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Biotech / Medical : BIOMIRA RESEARCH (BIOM)

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To: chirodoc who wrote (66)	5/8/2000 12:14:00 PM
From: chirodoc	Read Replies (1) of 72

FDA grants fast track status for THERATOPE(R) vaccine EDMONTON, May 8 /CNW-PRN/ - Biomira Inc. (Nasdaq: BIOM) (TSE: BRA) today announced the US Food & Drug Administration has designated the investigation of THERATOPE(R) vaccine for metastatic breast cancer as a Fast Track Drug development program. The FDA's fast track programs are designed to facilitate the development and expedite review of drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. ``We have reviewed your request and concluded that it meets the criteria for the Fast Track designation,'' states a recent letter from the FDA to Biomira. ``Therefore, we are designating as a Fast Track Drug Product development program the investigation of THERATOPE(R) vaccine as an adjunct to the first line combination chemotherapy in responding patients with metastatic breast cancer for its effect on the prolongation of the time-to-disease progression and increase in overall survival.'' Earlier studies to date have suggested THERATOPE(R) vaccine offers significant survival benefits to patients with metastatic breast cancer over today's standard treatments alone. In one arm of two parallel prospectively randomized trials, THERATOPE(R) vaccine-treated patients had a median survival of 26.5 months compared to 9.2 months in a retrospective control group. Biomira is currently evaluating THERATOPE(R) vaccine in a pivotal Phase III trial with 900 evaluable patients. The Company expects to complete enrolment by year's end 2000. ``This is a significant milestone for the Company, highlighting the importance of new drugs such as THERATOPE(R) vaccine to one day address a sizeable unmet need in this patient population,'' commented Alex McPherson, MD, PhD, President & CEO of Biomira. ``We believe our vaccine will be able to provide a new treatment option for women with breast cancer that has the potential to both extend and improve the quality of their lives.'' Biomira is a biotechnology company specializing in the development of innovative therapeutic approaches to cancer management. The commitment to the treatment of cancer currently focuses on the development of synthetic vaccines and novel strategies for cancer immunotherapy. We are The Cancer Vaccine People(TM).

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