11/25/1997 – Filing Date
Click to access 0000950110-97-001598.pdf
FORM 10-SB
Company’s IND applications have been approved by FDA and Company’s conducting FDA-approved clinical trials
at present time all Burzynski’s patients are enrolled in FDA approved clinical trials or have FDA approval under special exceptions
medical chemical compounds composed of growth-inhibiting peptides, amino acid derivatives and organic acids which are known under trade name “Antineoplastons
Company’s currently conducting Phase II clinical trials of Antineoplastons
Burzynski has developed 6 formulations of natural Antineoplastons and 6 synthetic formulations of Antineoplastons
All Phase II clinical trials currently sponsored by Company involve use of 4 formulations of synthetic Antineoplastons known as A10 and AS2-1 in capsules and injections
Company currently conducting laboratory research involving new generation of Antineoplastons A10 and AS2-1
anticancer activity of compounds has been documented in preclinical studies employing methods of cell culture, pharmacology, cell biology, molecular oncology, experimental therapeutics and animal models of cancer
At level of clinical studies, Company believes that anticancer activity of Antineoplastons is supported by preliminary results from ongoing FDA authorized Phase II clinical trials
cellular mechanism underlying anticancer effects of Antineoplastons continues to be investigated in Company’s own basic preclinical research program and independent laboratories around the world
review of work suggests several mechanisms may underlie antineoplastic activity of Antineoplastons
it has been found, in cell culture experiments, that Antineoplastons induce pathologically undifferentiated cancer cells to assume more normal state of differentiation
Cell culture experiments have shown Antineoplaston components can kill some cancer cells by activating cell’s intrinsic “suicide” program
data collected in cell culture experiments may or may not indicate mechanism of action of Antineoplastons in humans
At more molecular or sub-cellular level, cell culture experiments have shown Antineoplastons can block biochemical pathways involving oncogenes required to produce abnormal cell growth
cell culture experiments have shown Antineoplastons can increase expression of anticancer tumor suppressor genes
experiments conducted using human cancer cells, they may or may not indicate mechanism of Antineoplaston action in humans
In addition to original family of Antineoplaston compounds (the “Parental Generation”), Company continues development of 2nd generation of Antineoplastons
In cell culture experiments 2nd generation Antineoplastons developed by Company, have been shown to be at least a thousand times more potent then Parental Generation
Company developing 3rd generation structurally altered Antineoplaston Company believes will exhibit markedly improved anticancer activity in human cancer cell lines resistant to Parental Generation
increases of antineoplastic activity in cell culture experiments may or may not translate into increased efficacy in humans
Company involved in ongoing studies examining pharmacokinetics (absorption, distribution, metabolism, and excretion) and pharmacodynamics (dose-response) of Antineoplastons in patients with neoplastic disease
Company primarily engaged in research and development of drugs currently being tested for use in treatment of cancer, and provides chemical consulting services
All clinical trials are conducted in Houston
One of clinical trials is for treatment of breast cancer using Antineoplaston A10 capsules in combination with FDA-approved drug Methotrexate
All other clinical trials are for treatment of wide variety of cancers using only combination of Antineoplastons A10 and AS2-1
In most trials intravenous formulations of Antineoplastons are used
In few other trials, oral formulations of Antineoplastons are used
All Company’s clinical trials, except study with Antineoplaston A10 and Methotrexate involve use of Historic Controls
Where tumor size is used as Milestone
clinical trial Protocol describes
“complete response” is complete disappearance of all tumors with no reoccurrence of tumors for at least 4 weeks
“partial response” is at least 50% reduction in size of total tumor size, with such reduction lasting at least 4 weeks
A “response” is either complete or partial response
“Stable disease” is less than 50% reduction in size but no more than 50% increase in size of tumor mass, lasting for at least 12 weeks
“Progressive disease” is more than 50% increase in total tumor mass or occurrence of new tumors
protocols of Company’s clinical trials are a 2-stage design, wherein 20 patients are initially to be accrued
After specified time period, if 0 responses by patients after 1st 20 patients, trial will be discontinued and drug declared to have less than desired activity
If at least one response, trial will be continued until 40 patients accrued
If study continues, following conclusions according to protocols based on 40 patients can be made:
If 3 or fewer responses, there’s less than desired activity
If there are 4 or more responses, there is sufficient evidence to conclude that Antineoplaston regimen used shows beneficial activity
There are no clinical trials being conducted that involve “double blind” studies and all but one clinical trial involve no randomization into multiple treatment groups
one randomized trial is of A10 capsules plus Methotrexate, a proven chemotherapy agent, in treatment of breast cancer
In trial, persons are randomized into one of 2 groups
one group receives Methotrexate alone
one group receives Methotrexate and A10 capsules
10/1997 only 2 clinical trials reached Milestone
These are
Clinical Trial BT-11
and
Clinical Trial BT-18
Clinical Trial BT-18 involving intravenous administration of Antineoplastons A10 and AS2-1 in treatment of “mixed glioma”, a type of PMBT
3/1996 – trial approved by FDA
results evaluated after 9 patients accrued
Of these there have been
2 complete responses
2 partial responses
Another trial of Clinical Trial BT-11 involves patients with brain stem glioma
trial approved by FDA 5/1996
12 patients accrual
1 complete
3 partial responses
there can be no assurance that results of
Clinical Trial BT-11
or
Clinical Trial BT-18
can be repeated or that other clinical trials will result in same or similar responses
Company intends to release updated information when it becomes available
one trial that’s retrospective is CAN-1 Clinical Trial of patients treated by Burzynski through 2/23/1996
analysis has been made of patients with PMBT in CAN-1 trial
40 evaluable patients
17 experienced more than 50% reduction in size of tumors of whom 7 had complete disappearance of tumor
FDA indicated it will not accept data generated by this trial since it wasn’t wholly prospective one
Notwithstanding response results of
Clinical Trial BT-11
and
Clinical Trial BT-18
management believes it’s likely that FDA may require additional clinical trials based upon
Clinical Trial BT-11
and
Clinical Trial BT-18
Protocols be conducted by institution not affiliated with Company or Burzynski before advising that NDA filing is warranted
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
BL-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE BLADDER
3 40
7/20/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
BR-10 PROTOCOL FOR RANDOMIZED CONTROLLED TRIAL COMPARING METHOTREXATE TREATMENT ALONE TO THE COMBINATION OF METHOTREXATE AND ANTINEOPLASTON A10
7 40
4/12/97 – Revised
7/28/97 – Revised
BR-12 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE BREAST 17 40
7/20/96 – Revised
4/29/97 – Revised
BR-14 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 CAPSULES IN PATIENTS WITH ADVANCED BREAST CANCER
6 40
8/26/96 –
12/10/96 – Revised
4/12/97 – Revised
BR-6 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN CHILDREN WITH HIGH GRADE GLIOMA
9 40
3/1996
BT-7 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH GLIOBLASTOMA MULTIFORME
34 40
3/1996;
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
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
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
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
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
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-14 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH RHABDOID TUMOR OF THE CENTRAL NERVOUS SYSTEM
3 40
5/17/96 – Revised
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
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
BT-16 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN ADULT PATIENTS WITH LOW GRADE ASTROCYTOMA
5 40
7/26/96 – Revised
10/4/96 – Revised
4/14/97 – Revised
BT-17 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN ADULT PATIENTS WITH OLIGODENDROGLIOMA
5 40
7/26/96 – Revised
10/4/96 – Revised
4/14/97 – Revised
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
