(Being added to)
clinicaltrials . gov does NOT contain the same data as the National Cancer Institute (NCI) at the National Institutes of Health (NIH) cancer . gov web-site:
� � � � � � � � � � � � � � � � �
50 – Unknown
7 – Withdrawn
2 – Terminated
1 – Not yet recruiting
1 – Completed
61 – TOTAL
� � � � � � � � � � � � � � � � �
1 – Not Yet Recruiting (Open)(Phase 3)
1 – Completed
2 – Terminated (Withdrawn due to slow enrollment)
7 – Withdrawn (This study has been withdrawn prior to enrollment)
10 – Recruiting (Open)
11 – Open (1 Not Yet Recruiting / 10 Recruiting)
40 – Active, not recruiting (Closed)
61 – TOTAL
� � � � � � � � � � � � � � � � �
Below 1 st link: 10 Active (Open):
http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11475951
� � � � � � � � � � � � � � � � �
Below 2nd link: 25 Closed-1st screen / 15 Closed-1 Completed-2nd screen:
http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11476036
� � � � � � � � � � � � � � � � �
1 – Completed
2 – Terminated (Withdrawn due to slow enrollment)
7 – Withdrawn (This study has been withdrawn prior to enrollment)
9=WITHDRAWN
1 – Not Yet Recruiting (Open)
10 – Recruiting (Open)
11=OPEN (1 Not Yet Recruiting / 10 Recruiting)
40 – Active, not recruiting (Closed)
61 – TOTAL
� � � � � � � � � � � � � � � � �
1=COMPLETED
9=WITHDRAWN
11=OPEN
40=CLOSED
61-TOTAL
� � � � � � � � � � � � � � � � �
The “one” COMPLETED trial:
The below 2nd link: 25 Closed-1st screen / 15 Closed-1 COMPLETED-2nd screen:
http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11476036
Antineoplaston Therapy in Treating Patients With Stage IV Melanoma
Phase: Phase II
Type: Treatment
Status: COMPLETED
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066552, BC-ME-2, NCT00003509
http://clinicaltrials.gov/ct2/results?term=&recr=Completed&rslt=&type=&cond=&intr=&titles=&outc=&spons=&lead=Burzynski+&id=&state1=&cntry1=&state2=&cntry2=&state3=&cntry3=&locn=&gndr=&phase=1&rcv_s=&rcv_e=&lup_s=&lup_e=
COMPLETED
Antineoplaston Therapy in Treating Patients With Stage IV Melanoma
Condition: Melanoma (Skin)
Interventions:
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
1 study: Melanoma
1 study: Neoplasms, Germ Cell and Embryonal
1 study: Neoplasms, Nerve Tissue
1 study: Neuroectodermal Tumors
1 study: Neuroendocrine Tumors
1 study: Neuroepithelioma
1 study: Nevus
1 study: Nevus, Pigmented
1 study found, shown on map
Region Number of
Name Studies
World 1
North America 1
United States [map] 1 [studies]
Found 1 study with search of:
COMPLETED | Burzynski [Lead] | Phase 2
Recognized Terms and Synonyms:
burzynski: 61 studies
http://clinicaltrials.gov/ct2/show/NCT00003509?recr=Completed&lead=Burzynski&phase=1&rank=1
Trial record 1 of 1 for:
COMPLETED | Burzynski [Lead] | Phase 2
Antineoplaston Therapy in Treating Patients With Stage IV Melanoma
This study has been COMPLETED
Sponsor: Burzynski Research Institute
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003509
11/1/1999 – First received
5/23/2009 – Last updated
5/2009 – Last verified
http://clinicaltrials.gov/ct2/archive/NCT00003509
Securities and Exchange Commission (SEC) filings “one” COMPLETED trial:
Burzynski Clinical Trials (The SEC filings):
https://stanislawrajmundburzynski.wordpress.com/2013/04/11/burzynski-clinical-trials-2/
Certain prospective protocols which have reached a Milestone as of May 1, 2012
Antineoplaston Therapy in Treating Patients With Stage IV Melanomau
Melanoma (Skin)
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
COMPLETED
Age 18 and over
Protocol IDs
CDR0000066552
BC-ME-2, NCT00003509
http://cancer.gov/clinicaltrials/BC-ME-2
2009_05_26 Study Changes Recruitment status, Recruitment, Misc.
1 clinical_study study_id
2
is_fda_regulated Yes
is_section_801 Yes
delayed_posting No
resp_party name_title Stanislaw R. Burzynski
name_title organization Burzynski Clinic
organization resp_party
Fm: Active, not recruiting
To: COMPLETED
status date
Fm: 2008-04
To: 2009-05
date
Fm: 2008-01
To: 2005-02
last_release_date
Fm: 2008-07-23
To: 2009-05-23
http://clinicaltrials.gov/archive/NCT00003509/2009_05_26/changes
So, we know the “COMPLETED” date is:
2009-05-23 (5/23/2009)
To put this in perspective, the below study done in 2006, was NOT published until about 7 years later, in 2013
2/13/2013 – The frequency, cost, and clinical outcomes of HYPERNATREMIA in patients hospitalized to a comprehensive CANCER center
http://www.ncbi.nlm.nih.gov/pubmed/23404230
Over 3 month period in 2006 re 3,446 patients, most of the HYPERNATREMIA (90 %) was acquired during hospital stay
http://www.ncbi.nlm.nih.gov/m/pubmed/23404230
Division of Internal Medicine, UT MD Anderson Cancer Center, Houston, TX, USA
Department of General Internal Medicine, University of Texas MD Anderson Cancer Center
Division of Endocrinology, Mayo Clinic
Support Care Cancer. 2013 Feb 13. [Epub ahead of print]
Supportive Care in Cancer
February 2013
DOI
10.1007/s00520-013-1734-6
http://link.springer.com/article/10.1007%2Fs00520-013-1734-6
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Let’s look at “FACTS” which are supported by citation(s), reference(s), and / or link(s)
� � � � � � � � � � � � � � � � �
1 – Not Yet Recruiting
(OPEN)(Phase 3)
1 – COMPLETED
2 – WITHDRAWN
(Withdrawn due to slow enrollment)
7 – WITHDRAWN
(This study has been withdrawn prior to enrollment)
(9=WITHDRAWN)
10 – Recruiting
(10=OPEN)
40 – Active, not recruiting –
(40=CLOSED)
61 =TOTAL
� � � � � � � � � � � � � � � � �
1 – Not Yet Recruiting + 10 – Recruiting –
(11=OPEN)
2 – WITHDRAWN
(Withdrawn due to slow enrollment)
7 – WITHDRAWN
(This study has been withdrawn prior to enrollment)
(9=WITHDRAWN)
40 – Active, not recruiting –
(40=CLOSED)
(1=COMPLETED)
61=TOTAL
� � � � � � � � � � � � � � � � �
1 – Not Yet Recruiting –
(1=OPEN)
10 Active –
(10=OPEN)
(9=WITHDRAWN)
25 CLOSED +15 CLOSED –
(40=CLOSED)
(1= COMPLETED)
61=TOTAL
� � � � � � � � � � � � � � � � �
10 – Recruiting
(OPEN)
1 Not Yet Recruiting / 10 Recruiting –
(11=OPEN)
(9=WITHDRAWN)
40 – Active, not recruiting
(40=CLOSED)
(1= COMPLETED)
61=TOTAL
� � � � � � � � � � � � � � � � �
11=1 Not Yet Recruiting / 10 Recruiting –
(11=OPEN)
(9=WITHDRAWN)
(40=CLOSED)
(1= COMPLETED)
61=TOTAL
� � � � � � � � � � � � � � � � �
11 – OPEN (ACTIVE)
2 – WITHDRAWN
(Withdrawn due to slow enrollment)
7 – WITHDRAWN
(This study has been withdrawn prior to enrollment)
= 9 WITHDRAWN
� � � � � � � � � � � � � � � � �
