Burzynski Research Institute Receives Orphan Drug Designation for Antineoplastons

[Guest guest]

I am surprised. The US government (FDA) has been

trying to put him out of business for about 20 years

now. He has been curing brain cancer in children for

some time now with his nontoxic amino peptides. He

and his patients have been arrested and harrassed in

the past. They lately made all kind of rules against

him to restrict him to only patients who had had the

full course of conventional chemo first and it had failed

so the patents were almost dead by the time he

got them, etc.

The last that I heard was that antineoplastins were to

be made in Poland. F.

 

 

http://biz./bw/040907/76097_1.html

 

Press Release Source: Burzynski Research Institute

 

Burzynski Research Institute Receives Orphan Drug

Designation for Antineoplastons A10 and AS2-1 for

Treatment of Brain Stem Glioma

Tuesday September 7, 7:13 pm ET

 

HOUSTON--(BUSINESS WIRE)--Sept. 7, 2004--Burzynski

Research Institute (BRI) (OTCBB:BZYR - News) announced

today that the U.S. Food and Drug Administration (FDA)

has granted orphan drug designation for its drug

candidates Antineoplastons A10 and AS2-1 for the

treatment of brain stem glioma.

 

The FDA's orphan drug program is intended to encourage

research, development and approval of products for

diseases that affect fewer than 200,000 patients in

the United States per year and provide a significant

therapeutic advantage over existing treatments. If

Antineoplastons A10 and AS2-1 receive approval from

the FDA, orphan drug designation will provide

Antineoplastons A10 and AS2-1 with seven years of

market exclusivity following such regulatory approval.

The designation also enables BRI to apply for clinical

research funding, tax credits on clinical research and

development expenses, a potential waiver of user fees

associated with filing the marketing application and

assistance from the Office of Orphan Product

Development (OOPD) in guiding the drug through the

regulatory approval process.

 

" We are pleased to receive the FDA's orphan drug

designation for Antineoplastons A10 and AS2-1, an

important step toward bringing this treatment to

market, " said Luke E. Lawson, Ph.D., Director of

Regulatory Affairs of BRI. " Therapeutic options for

brain stem glioma patients are rather limited. We are

committed to accelerating, wherever possible, our

efforts to help address the unmet medical need of

these patients worldwide. "

 

Burzynski Research Institute is a biopharmaceutical

company committed to developing medicines for serious

and life threatening diseases from genomics and

naturally occurring compounds. Research and

development efforts are focused on antineoplastons,

autoimmune disease and HIV.

 

Forward-looking statements in this release are made

pursuant to the safe harbor provisions of the federal

securities laws. BRI cautions investors not to place

undue reliance on the forward-looking statements

contained in this press release. Information contained

in forward-looking statements is based on current

expectations and is subject to change, and future

events may differ materially from those discussed

herein due to a number of factors, including, but not

limited to, risks and uncertainties related to BRI's

ability to obtain regulatory approval for

Antineoplastons A10 and AS2-1. Receiving orphan drug

designation does not increase the likelihood of

eventual regulatory approval for a product candidate.

BRI does not undertake to update any such

forward-looking statements or to publicly announce

developments or events relating to the matters

described herein.

Contact:

 

Burzynski Research Institute, Houston

Mike Goldberg, 713-335-5609

info

www.burzynskiresearch.com