BT-19 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH NEUROFIBROMA AND SCHWANNOMA
0 40
4/14/97 – Revised
BT-20 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN ADULT PATIENTS WITH GLIOBLASTOMA MULTIFORME
35 40
7/26/96 – Revised
10/4/96 – Revised
4/14/97 – Revised
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
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
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
BT-24 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN PATIENTS WITH EPENDYMOMA
7 40
5/15/96 –
11/18/96 – Revised
4/14/97 – Revised
BT-25 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN PATIENTS WITH CRANIOPHARYNGIOMA
0 40
5/15/96 –
11/18/96 – Revised
4/14/97 – Revised
BT-26 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN PATIENTS WITH CHOROID PLEXUS NEOPLASM
1 40
5/15/96 –
11/18/96 – Revised
4/14/97 – Revised
BT-27 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN PATIENTS WITH GERM CELL TUMOR OF THE BRAIN
0 40
5/15/96 –
11/18/96 – Revised
4/14/97 – Revised
BT-28 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN PATIENTS WITH MENINGIOMA
2 40
5/17/96 –
9/10/96 – Revised
4/14/97 – Revised
CAN-1 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH REFRACTORY MALIGNANCIES
133 133
7/11/96 – Revised
CO-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH ADENOCARCINOMA OF THE COLON
12 40
7/9/96 – Revised
9/7/96 – Revised
(RE-2 was added to this Protocol)
4/14/97 – Revised
CO-3 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 CAPSULES IN PATIENTS WITH ADENOCARCINOMA OF THE COLON
4 40
8/12/96 – Revised
12/2196 – Revised
ES-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH ADENOCARCINOMA OF THE
ESOPHAGUS
4 40
7/9/96 – Revised
9/10/96 – Revised
10/30/96 – Revised
4/14/97 – Revised
HB-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH HEPATOBLASTOMA
7/8/96 – Revised
9/10/96 – Revised
3/2/97 – Revised
4/14/97 – Revised
HE-2 PHASE II STUDY OF ANTINEOPLASTONS A10 IN PATIENTS WITH PRIMARY LIVER CANCER
1 40
2/12/97 – Origination date
5/28/97 – Revised
HN-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE HEAD AND NECK
6 40
7/9/96 – Revised
9/10/96 – Revised
11/6/96 – Revised
added Children’s Informed Consent,
Revised 4/14/97 –
LA-3 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH ADENOCARCINOMA OF THE LUNG
13 40
7/20/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
6/26/97 – Revised
LA-4 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH LARGE CELL, UNDIFFERENTIATED CARCINOMA OF THE LUNG
4 40
7/20/96 – Revised
9/28/96 – Revised
12/11/96 – Revised
4/14/97 – Revised
LA-5 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH BRONCHIAL ALVEOLAR CARCINOMA OF THE LUNG
1 40
7/20/96 – Revised
9/28/96 – Revised
12/11/96 – Revised
4/14/97 – Revised
LA-6 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH SQUAMOUS CELL CARCINOMA OF THE LUNG
5 40
7/26/96 – Revised
10/4/96 – Revised
4/14/97 – Revised
LA-7 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH SMALL CELL CARCINOMA OF THE LUNG
2 40
7/20/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
LA-10 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 CAPSULES IN PATIENTS WITH NON SMALL CELL LUNG CANCER
9 40
8/12/96 – Revised
9/9/96 – Revised
12/9/96 – Revised
LY-3 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH NON-HODGKIN’S LYMPHOMA
2 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
LY-6 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH NON-HODGKIN’S LYMPHOMA, LOW GRADE
18 40
6/22/96 – Revised
8/12/96 – Revised
9/28/96 – Revised
10/23/96 – Revised
5/11/97 – Revised
LY-7 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH NON-HODGKIN’S LYMPHOMA, INTERMEDIATE GRADE
10 40
6/22/96 – Revised
8/12/96 – Revised
9/28/96 – Revised
10/23/96 – Revised
4/14/97 – Revised
LY-8 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH NON-HODGKIN’S LYMPHOMA, HIGH GRADE
1 40
6/22/96 – Revised
5/11/96 – Revised
LY-9 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH MANTLE ZONE LYMPHOMA
4 40
6/22/96 – Revised
9/10/96 – Revised
4/14/97 – Revised
LY-10 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 WITH CHRONIC MYELOGENOUS LEUKEMIA
0 40
10/4/96 – Revised
4/14/97 – Revised
LY-11 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH MYCOSIS FUNGOIDES – SEZARY SYNDROME
0 40
9/10/96 – Revised
4/14/97 – Revised
LY-12 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA
0 40
9/10/96 – Revised
4/14/97 – Revised
LY-13 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH PRIMARY LYMPHOMA OF THE GASTROINTESTINAL TRACT
0 40
9/10/96 – Revised
4/14/97 – Revised
LY-14 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 INFUSIONS IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
5/22/96 – Revised
9/18/96 – Revised
12/9/96 – Revised
4/14/97 – Revised
MA-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH MESOTHELIOMA
4 40
7/8/96 – Revised
9/10/96 – Revised
4/14/97 – Revised
ME-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH MALIGNANT MELANOMA
8 40
7/26/96 – Revised
10/4/96 – Revised
4/14/97 – Revised
MF-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH MALIGNANT FIBROUS HISTIOCYTOMA
0 40
6/1997
MM-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH MULTIPLE MYELOMA
5 40
7/26/96 – Revised
10/2/96 – Revised
MW-2 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH MACROGLOBULINEMIA OF WALDESTROM
0 40
7/26/96 – Revised
10/4/96 – Revised
4/14/97 – Revised
NB-2 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH NEUROBLASTOMA
1 40
Orig: Dec 6, 1996
2/13/97 – Revised
4/14/97 – Revised
NE-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH NEUROENDOCRINE TUMORS
3 40
7/9/96 – Revised
9/10/96 – Revised
4/14/97 – Revised
OV-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE OVARY
5 40
7/20/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
PA-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE PANCREAS
11 40
7/20/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
PN-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH PRIMITIVE NEUROECTODERMAL TUMOR OUTSIDE THE CENTRAL NERVOUS SYSTEM
1 40
Orig: Dec 6, 1996
2/10/97 – Revised
4/14/97 – Revised
PR-4 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH ADENOCARCINOMA OF THE PROSTATE
11 40
7/5/96 – Revised
10/3/96 – Revised
7/9/97 – Revised
10/14/97 – Revised
PR-5 PHASE II STUDY OF ADENOCARCINOMA OF THE PROSTATE WITH ANTINEOPLASTON A10 AND AS2-1 CAPSULES
16 40
5/16/96 – Revised
7/29/96 – Revised
10/3/96 – Revised
10/14/97 – Revised
PR-6 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 CAPSULES IN COMBINATION WITH TOTAL ANDROGEN BLOCKADE IN PATIENTS WITH ADENOCARCINOMA OF THE PROSTATE
0 40
8/1/97;
8/25/97 – Revised
PR-8 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH ADENOCARCINOMA OF THE PROSTATE
0 40
7/5/96 – Revised
9/10/96 – Revised
4/14/97 – Revised
10/14/97 – Revised
RN-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE KIDNEY
9 40
7/20/96 – Revised
9/28/96 – Revised
10/25/96 – Revised
4/14/97 – Revised
SA-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH SOFT TISSUE SARCOMA
8 40
7/8/96 – Revised
9/10/96 – Revised
4/14/97 – revised
SI-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE SMALL INTESTINE
1 40
7/9/96 – Revised
9/10/96 – Revised
4/14/97 – Revised
ST-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH ADENOCARCINOMA OF THE STOMACH
6 40
7/8/96 – Revised
9/10/96 – Revised
4/14/97 – Revised
UC-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE UTERINE CERVIX AND/OR VULVA
8 40
7/20/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
UP-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF AN UNKNOWN PRIMARY
6 40
7/8/96 – Revised
9/10/96 – Revised
4/14/97 – Revised
WT-2 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH WILMS’ TUMOR
2 40
7/8/96 – Revised
9/10/96 – Revised
4/14/97 – Revised
3/1/1997 Company entered into research funding agreement with Burzynski and terminated all royalty, rent, administrative services and supply agreements entered into 1/23/1992
Under research funding agreement Company agrees to undertake all scientific research in connection with development of new or improved Antineoplastons for treatment of cancer and other diseases
Company will hire personnel as required to fulfill obligation
Burzynski agrees to fund all basic research Company undertakes in connection with development of other Antineoplastons or refinements to existing Antineoplastons for treatment of cancer and other diseases
Burzynski agrees to pay expenses to conduct clinical trials
Burzynski agrees to provide Company laboratory and research space and office space at no charge
Burzynski may fulfill obligation in part by providing administrative staff for Company to manage business, at no cost
Burzynski agrees to pay full amount of monthly and annual budget or expenses for operation together with unanticipated but necessary expenses which Company incurs
3/1/1997 Company entered into research funding agreement with Burzynski and terminated all aforementioned agreements
