Burzynski: The Clinical Trials

(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:
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50 – Unknown
7 – Withdrawn
2 – Terminated
1 – Not yet recruiting
1 – Completed
61 – TOTAL
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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2 – Terminated (Withdrawn due to slow enrollment)
7 – Withdrawn (This study has been withdrawn prior to enrollment)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
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Below 1 st link: 10 Active (Open):
http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11475951
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Below 2nd link: 25 Closed-1st screen / 15 Closed-1 Completed-2nd screen:
http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11476036
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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2 – Terminated (Withdrawn due to slow enrollment)
7 – Withdrawn (This study has been withdrawn prior to enrollment)
9=WITHDRAWN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
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1=COMPLETED
9=WITHDRAWN
11=OPEN
40=CLOSED
61-TOTAL
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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)
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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
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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
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1 – Not Yet Recruiting –
(1=OPEN)
10 Active –
(10=OPEN)
(9=WITHDRAWN)
25 CLOSED +15 CLOSED –
(40=CLOSED)
(1= COMPLETED)
61=TOTAL
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10 – Recruiting
(OPEN)
1 Not Yet Recruiting / 10 Recruiting –
(11=OPEN)
(9=WITHDRAWN)
40 – Active, not recruiting
(40=CLOSED)
(1= COMPLETED)
61=TOTAL
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11=1 Not Yet Recruiting / 10 Recruiting –
(11=OPEN)
(9=WITHDRAWN)
(40=CLOSED)
(1= COMPLETED)
61=TOTAL
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11 – OPEN (ACTIVE)
2 – WITHDRAWN
(Withdrawn due to slow enrollment)
7 – WITHDRAWN
(This study has been withdrawn prior to enrollment)
= 9 WITHDRAWN
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1 – Not Yet Recruiting
(1=OPEN)(Phase 3)
10 – Recruiting
(10=OPEN)
11=TOTAL
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1 – Not Yet Recruiting + 10 – Recruiting –
(11=OPEN)
11=TOTAL
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1 – Not Yet Recruiting –
(1=OPEN)
10 Active –
(10=OPEN)
11=TOTAL
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10 – Recruiting
(OPEN)
1 Not Yet Recruiting / 10 Recruiting –
(11=OPEN)
11=TOTAL
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11=1 Not Yet Recruiting / 10 Recruiting –
(11=OPEN)
11=TOTAL
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The below 1st link: 10 Active (Open):
http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11475951
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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
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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
http://pdf.secdatabase.com/2573/0000950110-97-001598.pdf
11/25/1997 – Company sponsoring 72 Phase II clinical trials conducted pursuant to INDs filed with FDA which are currently ongoing
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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
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1. – 10. (2) CONSOLIDATED:
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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
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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
� � � � � � � � � � � � � � � � �
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
http://www.burzynskiclinic.com/images/stories/Publications/960.pdf
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
http://pdf.secdatabase.com/2573/0000950110-97-001598.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
� � � � � � � � � � � � � � � � �
BT-11 (RECURRENT DIFFUSE INTRINSIC) BRAIN STEM GLIOMA (3) CONSOLIDATED:
http://clinicaltrials.gov/show/NCT00003459
8/1998 – Study Start Date
� � � � � � � � � � � � � � � � �
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
� � � � � � � � � � � � � � � � �

Scientific Publications
(former web-site screenshots)
http://www.circare.org/info/bri/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
http://www.burzynskiclinic.com/images/stories/Publications/970.pdf
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
http://www.burzynskiclinic.com/images/stories/Publications/1218.pdf
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
http://www.burzynskiclinic.com/images/stories/Publications/1219.pdf
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
http://www.burzynskiclinic.com/images/stories/Publications/1146.pdf
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
http://www.burzynskiclinic.com/images/stories/Publications/1147.pdf
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
http://www.burzynskiclinic.com/images/stories/Publications/1194.pdf
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
http://www.burzynskiclinic.com/images/stories/Publications/994.pdf
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
http://www.burzynskiclinic.com/images/stories/Publications/1145.pdf
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
http://pdf.secdatabase.com/2573/0000950110-97-001598.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
http://www.burzynskiclinic.com/images/stories/Publications/1220.pdf
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
http://pdf.secdatabase.com/2573/0000950110-97-001598.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
http://www.burzynskiclinic.com/images/stories/Publications/5825.pdf
Integrative Cancer Therapies 2006;5(1):40-47

2006 – PEDIATRIC DRUGS

Burzynski, S.R.

Treatments for Astrocytic Tumors in Children: Current and Emerging Strategies
http://www.burzynskiclinic.com/images/stories/Publications/1252.pdf
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
http://www.burzynskiclinic.com/images/stories/Publications/2104.pdf
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
http://pdf.secdatabase.com/2573/0000950110-97-001598.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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