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Biotech / Medical : Oncothyreon -- Ignore unavailable to you. Want to Upgrade?

To: Jibacoa who wrote (1581)	2/20/2001 5:49:41 PM
From: Ian@SI	Read Replies (1) \| Respond to of 2344

Biomira Presents at BIO'S CEO and Investor Conference NEW YORK, NY, Feb 20, 2001 /PRNewswire via COMTEX/ -- Biomira Inc. (NASD: BIOM) (TSE: BRA) today presented an update on the Company's lead product development programs to investors and industry representatives at the Biotechnology Industry Organizations' CEO & Investor Conference. "The year 2000 moved Biomira to the forefront of new cancer product development with the progression of our two late-stage investigational drugs," commented President and CEO Alex McPherson, MD, PhD, who spoke at the conference today. "Biomira's technology addresses two of the largest cancer markets - metastatic breast cancer and metastatic lung cancer- with innovative treatment approaches. THERATOPE(R) vaccine for metastatic breast cancer is nearing completion of enrolment of its Phase III trial and BLP25 for non-small cell lung cancer is moving forward in a Phase IIb study. These advances demonstrate Biomira's dedication to the management of cancer." At the conference, Dr. McPherson announced that Biomira has recruited 928 patients to date in its Phase III clinical trial with THERATOPE(R) vaccine. The Company plans to enroll 950 patients and keep the study open until the end of the first quarter to ensure it meets the 900 evaluable patients required for analysis and to ensure that patients currently being screened at sites have the opportunity to participate in the trial. Dr. McPherson also explained that the THERATOPE(R) trial is foremost a survival study. The trial was designed to include interim analyses on time-to- disease progression and survival in order to maximize the possibility of success at the earliest possible time. Biomira has planned two interim analyses for the THERATOPE(R) vaccine trial to make this product candidate available to cancer patients as soon as possible, should the preliminary data demonstrate therapeutic benefit before the final analysis. The first of these analyses is anticipated to be initiated in the third quarter of 2001. The precise timing of the first interim analysis, as well as the second and the final analysis, are dependent upon a statistical model that requires a pre-determined number of events in each of the two primary endpoints (disease progression and survival). An independent Data Safety Monitoring Board (DSMB) conducted two data and safety review of the THERATOPE(R) vaccine trial in 2000, and confirmed that the Phase III study was on track and should progress without modification. The DSMB is planning a third review of the data from the trial's first 800 patients by end of the second quarter 2001. The US Food and Drug Administration (FDA) has designated THERATOPE(R) vaccine as a Fast Track Drug Development program. The FDA's fast track programs are designed to expedite the review of drugs for serious or life-threatening conditions that address unmet medical needs. Also today, Dr. McPherson described the advancement of the BLP25 vaccine program. Biomira is currently testing BLP25 vaccine in a clinical trial of 166 patients with metastatic non-small cell lung cancer to establish the drug's safety profile and determine whether an immune response against the vaccine translates into clinical survival benefit. The randomized and controlled Phase IIb study is currently being conducted in Canada. Enrolment of the trial has occurred slower than expected. The Company has undertaken additional measures to address this, much like what was done for the THERATOPE(R) vaccine trial. More centres will be opening, expanding into the United Kingdom, and the Company will be making other efforts to promote the availability and increase awareness of this trial. Enrolment will continue into next year. In August 1999, Biomira commenced a Phase II trial with BLP25 vaccine to establish dosing and frequency. Final analysis confirmed the demonstrated strong T-cell response in 6 of 8 evaluable patients. To date, half of the patients remain alive. However, in small numbers such as this, survival tracking is only interesting. A parallel Phase II BLP25 trial was designed to determine whether the addition of the immune enhancer interleukin-2 (IL-2), encapsulated in a liposome, could enhance the vaccine's immunological response, while preserving a reasonable safety profile. That trial has completed enrolment of 18 patients and data are being analyzed. Biomira is currently negotiating a corporate alliance for its lead vaccine programs. A collaborator would be able to move forward with Biomira to maximize the commercial potential of both product candidates, alone and in conjunction with other immunotherapies. The Biotechnology Industry Organization is a Washington, D.C.-based organization that engages in lobbying, advocacy, communications and new business development related to the biotech industry. Established in 1993, today it includes more than 940 companies, academic institutions and state biotech centers in all 50 U.S. states and 33 other nations. The goal of the CEO and Investor Conference is to provide a unique and neutral forum where CEOs from small, medium and large cap public companies and private firms planning to go public can interact with investors and other members of the financial community and the healthcare industry. 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).