term of Research Funding Agreement is one year, and automatically renewable for 3 additional one year terms, unless one party notifies other at least 90 days prior to expiration of term of agreement of intention not to renew agreement
In addition to termination provisions, agreement automatically terminates in event Burzynski owns less than 50% of outstanding shares of Company, or removed as President and/or Chairman of Board of Company, unless notifies in writing of intention to continue agreement notwithstanding automatic termination provision
Pursuant to Research Funding Agreement:
o Company agreed to undertake all scientific research in connection with development of new or improved Antineoplastons for treatment of cancer and other diseases
Company will hire personnel required to fulfill obligations under agreement
o Burzynski agreed to fund in entirety all basic research which Company undertakes in connection with development of other Antineoplastons or refinements to existing Antineoplastons for treatment of cancer and other diseases
o Burzynski agreed to pay expenses to conduct clinical trials
o Burzynski agreed to provide laboratory and research space, office space at facility, at no charge
o parties agreed Burzynski may fulfill obligations in part by providing administrative staff to manage business, at no cost
o Burzynski agreed to pay full amount of monthly and annual budget or expenses for operation of Company, together with other unanticipated but necessary expenses which Company incurs
Payments from Burzynski to Company of monthly budget made in 2 equal installments on 1st and 15th of each month
3/25/1997 Company and Burzynski entered into Royalty Agreement amended 9/29/1997, pursuant to which Burzynski agreed to act as principal clinical investigator of clinical trials necessary for obtaining FDA approval for interstate marketing and distribution of Antineoplastons
Payments made to Burzynski for 20% of cost of chemicals used in clinical trials being conducted by Burzynski 3/1/1996 – 2/28/1997
Burzynski is acting as principal investigator during clinical trials pursuant to 3/25/1997 Royalty Agreement between Company and Burzynski
11/25/1997 – Company sponsoring 72 Phase II clinical trials conducted pursuant to INDs filed with FDA which are currently ongoing
12/10/1997
http://www.siliconinvestor.com/readmsg.aspx?msgid=2965068
Burzynski Research Institute Advances Clinical Trials for New Cancer Treatment and Completes New SEC Filing
HOUSTON–(BUSINESS WIRE)
12/10/1997–Burzynski Research Institute Inc.
Company announced new clinical trial earlier this year for experimental drugs, ANTINEOPLASTONS, for treatment of liver cancer
Company plans to submit results of current clinical trials to FDA 1/1998
If FDA finds results of trials sufficiently promising, Burzynski Research Institute Inc. will initiate procedure to generate data which will support New Drug Application (NDA)
BRI retained services of Brewer-Gruenert Capital Advisors, L.L.C., in Houston, to guide Company in preparing for expected growth based upon expectations of positive results of latest round of clinical trials
currently conducting approximately 72 FDA approved clinical trials
12/10/1997 – Burzynski Research Institute is sponsoring 72 Phase II Clinical Trials of ANTINEOPLASTONS in treatment of variety of cancer types and advanced stages
Early clinical results indicate particular promise with malignant brain tumors and lymphomas
interim analysis of 3 clinical studies indicates that 33% to 50% of evaluable brain tumor patients accomplished either complete tumor elimination or reduction of tumor size by more than 50%
5/31/2000
http://www.sec.gov/Archives/edgar/data/724445/0000912057-01-514477.txt
5/31/2000 5/31/1999
10QSB
5/31/2000 – CONFORMED PERIOD OF REPORT
5/11/2001 – FILED AS OF DATE
STANDARD INDUSTRIAL CLASSIFICATION:
IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835]
5/31/2000 – quarterly period ended
currently conducting clinical trials on various Antineoplastons in accordance with FDA regulations
significant portion of Burzynski’s patients are admitted and treated as part of clinical trial programs which are regulated by FDA
Company currently conducting 72 FDA approved clinical trials
5/31/2001 (7/12/2001)
http://www.sec.gov/Archives/edgar/data/724445/0000912057-01-523630.txt
CONFORMED PERIOD OF REPORT: 5/31/2001
FILED AS OF DATE: 7/12/2001
10QSB
Company is currently conducting clinical trials on various antineoplastons in accordance with FDA regulations, however, at this time none of antineoplaston drugs have received FDA approval
significant portion of Burzynski’s patients are admitted and treated as part of clinical trial programs regulated by FDA
Company believes Antineoplastons are useful in treatment of human cancer and other diseases of body and is currently conducting Phase II clinical trials of Antineoplastons
Burzynski’s medical practice has
successfully funded Company’s research activities over last 17 years and, in 1997, medical practice was expanded to include traditional cancer #Burzynskitreatment options such as chemotherapy, immunotherapy and hormonal therapy in response to FDA requirements that cancer patients utilize more traditional cancer treatment options in order to be eligible to participate in Antineoplaston clinical trials
As result of expansion of Burzynski’s medical practice, financial condition of medical practice has improved Burzynski’s ability to fund Company’s operations
Company currently conducting 72 FDA approved clinical trials
5/31/2002 – quarterly period ending
http://www.sec.gov/Archives/edgar/data/724445/0000912057-02-027187.txt
5/31/2002 – CONFORMED PERIOD OF REPORT
7/12/2002 – FILED AS OF DATE
FORM 10-QSB
Company is currently conducting clinical trials on various antineoplastons in accordance with FDA regulations
A significant portion of Burzynski’s patients are admitted and treated as part of clinical trial programs which are regulated by FDA
Company is currently conducting approximately 72 FDA approved clinical trials
1/14/2003 – Filing Date
11/30/2002 – Period of Report
Click to access 0001047469-03-001370.pdf
currently conducting clinical trials on various antineoplastons in accordance with FDA regulations
currently conducting approximately 72 FDA approved clinical trials
Drugs in R & D (Drugs in Research and Development)
2003 – 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/m/pubmed/12718563
Drugs R D. 2003;4(2):91-101
6 months median duration of treatment
of all 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 were observed, which included
3 cases of skin allergy
2 cases of:
anaemia
fever
hypernatraemuia
single cases of:
agranulocytosis
hypoglycaemia
numbness
tiredness
myalgia
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
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/m/pubmed/15563234
Drugs R D. 2004;5(6):315-26
incurable recurrent and progressive multicentric glioma
antineoplaston A10 and AS2-1 (ANP)
9 – patients’ median age
6 patients were diagnosed with pilocytic astrocytoma
4 with low-grade astrocytoma
1 with astrocytoma grade 2
1 case of visual pathway glioma, a biopsy was not performed due to a dangerous location
16 months – The average duration of intravenous ANP therapy
19 months – The average duration of oral ANP
1 patient was non-evaluable due to only 4 weeks of ANP and lack of follow-up scans
1 patient who had stable disease discontinued ANP against medical advice and died 4.5 years later
10 patients are alive and well from 2 to >14 years post-diagnosis
Only 1 case of serious toxicity of reversible tinnitus, of 1 day’s duration, was described
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
11/10/2004
http://www.sec.gov/Archives/edgar/data/724445/000104746904033767/0001047469-04-033767.txt
Burzynski Research Institute, Inc., announced signing Financial Advisory and Consulting Agreement with Millennium Energy Ventures.com, LLC (“MEVCO”)
Agreement provides BRI with access to MEVCO’s advisory services related to manufacturing realignment, pharmaceutical plant expansion, corporate focus and other consulting services to support FDA approval process for Antineoplastons A10 and AS2-1 for treatment of brain stem glioma
Press Release
11/9/2004
“Burzynski Research Institute, Inc. and Millennium Energy Ventures.com, LLC Sign Agreement
HOUSTON, TX
Burzynski Research Institute, Inc. and Houston based Millennium Energy Ventures.com, LLC, (MEVCO) announced today signing of Financial Advisory and Consulting Agreement that provides BRI with access to MEVCO’s advisory services related to manufacturing realignment, pharmaceutical plant expansion, corporate focus and other consulting services to support FDA approval process for Antineoplastons A10 and AS2-1 for treatment of brain stem glioma
This agreement is part of BRI’s strategy to facilitate fast track completion of necessary FDA approval process to bring treatment to the market place
Millennium EnergyVentures.com, LLC, is focused on providing financial and management expertise to technology-oriented growth companies in Energy and Medical sectors