1 – Not Yet Recruiting
(1=OPEN)(Phase 3)
10 – Recruiting
(10=OPEN)
11=TOTAL
� � � � � � � � � � � � � � � � �
1 – Not Yet Recruiting + 10 – Recruiting –
(11=OPEN)
11=TOTAL
� � � � � � � � � � � � � � � � �
1 – Not Yet Recruiting –
(1=OPEN)
10 Active –
(10=OPEN)
11=TOTAL
� � � � � � � � � � � � � � � � �
10 – Recruiting
(OPEN)
1 Not Yet Recruiting / 10 Recruiting –
(11=OPEN)
11=TOTAL
� � � � � � � � � � � � � � � � �
11=1 Not Yet Recruiting / 10 Recruiting –
(11=OPEN)
11=TOTAL
� � � � � � � � � � � � � � � � �
The below 1st link: 10 Active (Open):
http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11475951
� � � � � � � � � � � � � � � � �
1. Antineoplaston Therapy in Treating Patients With Stage IV ADRENAL GLAND Cancer
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months and over
Sponsor: Other
Protocol IDs: CDR0000066485, BC-AD-2, NCT00003453
2. Antineoplaston Therapy in Treating PATIENTS WITH BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066489, BC-BT-9, NCT00003457
3. Antineoplaston Therapy in Treating CHILDREN WITH BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066490, BC-BT-10, NCT00003458
4. Antineoplaston Therapy in Treating CHILDREN WITH LOW-GRADE ASTROCYTOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066504, BC-BT-13, NCT00003468
5. Antineoplaston Therapy in Treating PATIENTS WITH ANAPLASTIC ASTROCYTOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066507, BC-BT-15, NCT00003470
6. Antineoplaston Therapy in Treating Patients With Recurrent or Refractory MIXED GLIOMAs
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066510, BC-BT-18, NCT00003473
7. Antineoplaston Therapy in Treating PATIENTS WITH PRIMARY MALIGNANT BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066512, BC-BT-21, NCT00003475
8. Antineoplaston Therapy in Treating CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066513, BC-BT-22, NCT00003476
9. Antineoplaston Therapy in Treating CHILDREN WITH VISUAL PATHWAY GLIOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066514, BC-BT-23, NCT00003477
10. Antineoplaston Therapy in Treating Patients With Residual or Recurrent ANAPLASTIC ASTROCYTOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066585, BC-BT-8, NCT00003537
� � � � � � � � � � � � � � � � �
Securities and Exchange Commission (SEC) filings 10 “ACTIVE” (OPEN) trials:
Burzynski Clinical Trials (The SEC filings):
https://stanislawrajmundburzynski.wordpress.com/2013/04/11/burzynski-clinical-trials-2/
11/25/1997 – FORM 10-SB
Click to access 0000950110-97-001598.pdf
11/25/1997 – Company sponsoring 72 Phase II clinical trials conducted pursuant to INDs filed with FDA which are currently ongoing
� � � � � � � � � � � � � � � � �
1. AD-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE ADRENAL GLAND
7/20/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
2. BT-9 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH BRAIN TUMORS
11 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
3. BT-10 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH BRAIN TUMORS
5 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
4. BT-13 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH LOW GRADE ASTROCYTOMA
7 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
9/5/97 – Revised
5. BT-15 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN ADULT PATIENTS WITH ANAPLASTIC ASTROCYTOMA
7/26/96 – Revised
10/4/96 – Revised
4/14/97 – Revised
9/5/97 – Revised
6. BT-18 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN ADULT PATIENTS WITH MIXED GLIOMA
12 40
7/26/96 – Revised
10/4/96 – Revised
12/9/96 – Revised
4/14/97 – Revised
7. BT-21 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN ADULT PATIENTS WITH PRIMARY MALIGNANT BRAIN TUMORS
19 40
9/5/95 – Partially Amended, pg.
9/10/96 – Revised
4/14/97 – Revised
8/25/97 – Revised
8. BT-22 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS
4 40
11/5/97 – Partially Amended, pg.
4/14/97 – Revised
9/10/97 – Revised
9. BT-23 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN CHILDREN WITH VISUAL PATHWAY GLIOMA
2 40
5/22/96 –
11/18/96 – Revised
4/14/97 – Revised
10. BT-8 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH ANAPLASTIC ASTROCYTOMA
9 40
4/14/97 – Revised
9/15/97 – Revised
� � � � � � � � � � � � � � � � �
1. – 10. (2) CONSOLIDATED:
� � � � � � � � � � � � � � � � �
1. AD-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE ADRENAL GLAND
7/20/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
1. Antineoplaston Therapy in Treating Patients With Stage IV ADRENAL GLAND Cancer
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months and over
Sponsor: Other
Protocol IDs: CDR0000066485, BC-AD-2, NCT00003453
2. BT-9 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH BRAIN TUMORS
11 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
2. Antineoplaston Therapy in Treating PATIENTS WITH BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066489, BC-BT-9, NCT00003457
3. BT-10 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH BRAIN TUMORS
5 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
3. Antineoplaston Therapy in Treating CHILDREN WITH BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066490, BC-BT-10, NCT00003458
4. BT-13 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH LOW GRADE ASTROCYTOMA
7 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
9/5/97 – Revised
4. Antineoplaston Therapy in Treating CHILDREN WITH LOW-GRADE ASTROCYTOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066504, BC-BT-13, NCT00003468
5. BT-15 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN ADULT PATIENTS WITH ANAPLASTIC ASTROCYTOMA
7/26/96 – Revised
10/4/96 – Revised
4/14/97 – Revised
9/5/97 – Revised
5. Antineoplaston Therapy in Treating PATIENTS WITH ANAPLASTIC ASTROCYTOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066507, BC-BT-15, NCT00003470
6. BT-18 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN ADULT PATIENTS WITH
MIXED GLIOMA
12 40
7/26/96 – Revised
10/4/96 – Revised
12/9/96 – Revised
4/14/97 – Revised
6. Antineoplaston Therapy in Treating Patients With Recurrent or Refractory MIXED GLIOMAs
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066510, BC-BT-18, NCT00003473
7. BT-21 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN ADULT PATIENTS WITH PRIMARY MALIGNANT BRAIN TUMORS
19 40
9/5/95 – Partially Amended, pg.
