NEW YORK, Feb. 16 /CNW-PRN/ - Biomira Inc. (NASDAQ: BIOM) (TSE: BRA) today presented at the Biotechnology Industry Organizations' second annual CEO & Investor Conference, highlighting the Company's clinical and financing developments.
We now have three major cancer vaccine product candidates plus an immune enhancer, Liposomal IL-2, in the clinic and up to U.S. $100 million in financing potentially available to push our products through to commercialization,' commented President and CEO Alex McPherson, MD, PhD, who spoke at the conference today. ``Biomira is addressing the largest cancer markets with innovative product candidates. THERATOPE(R) vaccine for metastatic breast cancer is now in a pivotal Phase III trial, and BLP25 for lung cancer is in Phase II testing. Our patient-specific vaccine for lymphoma, co-developed with Biovector Therapeutics of Toulouse, France and the National Cancer Institute (NCI), entered NCI-sponsored Phase I trials in the first half of last year. We have a talented scientific staff and a strategically minded and dedicated management team that should be credited with our progress and success.'
At the conference, the Company reviewed its recently announced equity line financing and the increase in the maximum dollar amount of such financing from U.S. $36 million to a maximum of U.S. $100 million. The term of the equity line has also been increased from 30 months to 42 months. No additional shares of Biomira stock were needed to be reserved for issue, due to the increase in valuation and liquidity of the Company's common stock. As Biomira continues negotiations with potential partners, the equity line gives the Company the ultimate flexibility of taking only the cash needed to develop its product portfolio.
Dr. McPherson also announced that the Company expects to complete enrolment of its Phase III THERATOPE(R) vaccine trial in the second half of 2000. The THERATOPE(R) vaccine Phase III trial will confirm whether the vaccine, Biomira's lead product candidate, is effective in increasing patient survival as suggested by data from several Phase II trials. This trial is intended to include 900 evaluable patients with metastatic breast cancer. Enrolment has been increasing steadily in recent months, with more than 370 patients currently participating.
The multinational study officially began enrolling patients in late 1998 with most of the approximately 75 original sites in the U.S., the U.K., France, Germany, Belgium, Spain and Canada accruing patients in 1999. Biomira is in the process of adding approximately 30 new clinical sites to the trial, including sites in Australia, New Zealand and Ireland, plus additional sites in the U.S. and Europe. It is anticipated that there will shortly be more than 100 sites worldwide enrolling patients.
In the original 75 active sites, the trial accrued an average of 41 new patients per month over the last two months as the ramp-up continued. The current recruitment pace is expected to increase with the addition of the new study locations. In addition, in order to make the trial accessible to as many women as possible, the Company made amendments to its clinical trial protocol, allowing patients on hormonal therapy to participate and extending the window of opportunity during which patients may enroll. As well, the Company is attempting to ensure that patients on emerging first line chemotherapy treatments can be incorporated into the trial.
The Company is also aggressively pursuing public relations efforts and working with advocacy groups to make patients and their physicians aware of the opportunity to be involved in a clinical trial with this investigational product candidate. Investigators and patients have responded favorably to our efforts, and the Company feels confident that the trial accrual rate will increase even further with |