firm focuses primarily on
energy technology markets including:
Enabling Technologies and Infrastructure, Power, Water, Communications, Oil and Gas, and Life Sciences
11/30/2005 – For the quarterly period ended
http://edgar.secdatabase.com/1472/95012906000296/filing-main.htm
significant portion of Burzynski’s patients are admitted and treated as part of clinical trial programs, regulated by FDA
Company is currently conducting 35 FDA-approved clinical trials
Drugs in R & D (Drugs in Research and Development)
3/2006 – Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive brainstem glioma
http://www.ncbi.nlm.nih.gov/m/pubmed/16484713
Integr Cancer Ther. 2006 Mar;5(1):40-7
Brainstem glioma carries the 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 is even more challenging when an inoperable tumor is 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 for a patient with anaplastic astrocytoma
5+ years for a patient with glioblastoma
39% – Progression-free survival at 6 months
5+ year survival in recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of the brainstem in a small group of patients
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 were assessed by gadolinium-enhanced magnetic resonance imaging and positron emission tomography
Antineoplastons tolerated very well
1 case of 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
5/31/2007 – quarterly period ended
http://edgar.secdatabase.com/1173/110465907054073/filing-main.htm
Company is currently conducting clinical trials on various Antineoplastons in accordance with FDA regulations
A portion of Burzynski’s patients are admitted and treated as part of clinical trial programs, which are regulated by FDA
currently conducting 27 FDA-approved clinical trials
Drugs in R & D (Drugs in Research and Development)
2007 – Recent clinical trials in diffuse intrinsic brainstem glioma
Review Article
http://www.cancer-therapy.org/CT/v5/B/HTML/42._Burzynski,_379-390.html
E. Multitargeted therapy
Antineoplaston A10 injections (A10) consist of synthetic phenylacetylglutaminate sodium (PG) and phenylacetylisoglutaminate sodium (isoPG) in a ratio 4:1
antineoplaston AS2-1 (AS2-1) consists of PG and phenylacetate sodium (PN) in a ratio of 1:4
Phase II studies with ANP included patients with DBSG began 1988
(Burzynski, 2004a)
Only small # of patients with DBSG involved in most studies, which dealt with broad spectrum of primary brain tumors
(Burzynski, 2004a)
1996, phase II study of ANP in patients with brainstem gliomas opened and nearing completion
(Burzynski et al, 2003, 2004a, 2007)
studies are conducted at Burzynski Clinic and monitored by FDA and Institutional Review Board (IRB)
most recent report describes results in children with newly diagnosed DBSG
(Burzynski et al, 2007)
20 evaluable patients
5 with high-grade gliomas
overall survival (OS)
2 years – 40%
5 years – 30%
CR – 30%
PR – 10%
SD – 20%
PD – 40%
(Burzynski et al, 2007)
study closed for accrual and final results will be evaluated before end of 2007
Phase III protocol currently under FDA’s review
Results summarized in Table 2
proposed antineoplastic activity of ANP in DBSG consists of targeted therapy affecting AKT2 and TGFB1 pathways (PG), RAS, TP53, and p21 (PN) MYCC (PG and PN), MAD (PG), INI1 (PG), and apoptosis (PG and isoPG)
PG is formed in patient’s liver from PN and PB, but doesn’t share with PN and PB an inhibitory affect on HDAC
details of these mechanisms have been described previously
(Castillo et al, 1991; Liau et al, 1992; Adam et al, 1995; Liu and Samid, 1995; Shack et al, 1995; Danesi et al, 1996; Gorospe et al, 1996; Prasanna et al, 1996; Adam et al, 1997; Engelhard et al, 1997; Harrison et al, 1998; Ng et al, 2000; Witzig et al, 2000; Li et al, 2001; Burzynski et al, 2003, 2004a,b, 2005; Waldbillig and Burzynski, 2003; Burzynski, 2004b, 2006a,b)
DBSGs remain some of most tragic diagnoses in oncology
general opinion of neuro-oncologists that results of treatment for DBSG constitute worst response in all primary brain tumors
DBSGs occur usually in children, in whom brain tumors in general are 2nd most frequent malignancy, and most common form of solid tumors
Due to poor response, # of clinical trials in DBSG is small, and there isn’t much interest in bringing new agents into approval process by pharmaceutical companies
Results of treatment with antineoplastons A10 and AS2-1 (ANP) in patients with diffuse, intrinsic brain stem glioma
Author – Burzynski et al, 2007
Phase II – Study Type
N – newly diagnosed tumor – Tumor Type
20 – # of patients
ANP – Treatment
ANP – antineoplastons A10 and AS2-1
Efficacy
overall survival
2 yrs / 5 yrs
40% / 30%
median survival time
16.4 – months
6 / 30% – # and % of Patients Showing Complete Response
2 / 10% – # and % of Patients Showing Partial Response
4 / 20% – # and % of Patients Showing Stable Disease
8 / 40% – # and % of Patients Showing Progressive Disease
Most results of phase II trials with targeted therapy and ANP have been presented at oncology meetings and published as abstracts
It was decided to include data from meeting abstracts in order to present most up to date results, but they should be treated with caution until they pass scrutiny of peer review
Children, older than 3 years, and young adults with newly diagnosed tumors, are usually temporarily helped with standard radiation therapy, but it’s estimated that less than 10% of them will survive 2 years
Children, younger than 3 years, adults after age 40, and patients with high-grade glioma pathology have very grave prognosis, and median survival is similar to supratentorial GBM, or worse
Children diagnosed with DBSG and neurofibromatosis 1 have better prognosis, except those that show contrast-enhancement on MRI
prognosis is especially grave for patients with recurrent DBSG, who typically don’t survive longer than 6 months
Targeted radiotherapy and bevacizumab in combination with irinotecan may offer hope, but they would require further clinical trials
The patients with recurrent DBSG can be helped with treatments currently in phase II clinical trials
The results of phase II trials in DBSG with ANP compare favorably with responses and survival data in radiation therapy and chemotherapy trials
Currently conducted phase II studies are closed for accrual and nearing completion, and phase III studies are scheduled to open soon
Introduction of new multitargeted agents and acceleration of basic and clinical research in DBSG may offer better chances in the future
http://www.wikinvest.com/stock/Burzynski_Research_Institute_(BZYR)/Liquidity_Capital_Resources
Since 2009, permission for final phase of FDA clinical testing to allow Antineoplastons to be “FDA-approved” has been granted
only obstacles now are $300 million $s needed to pay for final phase of clinical testing-and FDA requiring children with inoperable brainstem glioma to also undergo radiation treatment in Phase 3 trials, claiming it would be “unethical” not to do so
In 2009, Phase II FDA-supervised clinical trials of Antineoplastons successfully came to a close
Phase III trials are 3rd and final phase before reaching FDA approval
trials could begin worldwide in 2010, barring ability to raise money to fund them
FDA has officially mandated that some patients participating in these Phase III trials be subjected to radiation treatment while simultaneously receiving Antineoplaston treatment—claiming it would be “unethical” not to do so
1/13/2009 Burzynski Research Institute Gets SPA Clearance from the FDA to Initiate Pivotal Phase III Trial of Combination Antineoplaston Therapy and Radiation Therapy, Study to Evaluate Children with Newly-Diagnosed Diffuse Intrinsic Brainstem Glioma
EX-99.1 4 a09-2965_1ex99d1.htm EX-99.1
Exhibit 99.1
HOUSTON, TX – 1/13/2009 – Burzynski Research Institute, Inc. today announced its reached an agreement with US FDA that enables company to move forward immediately with pivotal Phase III clinical trial of combination antineoplaston therapy plus radiation therapy in patients with newly-diagnosed, diffuse, intrinsic brainstem glioma
Antineoplaston therapy (ANP) uses synthetic version of naturally occurring peptides and amino acid derivatives found in human body to target and control cancer cells without destroying normal cells
agreement was made under FDA’s Special Protocol Assessment (SPA) procedure and means that design and planned analysis of Phase III study is acceptable to support a regulatory submission seeking new drug approval
“We are very pleased by our agreement with the FDA to move forward with a confirmatory study on a type of tumor that has shown itself to be highly treatment resistant and challenged further by severely limited treatment options and clinical trials that could expand and discover new, efficacious therapies,”
said Burzynski
“The SPA agreement puts antineoplaston therapy further down a straight path to regulatory approval, enabling the kind of study that should prove its merits as another option to cancer management.”