9/10/96 – Revised
4/14/97 – Revised
8/25/97 – Revised
7. Antineoplaston Therapy in Treating PATIENTS WITH PRIMARY MALIGNANT BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066512, BC-BT-21, NCT00003475
8. BT-22 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS
4 40
11/5/97 – Partially Amended, pg.
4/14/97 – Revised
9/10/97 – Revised
8. Antineoplaston Therapy in Treating CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066513, BC-BT-22, NCT00003476
9. BT-23 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN CHILDREN WITH VISUAL PATHWAY GLIOMA
2 40
5/22/96 –
11/18/96 – Revised
4/14/97 – Revised
9. Antineoplaston Therapy in Treating CHILDREN WITH VISUAL PATHWAY GLIOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066514, BC-BT-23, NCT00003477
10. BT-8 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH ANAPLASTIC ASTROCYTOMA
9 40
4/14/97 – Revised
9/15/97 – Revised
10. Antineoplaston Therapy in Treating Patients With Residual or Recurrent ANAPLASTIC ASTROCYTOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066585, BC-BT-8, NCT00003537
� � � � � � � � � � � � � � � � �
Burzynski Clinical Trials (The SEC filings):
https://stanislawrajmundburzynski.wordpress.com/2013/04/11/burzynski-clinical-trials-2/
Certain prospective protocols which have reached a Milestone as of May 1, 2012
The results of Protocols
10. BT-08
2. BT-09
3. BT-10
4. BT-13
5. BT-15
6. BT-18
7. BT-21
8. BT-22
9. BT-23
5/1/2012 – set forth below
1. Antineoplaston Therapy in Treating Patients With Stage IV ADRENAL GLAND Cancer
Adrenocortical Carcinoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 6 months and over
Protocol IDs
CDR0000066485
BC-AD-2, NCT00003453
http://cancer.gov/clinicaltrials/BC-AD-2
2. Antineoplaston Therapy in Treating PATIENTS WITH BRAIN TUMORS
Brain and Central Nervous System Tumors
Drug: antineoplaston
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066489
BC-BT-9, NCT00003457
http://cancer.gov/clinicaltrials/BC-BT-9
· Protocol BT-09, involving the study of Antineoplastons A10 and AS2-1 in PATIENTS WITH BRAIN TUMORS
BT-09 – Protocol #
40 – Patients Accrued
28 – Evaluable Patients
4 / 14.3% – # and % of Patients Showing Complete Response
5 / 17.9% – # and % of Patients Showing Partial Response
13 / 46.4% – # and % of Patients Showing Stable Disease
6 / 21.4% – # and % of Patients Showing Progressive Disease
3. Antineoplaston Therapy in Treating CHILDREN WITH BRAIN TUMORS
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 6 months to 17 years
Protocol IDs
CDR0000066490
BC-BT-10, NCT00003458
http://cancer.gov/clinicaltrials/BC-BT-10
· Protocol BT-10, involving the study of Antineoplastons A10 and AS2-1 in CHILDREN WITH BRAIN TUMORS
BT-10 – Protocol #
30 – Patients Accrued
22 – Evaluable Patients
3 / 13.6% – # and % of Patients Showing Complete Response
1 / 4.5% – # and % of Patients Showing Partial Response
7 / 31.8% – # and % of Patients Showing Stable Disease
11 / 50.0% – # and % of Patients Showing Progressive Disease
4. Antineoplaston Therapy in Treating CHILDREN WITH LOW-GRADE ASTROCYTOMA
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 6 months to 17 years
Protocol IDs
CDR0000066504
BC-BT-13, NCT00003468
http://cancer.gov/clinicaltrials/BC-BT-13
· Protocol BT-13, involving the study of Antineoplastons A10 and AS2-1 in CHILDREN WITH LOW GRADE ASTROCYTOMA, a type of PMBT
BT-13 – Protocol #
17 – Patients Accrued
14 – Evaluable Patients
6 / 42.9% – # and % of Patients Showing Complete Response
1 / 7.1% – # and % of Patients Showing Partial Response
5 / 35.7% – # and % of Patients Showing Stable Disease
2 / 14.3% – # and % of Patients Showing Progressive Disease
5. Antineoplaston Therapy in Treating PATIENTS WITH ANAPLASTIC ASTROCYTOMA
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066507
BC-BT-15, NCT00003470
http://cancer.gov/clinicaltrials/BC-BT-15
· Protocol BT-15, involving the study of Antineoplastons A10 and AS2-1 in adult PATIENTS WITH ANAPLASTIC ASTROCYTOMA, a type of PMBT
BT-15 – Protocol #
27 – Patients Accrued
20 – Evaluable Patients
3 / 15.0% – # and % of Patients Showing Complete Response
2 / 10.0% – # and % of Patients Showing Partial Response
9 / 45.0% – # and % of Patients Showing Stable Disease
6 / 30.0% – # and % of Patients Showing Progressive Disease
6. Antineoplaston Therapy in Treating Patients With Recurrent or Refractory MIXED GLIOMAs
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066510
BC-BT-18, NCT00003473
http://cancer.gov/clinicaltrials/BC-BT-18
Protocol BT-18, involving a study of Antineoplastons A10 and AS2-1 in the treatment of “MIXED GLIOMA,” a type of PMBT
BT-18 – Protocol #
20 – Patients Accrued
13 – Evaluable Patients
3 / 23.1% – # and % of Patients Showing Complete Response
1 / 7.7% – # and % of Patients Showing Partial Response
3 / 23.1% – # and % of Patients Showing Stable Disease
6 / 46.2% – # and % of Patients Showing Progressive Disease
7. Antineoplaston Therapy in Treating Patients With PRIMARY MALIGNANT BRAIN TUMORS
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066512
BC-BT-21, NCT00003475
http://cancer.gov/clinicaltrials/BC-BT-21
· Protocol BT-21, involving the study of Antineoplastons A10 and AS2-1 in adults with PRIMARY MALIGNANT BRAIN TUMORS
BT-21 – Protocol #
40 – Patients Accrued
23 – Evaluable Patients
2 / 8.7% – # and % of Patients Showing Complete Response
2 / 8.7% – # and % of Patients Showing Partial Response
9 / 39.1% – # and % of Patients Showing Stable Disease
