Burzynski Securities and Exchange Commission (SEC) Links

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11/25/1997 – FORM 10-SB

Click to access 0000950110-97-001598.pdf

12/10/1997
http://www.siliconinvestor.com/readmsg.aspx?msgid=2965068
Burzynski developed
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6 formulations of natural Antineoplastons
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6 synthetic formulations of Antineoplastons
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All Phase II clinical trials currently involve use of
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4 formulations of synthetic Antineoplastons known as
A10 and AS2-1 in capsules and injections
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Company currently conducting laboratory research involving
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new generation of Antineoplastons A10 and AS2-1
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In addition to original family of Antineoplaston compounds

(the “Parental Generation”)

Company continues development of
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2nd generation of Antineoplastons
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In cell culture experiments
2nd generation Antineoplastons developed by Company, have been shown to be at least
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a thousand times more potent then
Parental Generation
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Company developing
3rd generation structurally altered Antineoplaston Company believes will exhibit markedly improved anticancer activity in human cancer cell lines resistant to
Parental Generation
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10/1997 only 2 clinical trials reached Milestone
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Clinical Trial BT-11
Clinical Trial BT-18
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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
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Another trial of Clinical Trial BT-11 involves patients with brain stem glioma
trial approved by FDA 5/1996
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Clinical trials conducted by Burzynski 3/1/1996 – 2/28/1997
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11/25/1997 72 Phase II clinical trials conducted pursuant to INDs filed with FDA
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12/10/1997
http://www.siliconinvestor.com/readmsg.aspx?msgid=2965068
72 Phase II Clinical Trials
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10/30/1998 (11/12/1998)
http://www.sec.gov/Archives/edgar/data/724445/0001015402-98-000442.txt
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5/31/2000 (5/10/2001) 10QSB
http://www.sec.gov/Archives/edgar/data/724445/0000912057-01-514477.txt
72 FDA approved clinical trials
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5/31/2001 (7/12/2001) 10QSB
http://www.sec.gov/Archives/edgar/data/724445/0000912057-01-523630.txt
72 FDA approved clinical trials
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5/31/2002 (7/10/2002) FORM 10-QSB
http://www.sec.gov/Archives/edgar/data/724445/0000912057-02-027187.txt
72 FDA approved clinical trials
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8/31/2002
http://www.sec.gov/Archives/edgar/data/724445/000091205702038660/a2091272z10qsb.txt
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11/30/2002 (1/14/2003)

Click to access 0001047469-03-001370.pdf

72 FDA approved clinical trials
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5/31/2003
http://google.brand.edgar-online.com/EFX_dll/EDGARpro.dll?FetchFilingHtmlSection1?SectionID=2384291-21562-30830&SessionID=yDBMFSPZzEQ6eD7
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10/15/2003-7/15/2008
http://marketbrief.com/bzyr/10qsb
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11/10/2004
http://www.sec.gov/Archives/edgar/data/724445/000104746904033767/0001047469-04-033767.txt
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10/15/2003-7/15/2008
http://marketbrief.com/bzyr/10qsb
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11/30/2005 – For the quarterly period ended
http://edgar.secdatabase.com/1472/95012906000296/filing-main.htm
35 FDA-approved clinical trials
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11/30/2005
http://google.brand.edgar-online.com/EFX_dll/EDGARpro.dll?FetchFilingHtmlSection1?SectionID=4132756-45428-48732&SessionID=sghhFSHpJO17En2
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5/31/2007
http://edgar.secdatabase.com/1173/110465907054073/filing-main.htm
27 FDA-approved clinical trials
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10/15/2003-7/15/2008
http://marketbrief.com/bzyr/10qsb
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1/13/2009 (1/4/2011)
http://www.mystockbuddy.com/forum/archive/index.php/t-3959.html
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1/13/2009
http://www.sec.gov/Archives/edgar/data/724445/000110465909002283/a09-2965_1ex99d1.htm
1/13/2009 Burzynski Research Institute Gets SPA Clearance from 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. (BRI) announced it has reached agreement with U.S. Food and Drug Administration (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 & amino acid derivatives found in human body to target & control cancer cells without destroying normal cells