“BRI has reached important milestone independently without financial backing from government, and without major pharmaceutical partner—a unique accomplishment in the oncology field
From inception, we’ve been committed to developing a targeted gene therapy option that’s less aggressive on the body than conventional therapies and have made considerable progress on steps mandated by FDA to bring a new drug to a patient community and cancer type that has unmet needs.”
About Phase III study
primary objective of randomized study is to compare overall survival of children with newly-diagnosed diffuse intrinsic brainstem glioma (DBSG) who receive combination antineoplaston therapy [Antineoplastons A10 (Atengenal) & AS2-1 (Astugenal)] plus radiation therapy (RT) versus RT alone
DBSG are considered to be 1 of most difficult types of cancer to treat
It combines highly malignant characteristics with very difficult location of brainstem
DBSG are inoperable because they involve most of brainstem (diffuse and intrinsic)
Number of children in US with brainstem gliomas is approximately 660
Absent treatment, survival rate from time of diagnosis is 6 months or less
At present, there are no standard curative treatments for the disease
RT is only treatment that may slow its progress, but at 2 years 93% of children with this type of cancer die, and none survive for 5 years
Other conventional treatments such as chemotherapy have generally been tried in clinical trials but are shown to be ineffective
There are no pharmacological treatments approved for DBSG at this time
Research and development efforts are focused on basic ANP research and 19 Phase II clinical trials
http://www.sec.gov/Archives/edgar/data/0000724445/000110465909043323/0001104659-09-043323-index.htm
For quarterly period ended 5/31/2009
5/31/2009 – Period of Report
7/15/2009 – Filing Date Changed
Form 10-Q
12/2/2008 Company announced orphan drug designation of Antineoplastons A10 and AS2-1 was expanded to treatment of all gliomas
Company is currently conducting clinical trials on various Antineoplastons in accordance with FDA regulations
portion of Burzynski’s patients are admitted and treated as part of clinical trial programs, which are regulated by FDA
Company is currently conducting 12 FDA-approved clinical trials
http://www.sec.gov/Archives/edgar/data/0000724445/000110465909059014/0001104659-09-059014-index.htm
quarterly period ended 8/31/2009
8/31/2009 – Period of Report
10/15/2009 – Filing Date Changed
Form 10-Q – Quarterly report
9/9/2009 Company entered into Clinical Study Agreement with University of Alabama at Birmingham pursuant to which Company retained University to provide following services in connection with clinical trials of Antineoplastons:
develop and implement statistical plans
analyze and manage data
review and amend Case Report Forms (CRFs)
prepare statistical reports for Data Safety Monitoring Boards (DSMB) and US FDA
services will be performed for certain protocols listed in Agreement
Agreement will terminate at completion of protocols listed in Agreement, however, either party may terminate Agreement, with or without cause, by giving 30 calendar days’ prior written notice
5/1/2007 – 8/31/2009 – $24,641 – Company paid University for services previously provided which was accrued during 3 month period ended 8/31/2009
Subsequent services are billed to Company on monthly basis
All rights, title and interest in all data and reports generated in performance of services, pursuant to Agreement, are sole and exclusive property of Company
Company intends to enter into clinical development agreement with contract research organization for services relating to Phase III clinical study, including initially a feasibility analysis of patient enrollment and site requirements of planned study
Company is currently conducting clinical trials on various Antineoplastons in accordance with FDA regulations
portion of Burzynski’s patients are admitted and treated as part of clinical trial programs, which are regulated by FDA
Company is currently conducting 12 FDA-approved clinical trials
http://www.sec.gov/Archives/edgar/data/0000724445/000110465910031825/0001104659-10-031825-index.htm
fiscal year ended 2/28/2010
2/28/2010 – Period of Report
6/1/2010 – Filing Date Changed
Form 10-K
Burzynski has developed 6 formulations of natural Antineoplastons and 6 synthetic formulations of Antineoplastons
All Phase II clinical trials currently sponsored by Company involve use of 4 formulations of synthetic Antineoplastons known as A10 and AS2-1 in capsules and injections
Company is also conducting laboratory research involving new generations of Antineoplastons A10 and AS2-1
Orphan Drug Designation
9/7/2004 FDA granted “orphan drug” status to Company’s Antineoplastons under Orphan Drug Act of 1983
In enacting Orphan Drug Act of 1983, Congress sought to provide incentives to promote development of drugs for treatment of rare diseases
drug may be considered for orphan drug designation if drug is intended to treat rare disease or condition affecting fewer than 200,000 people in US or, even if drug treats a disease affecting more than 200,000 people in US, drug isn’t expected to be profitable from sales in US
Subject to applicable laws and regulations, 1st sponsor to obtain FDA marketing approval for a drug with orphan drug designation for designated disease or condition receives limited marketing exclusivity for 7 years; no other sponsor may bring to market “same drug” for treatment of same disease or condition for period of 7 years from date application is approved by FDA
drug with orphan drug designation must meet same criteria for safety and efficacy as drug without orphan drug designation
Company began Phase II clinical studies in 1994 with 4 studies
At that time, a number of patients were also receiving Antineoplastons at Burzynski’s clinic in Houston, Texas (the “Burzynski Clinic”) outside clinical trials
2/23/1996 FDA requested that all then-current patients of Burzynski Clinic desiring to continue Antineoplaston treatment be admitted to Phase II Study, according to Protocol CAN-1
http://www.sec.gov/Archives/edgar/data/0000724445/000110465910038168/0001104659-10-038168-index.htm
quarterly period ended 5/31/2010
5/31/2010 – Period of Report
7/15/2010 – Filing Date Changed
Form 10-Q
Company is primarily engaged as research and development facility for Antineoplaston drugs being tested for use in treatment of cancer
Company is currently conducting clinical trials on various Antineoplastons in accordance with FDA regulations
9/2004 Company announced FDA awarded orphan drug status to Antineoplastons A10 and AS2-1 for treatment of brainstem glioma
2008 FDA awarded orphan drug status to Antineoplastons A10 and AS2-1 for the treatment of all glioma
http://www.sec.gov/Archives/edgar/data/0000724445/000110465910001658/0001104659-10-001658-index.htm
quarterly period ended 11/30/2009
11/30/2009 – Period of Report
1/14/2010 – Filing Date Changed
Form 10-Q
Company is currently conducting clinical trials on various Antineoplastons in accordance with FDA regulations
9/2004 Company announced FDA awarded orphan drug status to Antineoplastons A10 and AS2-1 for treatment of brainstem glioma
During 2008, FDA awarded orphan drug status to Antineoplastons A10 and AS2-1 for treatment of all gliomas
portion of Burzynski’s patients are admitted and treated as part of clinical trial programs, which are regulated by FDA
Company is currently conducting 12 FDA-approved clinical trials