10 / 43.5% – # and % of Patients Showing Progressive Disease
8. Antineoplaston Therapy in Treating CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 6 months to 17 years
Protocol IDs
CDR0000066513
BC-BT-22, NCT00003476
http://cancer.gov/clinicaltrials/BC-BT-22
· Protocol BT-22, involving a study of Antineoplastons A10 and AS2-1 in CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS
BT-22 – Protocol #
40 – Patients Accrued
24 – Evaluable Patients
1 / 4.2% – # and % of Patients Showing Complete Response
3 / 12.5% – # and % of Patients Showing Partial Response
9 / 37.5% – # and % of Patients Showing Stable Disease
11 / 45.8% – # and % of Patients Showing Progressive Disease
9. Antineoplaston Therapy in Treating CHILDREN WITH VISUAL PATHWAY GLIOMA
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 6 months to 17 years
Protocol IDs
CDR0000066514
BC-BT-23, NCT00003477
http://cancer.gov/clinicaltrials/BC-BT-23
(· Protocol BT-23, involving a study of Antineoplastons A10 and AS2-1 in CHILDREN WITH VISUAL PATHWAY GLIOMA)
BT-23- Protocol #
16 – Patients Accrued
12 – Evaluable Patients
3 / 25% – # and % of Patients Showing Complete Response
2 / 16.7% – # and % of Patients Showing Partial Response
6 / 50.0% – # and % of Patients Showing Stable Disease
1 / 8.3% – # and % of Patients Showing Progressive Disease
10. Antineoplaston Therapy in Treating Patients With Residual or Recurrent ANAPLASTIC ASTROCYTOMA
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Recruiting
Phase II / Phase 2
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066585
BC-BT-8, NCT00003537
http://cancer.gov/clinicaltrials/BC-BT-8
· Protocol BT-08, involving the study of Antineoplastons A10 and AS2-1 in patients with ANAPLASTIC ASTROCYTOMA
BT-08 – Protocol #
19 – Patients Accrued
14- Evaluable Patients
4 / 28.6% – # and % of Patients Showing Complete Response
0 / 0.0% – # and % of Patients Showing Partial Response
6 / 42.9% – # and % of Patients Showing Stable Disease
4 / 28.6% – # and % of Patients Showing Progressive Disease
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1. – 10. (3) CONSOLIDATED:
� � � � � � � � � � � � � � � � �
1. AD-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE ADRENAL GLAND
7/20/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
1. Antineoplaston Therapy in Treating Patients With Stage IV ADRENAL GLAND Cancer
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months and over
Sponsor: Other
Protocol IDs: CDR0000066485, BC-AD-2, NCT00003453
1. Antineoplaston Therapy in Treating Patients With Stage IV ADRENAL GLAND Cancer
Adrenocortical Carcinoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 6 months and over
Protocol IDs
CDR0000066485
BC-AD-2, NCT00003453
http://cancer.gov/clinicaltrials/BC-AD-2
2. BT-9 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH BRAIN TUMORS
11 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
2. Antineoplaston Therapy in Treating PATIENTS WITH BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066489, BC-BT-9, NCT00003457
2. Antineoplaston Therapy in Treating PATIENTS WITH BRAIN TUMORS
Brain and Central Nervous System Tumors
Drug: antineoplaston
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066489
BC-BT-9, NCT00003457
http://cancer.gov/clinicaltrials/BC-BT-9
· Protocol BT-09, involving the study of Antineoplastons A10 and AS2-1 in PATIENTS WITH BRAIN TUMORS
BT-09 – Protocol #
40 – Patients Accrued
28 – Evaluable Patients
4 / 14.3% – # and % of Patients Showing Complete Response
5 / 17.9% – # and % of Patients Showing Partial Response
13 / 46.4% – # and % of Patients Showing Stable Disease
6 / 21.4% – # and % of Patients Showing Progressive Disease
3. BT-10 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH BRAIN TUMORS
5 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
3. Antineoplaston Therapy in Treating CHILDREN WITH BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066490, BC-BT-10, NCT00003458
3. Antineoplaston Therapy in Treating CHILDREN WITH BRAIN TUMORS
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 6 months to 17 years
Protocol IDs
CDR0000066490
BC-BT-10, NCT00003458
http://cancer.gov/clinicaltrials/BC-BT-10
· Protocol BT-10, involving the study of Antineoplastons A10 and AS2-1 in CHILDREN WITH BRAIN TUMORS
BT-10 – Protocol #
30 – Patients Accrued
22 – Evaluable Patients
3 / 13.6% – # and % of Patients Showing Complete Response
1 / 4.5% – # and % of Patients Showing Partial Response
7 / 31.8% – # and % of Patients Showing Stable Disease
11 / 50.0% – # and % of Patients Showing Progressive Disease
4. BT-13 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH LOW GRADE ASTROCYTOMA
7 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
9/5/97 – Revised
4. Antineoplaston Therapy in Treating CHILDREN WITH LOW-GRADE ASTROCYTOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066504, BC-BT-13, NCT00003468
4. Antineoplaston Therapy in Treating CHILDREN WITH LOW-GRADE ASTROCYTOMA
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 6 months to 17 years
Protocol IDs
CDR0000066504
BC-BT-13, NCT00003468
http://cancer.gov/clinicaltrials/BC-BT-13
· Protocol BT-13, involving the study of Antineoplastons A10 and AS2-1 in CHILDREN WITH LOW GRADE ASTROCYTOMA, a type of PMBT
BT-13 – Protocol #
17 – Patients Accrued
14 – Evaluable Patients
6 / 42.9% – # and % of Patients Showing Complete Response
1 / 7.1% – # and % of Patients Showing Partial Response
5 / 35.7% – # and % of Patients Showing Stable Disease
