study was performed at the Kurume University School of Medicine (Japan) in the Department of Surgery

A report of the study results is currently in press
http://oncologypro.esmo.org/meeting-resources/meeting-abstracts/european-society-for-medical-oncology-esmo-2010/randomized-phase-ii-study-of-hepatic-ar-3558.aspx

http://abstracts.webges.com/viewing/view.php?congress=esmo2010&congress_id=296&publication_id=3558
11. Antineoplaston Therapy Doubles 5-Year Survival Rate Following Curative Resection of Hepatic Mets (May 27/09)
Positive results were borne from a phase II clinical study of Antineoplaston therapy (ANP therapy) in metastatic colon cancer following curative resection of liver mets
study was performed in Japan
study consisted of 65 colon cancer patients who had undergone curative resection of their liver mets and were randomized to one of the following groups:
1. infusion of x
2. infusion of x plus IV ANP therapy
significant difference in overall survival between the 2 groups
5 year survival rate
63% in x plus ANP therapy arm
32% in the x only arm
Recurrence rate for the 2 groups
34%
69%
http://finance.yahoo.com/news/Metastatic-Colon-Cancer-In-a-bw-15355368.html?.v=1

http://www.colorectal-cancer.ca/IMG/pdf/CCAC_Research_June_19_2009.pdf

http://www.colorectal-cancer.ca/IMG/pdf/CCAC_Research_June_19_2009.pdf
Annals of Oncology 2010;21:viii221

http://oncologypro.esmo.org/meeting-resources/meeting-abstracts/european-society-for-medical-oncology-esmo-2010/randomized-phase-ii-study-of-hepatic-ar-3558.aspx

http://abstracts.webges.com/viewing/view.php?congress=esmo2010&congress_id=296&publication_id=3558

http://www.biomeddefine.com/sdx/t31/all/100/epithelial+neoplasm+glandular+piperidines+chemical+ingredient.html

http://www.biomeddefine.com/sdx/t31/all/100/ca+secondary+cancer+piperidines+chemical+ingredient.html

http://www.drugs.com/clinical_trials/metastatic-colon-cancer-randomized-phase-ii-clinical-study-antineoplaston-therapy-doubled-5-year-7307.html