http://www.sec.gov/Archives/edgar/data/0000724445/000110465910038168/0001104659-10-038168-index.htm
quarterly period ended 5/31/2010
5/31/2010 – Period of Report
7/15/2010 – Filing Date Changed
Form 10-Q
portion of Burzynski’s patients are admitted and treated as part of clinical trial programs regulated by FDA
Company believes Antineoplastons are useful in treatment of human cancer and currently conducting Phase II clinical trials of Antineoplastons relating to treatment of cancer
Upon completion of assessment, randomized, international phase III study will commence
9/2004 Company announced FDA awarded orphan drug status to Antineoplastons A10 and AS2-1 for treating patients with brainstem gliomas
1/13/2009 Company announced Company had reached an agreement with FDA for Company to move forward with pivotal Phase III clinical trial of combination Antineoplaston therapy plus radiation therapy in patients with newly diagnosed, diffuse, intrinsic brainstem gliomas (DBSG)
agreement was made under FDA’s Special Protocol Assessment procedure, meaning design and planned analysis of Phase III study is acceptable to support regulatory submission seeking new drug approval
2/1/2010 Company entered into agreement with Cycle Solutions, Inc., dba ResearchPoint to initiate and manage pivotal Phase III clinical trial of combination Antineoplastons A10 and AS2-1 plus radiation therapy (RT) in patients with newly-diagnosed, diffuse, intrinsic brainstem glioma
ResearchPoint is currently conducting feasibility assessment
ResearchPoint has secured interest and commitment from number of sites selected
Upon completion of assessment, randomized, international phase III study will commence
study’s objective is to compare overall survival of children with newly-diagnosed DBSG who receive combination Antineoplastons A10 and AS2-1 plus RT versus RT alone
Company is currently conducting 5 FDA-approved clinical trials
8/31/2010 (10/15/2010) 10-Q
http://edgar.secdatabase.com/541/110465910052441/filing-main.htm
8/31/2010 quarterly period ended
Company is currently conducting 5 FDA-approved clinical trials
A10 & AS2-1 in children w/high grade glioma
19 – Ptnts Accrued
11 – Evaluable Ptnts
1 / 19.1% – #&% of Ptnts Show Complete Resp
3 / 27.3% – #&% of Ptnts Show Partial Resp
3 / 27.3% / #&% of Ptnts Show Stable Disease
4 / 36.4% – #&% of Ptnts Show Progress Disease
Certain prospective protocols which have reached a Milestone as of May 1, 2012
The results of Protocols
BT-06
BT-07
BT-08
BT-09
BT-10
BT-11
BT-12
BT-13
BT-15
BT-18
BT-20
BT-21
BT-22
BT-23
are set forth below (as of May 1, 2012)
A Randomized Study of Antineoplaston Therapy vs. Temozolomide in Subjects With Recurrent and / or Progressive Optic Pathway Glioma
Optic Nerve Glioma
Drug: Temozolomide
Drug: Antineoplaston A10 and Antineoplaston AS2-1 (ANP)
Phase 3
ClinicalTrials.gov Identifier:
NCT01260103
“Optic Pathway Glioma”
5% of all childhood tumors
http://www.ncbi.nlm.nih.gov/m/pubmed/22607912
Today is “Rare Disease” Day
http://rarediseases.info.nih.gov/GARD/Condition/4107/Optic_pathway_glioma.aspx
NCT01260103 (BRI-BT-54)
http://www.clinicaltrials.gov/ct2/show/record/NCT01260103?term=Burzynski&rank=61
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 Patients With Stage IV Adrenal Gland Cancer
Adrenocortical Carcinoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
ACTIVE
Age 6 months and over
Protocol IDs
CDR0000066485
BC-AD-2, NCT00003453
http://cancer.gov/clinicaltrials/BC-AD-2
Antineoplaston Therapy in Treating Women With Stage IV Breast Cancer
Breast Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066486
BC-BR-12, NCT00003454
http://cancer.gov/clinicaltrials/BC-BR-12
Antineoplaston Therapy in Treating Women With Advanced Breast Cancer
Stage IV Breast Cancer
Recurrent Breast Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Procedure: alternative product therapy
Procedure: biological therapy
Procedure: biologically based therapies
Procedure: cancer prevention intervention
Procedure: complementary and alternative therapy
Procedure: differentiation therapy
Phase 2
NCT00003455
CDR0000066487, BC-BR-14
THIS STUDY HAS BEEN WITHDRAWN PRIOR TO ENROLLMENT
Antineoplaston Therapy in Treating Patients With Glioblastoma Multiforme
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066488
BRI-BT-7, NCT00003456
http://cancer.gov/clinicaltrials/BRI-BT-7
· Protocol BT-07, involving the study of Antineoplastons A10 and AS2-1 in patients with glioblastoma multiforme, not treated with radiation therapy or chemotherapy
BT-07 – Protocol #
40 – Patients Accrued
24 – Evaluable Patients
2 / 8.3% – # and % of Patients Showing Complete Response
1 / 4.2% – # and % of Patients Showing Partial Response
3 / 12.5% – # and % of Patients Showing Stable Disease
18 / 75.0% – # and % of Patients Showing Progressive Disease
Antineoplaston Therapy in Treating Patients With Brain Tumors
Brain and Central Nervous System Tumors
Drug: antineoplaston
Drug: antineoplaston AS2-1
Phase 2
Phase II
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
Antineoplaston Therapy in Treating Children With Brain Tumors
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
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
Antineoplaston Therapy in Treating Patients With Brain Stem Glioma
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
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
Antineoplaston Therapy in Treating Children With Primitive Neuroectodermal Tumors
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
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
Antineoplaston Therapy in Treating Children With Low-Grade Astrocytoma
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
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
Antineoplaston Therapy in Treating Children With Rhabdoid Tumor of the Central Nervous System
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 6 months to 17 years
Protocol IDs
CDR0000066505
BC-BT-14, NCT00003469
http://cancer.gov/clinicaltrials/BC-BT-14
Antineoplaston Therapy in Treating Patients With Anaplastic Astrocytoma
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
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
Antineoplaston Therapy in Treating Patients With Low-Grade Astrocytoma
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066508
BC-BT-16, NCT00003471
http://cancer.gov/clinicaltrials/BC-BT-16
Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Oligodendroglioma
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
Closed
Age 18 and over
Phase 2
Phase II
CLOSED
Protocol IDs
CDR0000066509
BC-BT-17, NCT00003472
http://cancer.gov/clinicaltrials/BC-BT-17
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 2
Phase II
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
Antineoplaston Therapy in Treating Patients With Glioblastoma Multiforme
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066511
BRI-BT-20, NCT00003474
http://cancer.gov/clinicaltrials/BRI-BT-20
· Protocol BT-20, involving the study of Antineoplastons A10 and AS2-1 in patients with glioblastoma multiforme, which recurred after standard radiation and/or chemotherapy
BT-20 – Protocol #
40 – Patients Accrued
22 – Evaluable Patients
1 / 4.5% – # and % of Patients Showing Complete Response
1 / 4.5% – # and % of Patients Showing Partial Response
12/ 54.5% – # and % of Patients Showing Stable Disease
8 / 36.4% – # and % of Patients Showing Progressive Disease
Antineoplaston Therapy in Treating Patients With Primary Malignant Brain Tumors
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
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