2 / 14.3% – # and % of Patients Showing Progressive Disease
5. BT-15 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN ADULT PATIENTS WITH ANAPLASTIC ASTROCYTOMA
7/26/96 – Revised
10/4/96 – Revised
4/14/97 – Revised
9/5/97 – Revised
5. Antineoplaston Therapy in Treating PATIENTS WITH ANAPLASTIC ASTROCYTOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066507, BC-BT-15, NCT00003470
5. Antineoplaston Therapy in Treating PATIENTS WITH ANAPLASTIC ASTROCYTOMA
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066507
BC-BT-15, NCT00003470
http://cancer.gov/clinicaltrials/BC-BT-15
· Protocol BT-15, involving the study of Antineoplastons A10 and AS2-1 in adult PATIENTS WITH ANAPLASTIC ASTROCYTOMA, a type of PMBT
BT-15 – Protocol #
27 – Patients Accrued
20 – Evaluable Patients
3 / 15.0% – # and % of Patients Showing Complete Response
2 / 10.0% – # and % of Patients Showing Partial Response
9 / 45.0% – # and % of Patients Showing Stable Disease
6 / 30.0% – # and % of Patients Showing Progressive Disease
6. BT-18 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN ADULT PATIENTS WITH
MIXED GLIOMA
12 40
7/26/96 – Revised
10/4/96 – Revised
12/9/96 – Revised
4/14/97 – Revised
6. Antineoplaston Therapy in Treating Patients With Recurrent or Refractory MIXED GLIOMAs
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066510, BC-BT-18, NCT00003473
6. Antineoplaston Therapy in Treating Patients With Recurrent or Refractory MIXED GLIOMAs
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066510
BC-BT-18, NCT00003473
http://cancer.gov/clinicaltrials/BC-BT-18
Protocol BT-18, involving a study of Antineoplastons A10 and AS2-1 in the treatment of “MIXED GLIOMA,” a type of PMBT
BT-18 – Protocol #
20 – Patients Accrued
13 – Evaluable Patients
3 / 23.1% – # and % of Patients Showing Complete Response
1 / 7.7% – # and % of Patients Showing Partial Response
3 / 23.1% – # and % of Patients Showing Stable Disease
6 / 46.2% – # and % of Patients Showing Progressive Disease
7. BT-21 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN ADULT PATIENTS WITH PRIMARY MALIGNANT BRAIN TUMORS
19 40
9/5/95 – Partially Amended, pg.
9/10/96 – Revised
4/14/97 – Revised
8/25/97 – Revised
7. Antineoplaston Therapy in Treating Patients With PRIMARY MALIGNANT BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066512, BC-BT-21, NCT00003475
7. Antineoplaston Therapy in Treating Patients With PRIMARY MALIGNANT BRAIN TUMORS
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066512
BC-BT-21, NCT00003475
http://cancer.gov/clinicaltrials/BC-BT-21
· Protocol BT-21, involving the study of Antineoplastons A10 and AS2-1 in adults with PRIMARY MALIGNANT BRAIN TUMORS
BT-21 – Protocol #
40 – Patients Accrued
23 – Evaluable Patients
2 / 8.7% – # and % of Patients Showing Complete Response
2 / 8.7% – # and % of Patients Showing Partial Response
9 / 39.1% – # and % of Patients Showing Stable Disease
10 / 43.5% – # and % of Patients Showing Progressive Disease
8. BT-22 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS
4 40
11/5/97 – Partially Amended, pg.
4/14/97 – Revised
9/10/97 – Revised
8. Antineoplaston Therapy in Treating CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066513, BC-BT-22, NCT00003476
8. Antineoplaston Therapy in Treating CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 6 months to 17 years
Protocol IDs
CDR0000066513
BC-BT-22, NCT00003476
http://cancer.gov/clinicaltrials/BC-BT-22
· Protocol BT-22, involving a study of Antineoplastons A10 and AS2-1 in CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS
BT-22 – Protocol #
40 – Patients Accrued
24 – Evaluable Patients
1 / 4.2% – # and % of Patients Showing Complete Response
3 / 12.5% – # and % of Patients Showing Partial Response
9 / 37.5% – # and % of Patients Showing Stable Disease
11 / 45.8% – # and % of Patients Showing Progressive Disease
9. BT-23 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN CHILDREN WITH VISUAL PATHWAY GLIOMA
2 40
5/22/96 –
11/18/96 – Revised
4/14/97 – Revised
9. Antineoplaston Therapy in Treating CHILDREN WITH VISUAL PATHWAY GLIOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066514, BC-BT-23, NCT00003477
9. Antineoplaston Therapy in Treating CHILDREN WITH VISUAL PATHWAY GLIOMA
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 6 months to 17 years
Protocol IDs
CDR0000066514
BC-BT-23, NCT00003477
http://cancer.gov/clinicaltrials/BC-BT-23
(· Protocol BT-23, involving a study of Antineoplastons A10 and AS2-1 in CHILDREN WITH VISUAL PATHWAY GLIOMA)
BT-23- Protocol #
16 – Patients Accrued
12 – Evaluable Patients
3 / 25% – # and % of Patients Showing Complete Response
2 / 16.7% – # and % of Patients Showing Partial Response
6 / 50.0% – # and % of Patients Showing Stable Disease
1 / 8.3% – # and % of Patients Showing Progressive Disease
10. BT-8 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH ANAPLASTIC ASTROCYTOMA
9 40
4/14/97 – Revised
9/15/97 – Revised
10. Antineoplaston Therapy in Treating Patients With Residual or Recurrent ANAPLASTIC ASTROCYTOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066585, BC-BT-8, NCT00003537
10. Antineoplaston Therapy in Treating Patients With Residual or Recurrent ANAPLASTIC ASTROCYTOMA
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Recruiting
Phase II / Phase 2
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066585
BC-BT-8, NCT00003537
http://cancer.gov/clinicaltrials/BC-BT-8
· Protocol BT-08, involving the study of Antineoplastons A10 and AS2-1 in patients with ANAPLASTIC ASTROCYTOMA
