THERATOPE(R) gets go ahead from data safety monitoring board
Biomira CEO Updates Shareholders At Annual Meeting
EDMONTON, May 17 /CNW-PRN/ - Biomira Inc. (Nasdaq: BIOM) (TSE: BRA) will announce at its Annual Shareholder's Meeting today that the US Data Safety Monitoring Board (DSMB), after reviewing data from the first 300 patients who have completed at least the first 12 weeks of therapy, recommended the Company continue advancing its Phase III trial with THERATOPE(R) vaccine for metastatic breast cancer as planned. This comes on the heels of an announcement in which the US Food & Drug Administration designated THERATOPE(R) vaccine as a Fast Track Drug development program.
``Having reviewed the safety data, the DSMB feels the trial should continue without any modifications,'' members of the DSMB unanimously stated.
At its Annual Meeting, Biomira's President and CEO Alex McPherson, MD, PhD, will discuss significant developments of the last year, including the Company's recent financing of up to US $100 million and continued progress in its drug development programs, and will highlight major milestones expected for the year 2000.
``This is a very positive and encouraging statement by the DSMB and a major milestone for Biomira as we continue enrolling patients in our pivotal trial with THERATOPE(R) vaccine for this important cancer indication,'' Dr. McPherson commented. ``It indicates the trial is showing the same excellent safety data shown in the Phase II trial, and we are confident as we move towards a potential regulatory approval for this product. We are well on track and expect to complete enrollment in the study by year's end, while planning to initiate a Phase IIb trial with BLP25 vaccine for non-small cell lung cancer, which could lead to a potential regulatory approval.''
The Phase III THERATOPE(R) vaccine study is now ongoing at over 115 clinical sites in North America, Europe, Australia and New Zealand and is steadily accruing patients. As of May 12th, 480 patients were enrolled, with ramp up growing in the last several months since Biomira initiated an aggressive clinical enrollment campaign and expanded the total number of clinical sites.
In February 2000, Biomira's equity line of financing was increased to US $100 million, putting the Company in a strong financial position to advance its product candidates. The Company has drawn down net proceeds of Canadian $46.1 million (US. $31.8 million) to April 24, 2000, with a resulting cash infusion that has more than doubled the Company's financial reserves to approximately $67.0 million (US $46.2 million) to April 30, 2000.
This new financing places the Company in a favorable negotiating position, and among Biomira' s expected milestone events in 2000 is the announcement of a collaboration for one or both of its lead product candidates. Besides completing enrollment in its Phase III THERATOPE(R) vaccine trial in 2000, the Company also expects to announce survival results from the first of two Phase II studies with BLP25 vaccine.
Among Biomira's accomplishments in 1999/2000 was the advancement of BLP25 vaccine into Phase II trials with non-small cell lung cancer patients. Preliminary results of one of these studies suggest that a higher dose and more frequent administration of the vaccine is capable of producing a cellular immune response against cancer cells that, to the Company's knowledge, has never previously been achieved in cancer patients. Biomira is also enrolling a second Phase II trial to determine if adding the immune enhancer Liposomal Interleukin-2 to the BLP25 vaccine formulation enhances the drug's effect while maintaining a satisfactory safety profile.
Biomira's liposomal idiotypic vaccines, developed in collaboration with Biovector Therapeutics of Toulouse, France, entered Phase I clinical trials at the National Cancer Institute in 1999. These patient-specific vaccines are being tested in patients with non-Hodgkin's B-cell lymphoma. Preliminary data suggest the vaccine is well tolerated and capable of producing a powerful immune response against cancer cells.
Biomira investigators will be presenting data at the 36th Annual Meeting of the American Society of Clinical Oncology (ASCO), May 19-23, on new research in dendritic cell therapy, the body's most potent antigen presenting cells, combined with BLP25 vaccine in a Phase I trial. Also at ASCO, final survival data from a Phase I trial of BLP25 will be presented for the first time. Other new Company initiatives include research in the use of the MUC1 cancer mucin, the basis for Biomira's vaccines, in the treatment of autoimmune diseases.
``We have had an exciting year, both in terms of our existing drug programs and new development initiatives, and have achieved significant momentum towards achieving our goals,'' Dr. McPherson said. ``We have a well diversified pipeline and potential products at every stage of clinical development, plus the cash reserves and partnering prospects to move forward with confidence. I believe the next 12 months and beyond hold tremendous promise for Biomira, its shareholders and the cancer patients who stand to benefit from our innovations.''
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