Agreement made under FDA’s Special Protocol Assessment (SPA) procedure & means design & planned analysis of Phase III study is acceptable to support 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 & challenged further by severely limited treatment options & clinical trials that could expand & discover new, efficacious therapies,” said Stanislaw R. Burzynski, M.D., Ph.D

“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 this important milestone independently without financial backing from the government, & without a major pharmaceutical partner—a unique accomplishment in the oncology field

From inception, we have been committed to developing a targeted gene therapy option that is less aggressive on the body than conventional therapies & have made considerable progress on the steps mandated by the FDA to bring a new drug to a patient community & 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

Combines highly malignant characteristics with very difficult location of brainstem

DBSG are inoperable because they involve most of brainstem (diffuse & intrinsic)

# of children in U.S. with brainstem gliomas is approximately 660

Absent treatment, survival rate from time of diagnosis is 6 months or less

At present, no standard curative treatments for disease

RT is only treatment that may slow its progress, but at 2 years 93% of children with this type of cancer die, & none of them survive for 5 years

Other conventional treatments such as chemotherapy have generally been tried in clinical trials but shown to be ineffective

There are no pharmacological treatments approved for DBSG at this time

Burzynski Research Institute, Inc. (OTCBB: BZYR) is biopharmaceutical company committed to developing treatment for cancer based on genomic & epigenomic principles

19 Phase II clinical trials
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5/21/2009
http://co-codes.com/index.php?cik=0000724445
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5/29/2009
http://www.wikinvest.com/stock/Burzynski_Research_Institute_(BZYR)/Introduction
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Currently conducted phase II
http://www.wikinvest.com/stock/Burzynski_Research_Institute_(BZYR)/Liquidity_Capital_Resources
2009, Phase II FDA-supervised clinical trials of Antineoplastons successfully came to a close
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5/29/2009
http://www.wikinvest.com/stock/Burzynski_Research_Institute_(BZYR)/Liquidity_Capital_Resources
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5/31/2009 (7/15/2009) Form 10-Q
http://www.sec.gov/Archives/edgar/data/0000724445/000110465909043323/0001104659-09-043323-index.htm
12/2/2008 Company announced orphan drug designation of Antineoplastons A10 and AS2-1 was expanded to treatment of all gliomas
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5/31/2009 (7/15/2009) 10-Q
http://edgar.secdatabase.com/2086/110465909043323/filing-main.htm
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5/31/2009 (7/15/2009) 10-Q PDF:

Click to access 0001104659-09-043323.pdf

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5/31/2009
http://www.sec.gov/Archives/edgar/data/0000724445/000110465909043323/0001104659-09-043323-index.htm
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8/31/2009 (10/15/2009) 10-Q
http://edgar.secdatabase.com/2782/110465909059014/filing-main.htm
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8/31/2009 (10/15/2009) 10-Q PDF:

Click to access 0001104659-09-059014.pdf

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8/31/2009
http://www.sec.gov/Archives/edgar/data/0000724445/000110465909059014/0001104659-09-059014-index.htm
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11/30/2009 (1/14/2010) Form 10-Q

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
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11/30/2009 (1/14/2010) 10-Q
http://edgar.secdatabase.com/741/110465910001658/filing-main.htm
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11/30/2009
http://www.sec.gov/Archives/edgar/data/0000724445/000110465910001658/0001104659-10-001658-index.htm
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11/30/2009 (1/14/2010) 10-Q PDF:

Click to access 0001104659-10-001658.pdf

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2/28/2010 Form 10-K (6/1/2010)
http://www.sec.gov/Archives/edgar/data/0000724445/000110465910031825/0001104659-10-031825-index.htm
Orphan Drug Designation

9/7/2004 FDA granted “orphan drug” status to Company’s Antineoplastons under Orphan Drug Act of 1983

Company began Phase II clinical studies in 1994 with 4 studies

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
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2/28/2010
http://www.stocks-news.info/search/BZYR
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2/28/2010 (5/31/2010) 10-K
http://edgar.secdatabase.com/918/110465910031825/filing-main.htm
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2/28/2010
http://www.sec.gov/Archives/edgar/data/0000724445/000110465910031825/0001104659-10-031825-index.htm
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2/28/2010 (6/1/2010)10-K