BT-08 – Protocol #
19 – Patients Accrued
14- Evaluable Patients
4 / 28.6% – # and % of Patients Showing Complete Response
0 / 0.0% – # and % of Patients Showing Partial Response
6 / 42.9% – # and % of Patients Showing Stable Disease
4 / 28.6% – # and % of Patients Showing Progressive Disease
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http://www.burzynskiclinic.com/scientific-publications.html
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
6 months – median duration: treatment
12 patients:
2 years / 33.3% – Survival
2 / 17% – alive and tumour free for over 5 years since initial diagnosis
from start of treatment:
5 years – 1 alive for more than
4 years – 1 alive for more than
Only mild and moderate toxicities observed:
3 – skin allergy
2 – anaemia
2 – fever
2 – hypernatremia
1 – agranulocytosis
1 – hypoglycaemia
1 – numbness
1 – tiredness
1 – myalgia
1 – vomiting
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
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RECURRENT DIFFUSE INTRINSIC BRAIN STEM GLIOMA
11/25/1997 – FORM 10-SB
Click to access 0000950110-97-001598.pdf
10/1997 – clinical trials reached Milestone
Clinical Trial BT-11
trial of Clinical Trial BT-11 involves patients with BRAIN STEM GLIOMA
5/1996 – trial approved by FDA
10/1997 – Protocol – BRAIN STEM GLIOMA
12 – Patients Accrued
12 – Evaluable Patients
1 / 20% – # and % of Patients Showing Complete Response
3 / 30% – # and % of Patients Showing Partial Response
8 / 50% – # and % of Patients Showing Stable Disease or Progressive Disease
BT-11 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH BRAIN STEM GLIOMA
15 40
5/15/96 – Revised
7/11/96 – Revised
9/28/96 – Revised
5/10/97 – Revised
� � � � � � � � � � � � � � � � �
5/1/2012 – prospective protocols which have reached Milestone
results of Protocols:
BT-11
5/1/2012 – set forth below
Form 10-Q (For the fiscal year ended February 29, 2012)
(as of May 1, 2012) Protocol BT
http://www.sec.gov/Archives/edgar/data/724445/000110465912040430/a12-12972_110k.htm
RECURRENT DIFFUSE INTRINSIC BRAIN STEM GLIOMA
Antineoplaston Therapy in Treating Patients With BRAIN STEM GLIOMA
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
CLOSED
Age 6 months and over
Protocol IDs
CDR0000066491
BC-BT-11, NCT00003459
http://cancer.gov/clinicaltrials/BC-BT-11
· Protocol BT-11, involving the study of Antineoplastons A10 and AS2-1 in patients with BRAINSTEM GLIOMA
BT-11 – Protocol #
40 – Patients Accrued
28 – Evaluable Patients
5 / 17.9% – # and % of Patients Showing Complete Response
4 / 14.3% – # and % of Patients Showing Partial Response
12 / 42.9% – # and % of Patients Showing Stable Disease
7 / 25.0% – # and % of Patients Showing Progressive Disease
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BT-11 (RECURRENT DIFFUSE INTRINSIC) BRAIN STEM GLIOMA (3) CONSOLIDATED:
http://clinicaltrials.gov/show/NCT00003459
8/1998 – Study Start Date
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BT-11 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH BRAIN STEM GLIOMA
15 40
5/15/96 – Revised
7/11/96 – Revised
9/28/96 – Revised
5/10/97 – Revised
10/1997 – Protocol BT-11 – BRAIN STEM GLIOMA
12 – Patients Accrued
12 – Evaluable Patients
1 / 20% – # and % of Patients Showing Complete Response
3 / 30% – # and % of Patients Showing Partial Response
8 / 50% – # and % of Patients Showing Stable Disease or Progressive Disease
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
5/1/2012 – Protocol BT-11
Antineoplaston Therapy in Treating Patients With BRAIN STEM GLIOMA
Brain and Central Nervous System Tumors
http://cancer.gov/clinicaltrials/BC-BT-11
· Protocol BT-11 patients with BRAINSTEM GLIOMA
BT-11 – Protocol #
40 – Patients Accrued
28 – Evaluable Patients
5 / 17.9% – # and % of Patients Showing Complete Response
4 / 14.3% – # and % of Patients Showing Partial Response
12 / 42.9% – # and % of Patients Showing Stable Disease
7 / 25.0% – # and % of Patients Showing Progressive Disease
http://clinicaltrials.gov/archive/NCT00003459/2007_10_17/changes
10/17/2007 – Updated
1 clinical_study status
2
Fm: No longer recruiting
To: Active, not recruiting
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Scientific Publications
(former web-site screenshots)
Click to access burzynski_fdauntitled_promo_2012.pdf
http://www.burzynskiclinic.com/scientific-publications.html
Interim Reports on Clinial Trials:
2003 – NEURO-ONCOLOGY
2003 – Phase II study of Antineoplastons A10 and AS2-1 (ANP) in children with recurrent and progressive multicentric glioma
A preliminary report
Neuro-Oncology. 2003; 5: 358
2004 – NEURO-ONCOLOGY
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
Neuro-Oncology. 2004; 6: 384
2004 – 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
Neuro-Oncology. 2004; 6: 386
2004 – NEURO-ONCOLOGY
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
Neuro-Oncology. 2004; 6: 427
2004 – NEURO-ONCOLOGY
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
Neuro-Oncology. 2004; 6: 428
2004 – DRUGS IN R&D
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
Drugs R&D 2004;5(6):315-326
2004 – INTEGRATIVE CANCER THERAPIES
Review Articles on Clinical Trials:
Burzynski, S.R.
The Present State of Antineoplaston Research
Integrative Cancer Therapies 2004;3:47-58
2004 – INTEGRATIVE CANCER THERAPIES
Burzynski, S.R., Lewy, R.I., Weaver, R., Janicki, T., Jurida, G., Khan, M., Larisma, C.B., Paszkowiak, J., Szymkowski, B.