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
Antineoplaston Therapy in Treating Patients With Ependymoma
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 6 months and over
Protocol IDs
CDR0000066516
BC-BT-24, NCT00003479
http://cancer.gov/clinicaltrials/BC-BT-24
Antineoplaston Therapy in Treating Patients With Meningioma
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066521
BC-BT-28, NCT00003483
http://cancer.gov/clinicaltrials/BC-BT-28
Antineoplaston Therapy in Treating Patients With Metastatic or Unresectable Colon Cancer
Colorectal Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066523
BC-CO-2, NCT00003485
http://cancer.gov/clinicaltrials/BC-CO-2
Antineoplaston Therapy in Treating Patients With Colon Cancer
Stage IV Colon Cancer
Recurrent Colon Cancer
Adenocarcinoma of the Colon
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Procedure: alternative product therapy
Procedure: biological therapy
Procedure: biologically based therapies
Procedure: cancer prevention intervention
Procedure: complementary and alternative therapy
Procedure: differentiation therapy
Phase 2
NCT00003486
CDR0000066524, BC-CO-3
THIS STUDY HAS BEEN WITHDRAWN PRIOR TO ENROLLMENT
Antineoplaston Therapy in Treating Patients With Cancer of the Esophagus
Esophageal Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
NCT00003487
CDR0000066525, BC-ES-2
THIS STUDY HAS BEEN TERMINATED (Withdrawn due to slow enrollment)
Antineoplaston Therapy in Treating Patients With Advanced Head and Neck Cancer
Head and Neck Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 16 and over
Protocol IDs
CDR0000066527
BC-HN-2, NCT00003489
http://cancer.gov/clinicaltrials/BC-HN-2
Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer
Lung Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Phase 2
Closed
Protocol IDs
CDR0000066530
BC-LA-3, NCT00003491
http://cancer.gov/clinicaltrials/BC-LA-3
Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer
Lung Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066531
BC-LA-4, NCT00003492
http://cancer.gov/clinicaltrials/BC-LA-4
Antineoplaston Therapy in Treating Patients With Recurrent or Stage IV Lung Cancer
Lung Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066533
BC-LA-5, NCT00003494
http://cancer.gov/clinicaltrials/BC-LA-5
Antineoplaston Therapy in Treating Patients With Recurrent or Stage IV Lung Cancer
Lung Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
Age 18 and over
CLOSED
Protocol IDs
CDR0000066534
BC-LA-6, NCT00003495
http://cancer.gov/clinicaltrials/BC-LA-6
Antineoplaston Therapy in Treating Patients With Recurrent or Extensive-Stage Small Cell Lung Cancer
Lung Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066535
BC-LA-7, NCT00003496
http://cancer.gov/clinicaltrials/BC-LA-7
Antineoplaston Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer
Lung Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
Closed
Age 18 and over
Phase 2
CLOSED
Protocol IDs
CDR0000066536
BC-LA-10, NCT00003497
http://cancer.gov/clinicaltrials/BC-LA-10
Antineoplaston Therapy in Treating Patients With Non-Hodgkin’s Lymphoma
Lymphoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066537
BC-LY-3, NCT00003498
http://cancer.gov/clinicaltrials/BC-LY-3
Antineoplaston Therapy in Treating Patients With Low-Grade Non-Hodgkin’s Lymphoma
Lymphoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066538
BC-LY-6, NCT00003499
http://cancer.gov/clinicaltrials/BC-LY-6
Antineoplaston Therapy in Treating Patients With Refractory or Recurrent Intermediate-Grade Stage II, Stage III, or Stage IV Non-Hodgkin’s Lymphoma
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066540
BC-LY-7, NCT00003500
http://cancer.gov/clinicaltrials/BC-LY-7
Antineoplaston Therapy in Treating Patients With Recurrent or Refractory High-Grade Stage II, Stage III, or Stage IV Non-Hodgkin’s Lymphoma
Lymphoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066541
BC-LY-8, NCT00003501
http://cancer.gov/clinicaltrials/BC-LY-8
Antineoplaston Therapy in Treating Patients With Mantle Cell Lymphoma
Contiguous Stage II Mantle Cell Lymphoma
Noncontiguous Stage II Mantle Cell Lymphoma
Stage III Mantle Cell Lymphoma
Stage IV Mantle Cell Lymphoma
Recurrent Mantle Cell Lymphoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Procedure: alternative product therapy
Procedure: biological therapy
Procedure: biologically based therapies
Procedure: cancer prevention intervention
Procedure: complementary and alternative therapy
Procedure: differentiation therapy
Phase 2
NCT00003502
CDR0000066542, BC-LY-9
THIS STUDY HAS BEEN WITHDRAWN PRIOR TO ENROLLMENT
Antineoplaston Therapy in Treating Patients With Primary Central Nervous System Lymphoma
Primary Central Nervous System Lymphoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Procedure: alternative product therapy
Procedure: biological therapy
Procedure: biologically based therapies
Procedure: cancer prevention intervention
Procedure: complementary and alternative therapyuuhnp
Procedure: differentiation therapy
Phase 2
NCT00003505
CDR0000066545, BC-LY-12
THIS STUDY HAS BEEN WITHDRAWN PRIOR TO ENROLLMENT
Antineoplaston Therapy in Treating Patients With Primary Central Nervous System Lymphoma
Malignant Mesothelioma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
NCT00003508
CDR0000066551, BC-MA-2
THIS STUDY HAS BEEN TERMINATED (Withdrawn due to slow enrollment)
Antineoplaston Therapy in Treating Patients With Stage IV Melanomau
Melanoma (Skin)
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
COMPLETED
Age 18 and over
Protocol IDs
CDR0000066552
BC-ME-2, NCT00003509
http://cancer.gov/clinicaltrials/BC-ME-2
COMPLETED
Antineoplaston Therapy in Treating Patients With Multiple Myeloma
Multiple Myeloma and Plasma Cell Neoplasm
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066554
BC-MM-2, NCT00003511
http://cancer.gov/clinicaltrials/BC-MM-2
Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom’s Macroglobulinemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066555
BC-MW-2, NCT00003512
http://cancer.gov/clinicaltrials/BC-MW-2
Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory
Neuroblastoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 6 months and over
Protocol IDs
CDR0000066556
BC-NB-2, NCT00003513
http://cancer.gov/clinicaltrials/BC-NB-2
Antineoplaston Therapy in Treating Patients With Neuroendocrine Tumor That Is Metastatic or Unlikely to Respond to Surgery or Radiation Therapy
Merkel Cell Carcinoma
Islet Cell Carcinoma
Neuroendocrine Carcinoma
Pituitary Tumor
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Procedure: alternative product therapy
Procedure: biological therapy
Procedure: biologically based therapies
Procedure: cancer prevention intervention
Procedure: complementary and alternative therapy
Procedure: differentiation therapy
Phase 2
NCT00003514
CDR0000066557, BC-NE-2
THIS STUDY HAS BEEN WITHDRAWN PRIOR TO ENROLLMENT
Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors
Sarcoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 6 months and over
Protocol IDs
CDR0000066558
BC-PN-2, NCT00003515
http://cancer.gov/clinicaltrials/BC-PN-2
Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer
Prostate Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066559
BC-PR-5, NCT00003516
http://cancer.gov/clinicaltrials/BC-PR-5
Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer
Adenocarcinoma of the Prostate
Stage III Prostate Cancer
Stage IV Prostate Cancer
Recurrent Prostate Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Drug: bicalutamide
Drug: flutamide
Drug: leuprolide acetate
