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Biotech / Medical : BIOMIRA RESEARCH (BIOM)

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To: chirodoc who wrote (67)5/9/2000 10:51:00 AM
From: chirodoc  Read Replies (1) of 72
 
WALL STREET JOURNAL ARTICLE

Biomira Gets Fast Track Status On Breast Cancer Vaccine
Dow Jones Newswires

EDMONTON -- The Food and Drug Administration granted fast track status on Biomira Inc.'s (BIOM) Theratope metastatic breast cancer vaccine.

In a press release Monday, Biomira said Theratope was designated for the fast track program in studies as an adjunct to first line combination chemotherapy.

The biotechnology company said earlier studies suggest Theratope offers "significant" survival benefits compared with standard treatments alone.

Fast track programs are designed to facilitate the development and expedite review of drugs that treat unmet serious or life-threatening conditions.

In one arm of two parallel prospectively randomized trials, vaccine-treated patients had a median survival of 26.5 months compared with 9.2 months in a retrospective control group.

Biomira, which is evaluating the treatment in a Phase III trial with 900 evaluable patients, expects to complete enrollment by the end of the year.

-Eamon Beltran; Dow Jones Newswires; 201-938-
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