Long-term survival and complete response of a patient with recurrent diffuse intrinsic brain stem glioblastoma multiforme
Integrative Cancer Therapies 2004;3:257-261
2004 – DRUGS IN R&D
Drugs in R and D (Drugs in Research and Development)
2004 – 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
incurable recurrent and progressive multicentric glioma
antineoplaston A10 and AS2-1 (ANP)
9 – median age
6 – pilocytic astrocytoma
4 – low-grade astrocytoma
1 – astrocytoma grade 2
1 – visual pathway glioma: biopsy not performed due to dangerous location
16 months – average duration intravenous ANP therapy
19 months – average duration oral ANP
1 – non-evaluable due to only 4 weeks of ANP: lack of follow-up scans
1 – stable disease discontinued ANP against medical advice: died 4.5 years later
10 – alive and well from 2 to >14 years post-diagnosis
1 – serious toxicity of reversible tinnitus, 1 day’s duration
2004 – Protocol – incurable recurrent and progressive multicentric glioma
12 – Patients Accrued
33% – % of Patients Showing Complete Response
25% – % of Patients Showing Partial Response
33% – % of Patients Showing Stable Disease
0 / 0% – # and % of Patients Showing Progressive Disease
CHILDREN WITH INCURABLE RECURRENT AND PROGRESSIVE MULTICENTRIC GLIOMA
6 – pilocytic astrocytoma
4 – low-grade astrocytoma
1 – astrocytoma grade 2
1 – visual pathway glioma: biopsy not performed due to dangerous location
12 – TOTAL
11/25/1997 – FORM 10-SB
Click to access 0000950110-97-001598.pdf
BT-13 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH LOW GRADE ASTROCYTOMA
7 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
9/5/97 – Revised
BT-23 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN CHILDREN WITH VISUAL PATHWAY
GLIOMA
2 40
5/22/96 –
11/18/96 – Revised
4/14/97 – Revised
5/1/2012 – prospective protocols which have reached Milestone
results of Protocols:
BT-13
BT-23
5/1/2012 – set forth below
Form 10-Q (For the fiscal year ended February 29, 2012)
(as of May 1, 2012) Protocol BT
http://www.sec.gov/Archives/edgar/data/724445/000110465912040430/a12-12972_110k.htm
CHILDREN WITH INCURABLE RECURRENT AND PROGRESSIVE MULTICENTRIC GLIOMA (3) CONSOLIDATED:
6 – pilocytic astrocytoma
4 – low-grade astrocytoma
1 – astrocytoma grade 2
1 – visual pathway glioma: biopsy not performed due to dangerous location
12 – TOTAL
http://clinicaltrials.gov/show/NCT00003468
5/1996 – Study Start Date
BT-13 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH LOW GRADE ASTROCYTOMA
7 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
9/5/97 – Revised
Antineoplaston Therapy in Treating Children With Low-Grade Astrocytoma
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 6 months to 17 years
Protocol IDs
CDR0000066504
BC-BT-13, NCT00003468
http://cancer.gov/clinicaltrials/BC-BT-13
· Protocol BT-13, involving the study of Antineoplastons A10 and AS2-1 in children with low grade astrocytoma, a type of PMBT
BT-13 – Protocol #
17 – Patients Accrued
14 – Evaluable Patients
6 / 42.9% – # and % of Patients Showing Complete Response
1 / 7.1% – # and % of Patients Showing Partial Response
5 / 35.7% – # and % of Patients Showing Stable Disease
2 / 14.3% – # and % of Patients Showing Progressive Disease
http://clinicaltrials.gov/show/NCT00003468
12/2011 – Estimated Primary Completion Date (Final data collection date for primary outcome measure)
6/9/2009 – Updated
1 clinical_study date
2
Fm: 2008-12
To: 2009-06
3 date last_release_date
4
Fm: 2008-12-23
To: 2009-06-09
5 last_release_date clinical_study
http://clinicaltrials.gov/show/NCT00003477
6/1996 – Study Start Date
BT-23 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN CHILDREN WITH VISUAL PATHWAY
GLIOMA
2 40
5/22/96 –
11/18/96 – Revised
4/14/97 – Revised
Antineoplaston Therapy in Treating Children With Visual Pathway Glioma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 6 months to 17 years
Protocol IDs
CDR0000066514
BC-BT-23, NCT00003477
http://cancer.gov/clinicaltrials/BC-BT-23
(· Protocol BT-23, involving a study of Antineoplastons A10 and AS2-1 in children with visual pathway glioma)
BT-23- Protocol #
16 – Patients Accrued
12 – Evaluable Patients
3 / 25% – # and % of Patients Showing Complete Response
2 / 16.7% – # and % of Patients Showing Partial Response
6 / 50.0% – # and % of Patients Showing Stable Disease
1 / 8.3% – # and % of Patients Showing Progressive Disease
http://clinicaltrials.gov/show/NCT00003477
12/2011 – Estimated Primary Completion Date (Final data collection date for primary outcome measure)
http://clinicaltrials.gov/archive/NCT00003477/2009_06_09/changes
6/9/2009 – Updated
1 clinical_study date
2
Fm: 2008-12
To: 2009-06
3 date last_release_date
4
Fm: 2008-12-23
To: 2009-06-09
5 last_release_date clinical_study
� � � � � � � � � � � � � � � � �
2005 – INTEGRATIVE CANCER THERAPIES
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
Integrative Cancer Therapies 2005;4(2):168-177
2005 – INTEGRATIVE CANCER THERAPIES
6/2005 – 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
Phase II / Phase 2 studies
Primitive neuroectodermal tumors (PNETs)
usually successfully treated with craniospinal radiation and chemotherapy
difficulties with standard treatment can be encountered in:
1. very young children
2. adult patients at high risk of complication from standard treatment
3. patients with recurrent tumors
13 children – recurrent disease or high risk
treated with antineoplastons (ANP)
5 years, 7 months (range, 1-11) – median age
8 – Medulloblastoma
3 – pineoblastoma
2 – other PNET
Previous treatments:
12 – surgery (1 had biopsy only, suboccipital craniotomy)
6 – chemotherapy
6 – radiation therapy
6 – had not received prior chemotherapy or radiation
treatment – intravenous infusions of 2 formulations of ANP, A10 and AS2-1
20 months – administered for average
6 (46%) survived more than 5 years from initiation of ANP
5 – not treated earlier with radiation therapy or chemotherapy
serious side effects:
1 – fever
1 – granulocytopenia
1 – anemia
study ongoing and accruing additional patients
percentage of response is lower than standard treatment of favorable PNET
long-term survival in poor-risk cases and reduced toxicity makes ANP promising for:
1. very young children
2. patients at high risk of complication of standard therapy
3. patients with recurrent tumors
2005 – Protocol – Long-term survival of high-risk pediatric patients with primitive neuroectodermal tumors
13 – Patients Accrued
23% – % of Patients Showing Complete Response
8% – % of Patients Showing Partial Response
31% – % of Patients Showing Stable Disease
38% – # and % of Patients Showing Progressive Disease