Click to access 0001104659-10-031825.pdf

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5/31/2010 Form 10-Q (7/15/2010)
http://www.sec.gov/Archives/edgar/data/0000724445/000110465910038168/0001104659-10-038168-index.htm
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

http://www.sec.gov/Archives/edgar/data/0000724445/000110465910038168/0001104659-10-038168-index.htm
2/1/2010 Company entered into agreement with Cycle Solutions, Inc., dba ResearchPoint

5 FDA-approved clinical trials
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5/31/2010 (7/15/2010) 10-Q
http://edgar.secdatabase.com/1263/110465910038168/filing-main.htm
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5/31/2010
http://www.sec.gov/Archives/edgar/data/0000724445/000110465910038168/0001104659-10-038168-index.htm
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5/31/2010 (7/15/2010) 10-Q PDF:

Click to access 0001104659-10-038168.pdf

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8/31/2009 (10/15/2009) Form 10-Q
http://www.sec.gov/Archives/edgar/data/0000724445/000110465909059014/0001104659-09-059014-index.htm
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8/31/2010 (10/15/2010) 10-Q
http://edgar.secdatabase.com/541/110465910052441/filing-main.htm
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8/31/2010
http://www.sec.gov/Archives/edgar/data/0000724445/000110465910052441/0001104659-10-052441-index.htm
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8/31/2010 (10/15/2010) 10-Q PDF:

Click to access 0001104659-10-052441.pdf

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11/30/2010 (1/14/2012)
http://edgar.secdatabase.com/1977/110465911001561/filing-main.htm
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11/30/2010 (1/14/2011) 10-Q

Click to access 0001104659-11-001561.pdf

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1/4/2011 (1/13/2009)
http://www.mystockbuddy.com/forum/archive/index.php/t-3959.html
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2/28/2011 (5/31/2011) 10-K
http://edgar.secdatabase.com/2683/110465911032257/filing-main.htm
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2/28/2011 (5/31/2011) 10-K
http://www.sec.gov/Archives/edgar/data/0000724445/000110465911032257/0001104659-11-032257-index.htm
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2/28/2011 (5/31/2011) 10-K PDF:

Click to access 0001104659-11-032257.pdf

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5/31/2011 (7/15/2011) 10-Q

Click to access 0001104659-11-039275.pdf

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5/31/2011 10-Q
http://edgar.secdatabase.com/704/110465911039275/filing-main.htm
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5/31/2011 (7/15/2011) 10-Q
http://www.sec.gov/Archives/edgar/data/0000724445/000110465911039275/00011046/59-11-039275-index.htm
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8/31/2011 (10/17/2011) 10-Q PDF:

Click to access 0001104659-11-056283.pdf

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8/31/2011 (10/17/2011) 10-Q
http://edgar.secdatabase.com/2717/110465911056283/filing-main.htm
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8/31/2011 (10/17/2011) 10-Q
http://www.sec.gov/Archives/edgar/data/0000724445/000110465911056283/0001104659-11-056283-index.htm
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9/8/2011 (9/12/2011) 8-K
http://edgar.secdatabase.com/682/110465911051249/filing-main.htm
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9/8/2011
http://www.sec.gov/Archives/edgar/data/0000724445/000110465911051249/0001104659-11-051249-index.htm
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9/8/2011 (9/12/2011) 8-K PDF:

Click to access 0001104659-11-051249.pdf

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10/18/2011
http://www.highbeam.com/doc/1P3-2487745501.html
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11/30/2011 (1/17/2012) 10-Q PDF:

Click to access 0001104659-12-014985.pdf

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11/30/2011 (1/17/2012) 10-Q
http://edgar.secdatabase.com/1093/110465912002343/filing-main.htm
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11/30/2011
http://www.sec.gov/Archives/edgar/data/0000724445/000110465912002343/0001104659-12-002343-index.htm
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11/30/2011
http://www.sec.gov/Archives/edgar/data/0000724445/000110465911001561/0001104659-11-001561-index.htm
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1/14/2012 10-Q
http://www.burzynskiresearch.com/sec-fillings.html
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2/29/2012 Form 10-Q
(as of May 1, 2012) Protocol BT
http://www.sec.gov/Archives/edgar/data/724445/000110465912040430/a12-12972_110k.htm
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2/29/2012 (5/29/2012) 10-K PDF

Click to access 0001104659-12-040430.pdf