Procedure: alternative product therapy
Procedure: antiandrogen therapy
Procedure: biological therapy
Procedure: biologically based therapies
Procedure: cancer prevention intervention
Procedure: complementary and alternative therapy
Procedure: differentiation therapy
Procedure: endocrine therapy
Procedure: hormone therapy
Phase 2
NCT00003517
CDR0000066560, BC-PR-6
THIS STUDY HAS BEEN WITHDRAWN PRIOR TO ENROLLMENT
Antineoplaston Therapy in Treating Patients With Stage IV Kidney Cancer
Kidney Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066564
BC-RN-2, NCT00003520
http://cancer.gov/clinicaltrials/BC-RN-2
Antineoplaston Therapy in Treating Patients With Soft Tissue Sarcoma
Sarcoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 6 months and over
Protocol IDs
CDR0000066565
BC-SA-2, NCT00003521
http://cancer.gov/clinicaltrials/BC-SA-2
Antineoplaston Therapy in Treating Patients With Cancer of the Small Intestine
Small Intestine Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066566
BC-SI-2, NCT00003522
http://cancer.gov/clinicaltrials/BC-SI-2
Antineoplaston Therapy in Treating Patients With Stomach Cancer
Gastric Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066568
BC-ST-2, NCT00003524
http://cancer.gov/clinicaltrials/BC-ST-2
Antineoplaston Therapy in Treating Patients With Stage IV Cancer of the Cervix and/or Vulva
Cervical Cancer
Vulvar Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066569
BC-UC-2, NCT00003525
http://cancer.gov/clinicaltrials/BC-UC-2
Antineoplaston Therapy in Treating Patients With Cancer of Unknown Primary Origin
Carcinoma of Unknown Primary
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase
Phase II
CLOSED
Age 6 months and over
Protocol IDs
CDR0000066570
BC-UP-2, NCT00003526
http://cancer.gov/clinicaltrials/BC-UP-2
Antineoplaston Therapy in Treating Patients With Primary Liver Cancer
Liver Cancer
Drug: antineoplaston A10
Phase 2
Phase II
CLOSED
Age 14 and over
Protocol IDs
CDR0000066577
BC-HE-2, NCT00003530
http://cancer.gov/clinicaltrials/BC-HE-2
Antineoplaston Therapy in Treating Patients With Stage IV Pancreatic Cancer
Pancreatic Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Protocol IDs
Age 18 and over
CDR0000066578
BC-PA-2, NCT00003531
http://cancer.gov/clinicaltrials/BC-PA-2
Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Ovarian Cancer
Ovarian Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066579
BC-OV-2, NCT00003532
http://cancer.gov/clinicaltrials/BC-OV-2
Antineoplaston Therapy in Treating Patients With Metastatic Prostate Cancer
Prostate Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066580
BC-PR-4, NCT00003533
http://cancer.gov/clinicaltrials/BC-PR-4
Antineoplaston Therapy in Treating Patients With Refractory Stage IV Prostate Cancer
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066581
BC-PR-8, NCT00003534
http://cancer.gov/clinicaltrials/BC-PR-8
Antineoplaston Therapy in Treating Children With Recurrent or Refractory High-Grade Glioma
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 6 months to 17 years
Protocol IDs
CDR0000066582
BC-BT-6, NCT00003535
http://cancer.gov/clinicaltrials/BC-BT-6
· Protocol BT-06, involving the study of Antineoplastons A10 and AS2-1 in children with high grade glioma
BT-06 – Protocol #
19 – Patients Accrued
11 – Evaluable Patients
1 / 9.1 % – # and % of Patients Showing Complete Response
3 / 27.3% – # and % of Patients Showing Partial Response
3 / 27.3% – # and % of Patients Showing Stable Disease
4 / 36.4% – # and % of Patients Showing Progressive Disease
Methotrexate With or Without Antineoplaston Therapy in Treating Postmenopausal Women With Advanced Refractory Breast Cancer
Stage IV Breast Cancer
Recurrent Breast Cancer
Drug: antineoplaston A10
Drug: methotrexate
Procedure: alternative product therapy
Procedure: biological therapy
Procedure: biologically based therapies
Procedure: cancer prevention intervention
Procedure: chemotherapy
Procedure: complementary and alternative therapy
Procedure: differentiation therapy
Phase 2
NCT00003536
CDR0000066584, BC-BR-10
THIS STUDY HAS BEEN WITHDRAWN PRIOR TO ENROLLMENT
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 2
Phase II
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
A Randomized Study of Antineoplaston Therapy vs. Temozolomide in Subjects With Recurrent and / or Progressive Optic Pathway Glioma
Optic Nerve Glioma
Drug: Temozolomide
Drug: Antineoplaston A10 and Antineoplaston AS2-1 (ANP)
Phase 3
NOT YET RECRUITING
NCT01260103
BRI-BT-54
(· 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
2003
recurrent diffuse intrinsic brain stem glioma
Phase 2
phase II
antineoplaston A10 and AS2-1
6 months median duration of treatment
of all 12 patients
2 years / 33.3% – Survival
2 / 17% – alive and tumour free for over 5 years since initial diagnosis
from the start of treatment
5 years – 1 alive for more than
4 years – 1 alive for more than
Only mild and moderate toxicities were observed, which included
3 cases of skin allergy
2 cases of:
anaemia
fever
hypernatraemuia
single cases of:
agranulocytosis
hypoglycaemia
numbness
tiredness
myalgia
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
2004
incurable recurrent and progressive multicentric glioma
Phase 2
Phase II
antineoplaston A10 and AS2-1 (ANP)
9 – patients’ median age
6 patients were diagnosed with pilocytic astrocytoma
4 with low-grade astrocytoma
1 with astrocytoma grade 2
1 case of visual pathway glioma, a biopsy was not performed due to a dangerous location
16 months – The average duration of intravenous ANP therapy
19 months – The average duration of oral ANP
1 patient was non-evaluable due to only 4 weeks of ANP and lack of follow-up scans
1 patient who had stable disease discontinued ANP against medical advice and died 4.5 years later
10 patients are alive and well from 2 to >14 years post-diagnosis
Only 1 case of serious toxicity of reversible tinnitus, of 1 day’s duration, was described
2004
Protocol – incurable recurrent and progressive multicentric glioma
12 – Patients Accrued
– Evaluable Patients
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
http://www.secinfo.com/d11MXs.p23hz.htm
8/31/2012 (10/15/2012)
Form 10-Q (Received 10/15/12 • Period 08/31/12)
“The Company believes Antineoplastons are useful in the treatment of human cancer and is currently conducting PHASE II CLINICAL TRIALS of Antineoplastons relating to the treatment of cancer”
11/30/2012 (1/14/2013)
40–Active/Not Recruiting/Closed
Form 10-Q (For the quarterly period ended November 30, 2012) (1/14/2013)
“The Company is currently conducting ONE FDA-approved CLINICAL TRIAL”
http://www.faqs.org/sec-filings/130114/BURZYNSKI-RESEARCH-INSTITUTE-INC_10-Q
Clinical trial costs paid direct
2010 – $4,243,476
FDA clinical trial expenses paid directly by Burzynski
5/31/2010 – $1,230,650
2/28/2010 – $4,243,476
Clinical trial costs paid direct
2009 – $4,678,626
FDA clinical trial expenses paid directly by Burzynski
11/30/2009 – $3,040,367
8/31/2009 – $1,951,248
5/31/2009 – $934,293
2/28/2009 – $4,678,626
11/30/2008 – $3,605,450
8/31/2008 – $2,375,780
5/31/2008- $1,160,297
5/31/2007 – $964,090
5/31/2006 – $978,705
11/30/2005 – $3,070,881
11/30/2004 – $3,128,619
8/31/2002 – $1,741,950
5/31/2002 – $908,639
8/31/2001 – $2,320,149
5/31/2001 – $1,178,965
5/31/2000 – $902,027
5/31/1999 – $1,095,523
3/1/1996 – 2/28/1997 – $532,853 – increase
3/1/1996 – 2/28/1997 – 115.6% – increase mainly due to Company agreeing to pay 20% of cost of chemicals used in Phase II clinical trials conducted by Burzynski
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