LONG-TERM SURVIVAL OF HIGH-RISK PEDIATRIC PATIENTS WITH PRIMITIVE NEUROECTODERMAL TUMORS:
8 – Medulloblastoma
3 – pineoblastoma
2 – other
PNET (Primitive neuroectodermal tumors)
13 – TOTAL
11/25/1997 – FORM 10-SB
Click to access 0000950110-97-001598.pdf
BT-12 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH PRIMITIVE NEUROECTODERMAL TUMORS; (PNET)
5 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
5/1/2012 – prospective protocols which have reached Milestone
results of Protocols:
BT-12
5/1/2012 – set forth below
Form 10-Q (For the fiscal year ended February 29, 2012)
(as of May 1, 2012) Protocol BT
http://www.sec.gov/Archives/edgar/data/724445/000110465912040430/a12-12972_110k.htm
LONG-TERM SURVIVAL OF HIGH-RISK PEDIATRIC PATIENTS WITH PRIMITIVE NEUROECTODERMAL TUMORS:
8 – Medulloblastoma
3 – pineoblastoma
2 – other PNET (Primitive neuroectodermal tumors)
13 – TOTAL
http://clinicaltrials.gov/show/NCT00003460
9/1995 – Study Start Date
BT-12 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH PRIMITIVE NEUROECTODERMAL TUMORS; (PNET)
5 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
Antineoplaston Therapy in Treating Children With Primitive Neuroectodermal Tumors
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
CLOSED
Age 6 months to 17 years
Protocol IDs
CDR0000066492
BC-BT-12, NCT00003460
http://cancer.gov/clinicaltrials/BC-BT-12
· Protocol BT-12, involving the study of Antineoplastons A10 and AS2-1 in Children With Primitive Neuroectodermal Tumors
http://clinicaltrials.gov/show/NCT00003460
12/2011 – Estimated Primary Completion Date (Final data collection date for primary outcome measure)
7/14/2009 – Updated
1 clinical_study oversight_info
2 regulatory_authority
United States: Federal Government
3 oversight_info status
4
Fm: Recruiting
To: Active, not recruiting
5 status last_release_date
6
Fm: 2009-06-09
To: 2009-07-14
7 last_release_date
8 init_disposition_release_date
9 init_results_release_date clinical_study
Antineoplaston Therapy in Treating Children With Primitive Neuroectodermal Tumors
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
CLOSED
Age 6 months to 17 years
Protocol IDs
CDR0000066492
BC-BT-12, NCT00003460
http://cancer.gov/clinicaltrials/BC-BT-12
· Protocol BT-12, involving the study of Antineoplastons A10 and AS2-1 in children with primitive neuroectodermal tumors (PNET)
BT-12 – Protocol #
13 – Patients Accrued
11 – Evaluable Patients
3 / 27.3% – # and % of Patients Showing Complete Response
1 / 9.1% – # and % of Patients Showing Partial Response
3 / 27.3% – # and % of Patients Showing Stable Disease
4 / 36.4% – # and % of Patients Showing Progressive Disease
5/1/2012 – prospective protocols which have reached Milestone
results of Protocols:
BT-12
5/1/2012 – set forth below
Form 10-Q (For the fiscal year ended February 29, 2012)
(as of May 1, 2012) Protocol BT
http://www.sec.gov/Archives/edgar/data/724445/000110465912040430/a12-12972_110k.htm
Antineoplaston Therapy in Treating Children With Primitive Neuroectodermal Tumors
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
CLOSED
Age 6 months to 17 years
Protocol IDs
CDR0000066492
BC-BT-12, NCT00003460
http://cancer.gov/clinicaltrials/BC-BT-12
BT-12 – Protocol #
13 – Patients Accrued
11 – Evaluable Patients
3 / 27.3% – # and % of Patients Showing Complete Response
1 / 9.1% – # and % of Patients Showing Partial Response
3 / 27.3% – # and % of Patients Showing Stable Disease
4 / 36.4% – # and % of Patients Showing Progressive Disease
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
Iwaaaa.pdf
Neuro-Oncology. 2006; 8:466
2006 – INTEGRATIVE CANCER THERAPIES
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
2006 – PEDIATRIC DRUGS
Burzynski, S.R.
Treatments for Astrocytic Tumors in Children: Current and Emerging Strategies
Pediatric Drugs 2006;8:167-178
2006 – NEURO-ONCOLOGY
Burzynski, S.R., Weaver, R.A., Szymkowski, B., Janicki, T.J., Khan, M.I., Dolgopolov, V.
Complete response of a diffuse intrinsic brainstem tumor and von Hippel Lindau (VHL) disease to antineoplastons A10 and AS2-1 (ANP):
a case report
Neuro-Oncology. 2006; 8:439
3/2006 – INTEGRATIVE CANCER THERAPIES
3/2006 – 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
Brainstem glioma carries worst prognosis of all malignancies of the brain
Most patients with brainstem glioma fail standard radiation therapy and chemotherapy and do not survive longer than 2 years
Treatment even more challenging when inoperable tumor of high-grade pathology (HBSG)
patients with inoperable tumor of high-grade pathology (HBSG) treated with antineoplastons in 4 phase 2 trials
39% – overall survival at 2 years
22% – overall survival at 5 years
17+ years maximum survival – patient with anaplastic astrocytoma
5+ years – patient with glioblastoma
39% – Progression-free survival at 6 months
5+ year survival in recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of brainstem in small group of patients
18 – evaluable
4 – glioblastomas
14 – anaplastic HBSG
14 – diffuse intrinsic tumors
12 – recurrence
6 – did not have radiation therapy or chemotherapy
Antineoplastons A10 (A10I) and AS2-1 injections
5 months – median duration
Responses assessed by gadolinium-enhanced magnetic resonance imaging and positron emission tomography
Antineoplastons tolerated very well:
1 case – grade 4 toxicity (reversible anemia)
2006 – Protocol – high-grade pathology (HBSG)
18 – Evaluable Patients
11% – % of Patients Showing Complete Response
11% – % of Patients Showing Partial Response
39% – % of Patients Showing Stable Disease
39% – % of Patients Showing Progressive Disease
INOPERABLE TUMOR OF HIGH-GRADE PATHOLOGY (HBSG), RECURRENT, AND PROGRESSIVE BRAINSTEM GLIOMA:
4 – glioblastomas (patient with glioblastoma)
14 – anaplastic HBSG (patient with anaplastic astrocytoma)
18 – TOTAL ; evaluable)
14 – diffuse intrinsic tumors
12 – recurrence
(recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of brainstem)
6 – did not have radiation therapy or chemotherapy
18 – TOTAL
11/25/1997 – FORM 10-SB
Click to access 0000950110-97-001598.pdf
patients with inoperable tumor of high-grade pathology (HBSG) treated with antineoplastons in 4 PHASE 2 TRIALS:
INOPERABLE TUMOR OF HIGH-GRADE PATHOLOGY (HBSG), RECURRENT, AND PROGRESSIVE BRAINSTEM GLIOMA:
4 – glioblastomas (patient with glioblastoma)
14 – anaplastic HBSG (patient with anaplastic astrocytoma)
18 – TOTAL ; evaluable)
14 – diffuse intrinsic tumors
12 – recurrence
(recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of brainstem)
6 – did not have radiation therapy or chemotherapy
18 – TOTAL
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