Post #52 con't
During today's presentation, Dr. McPherson also described plans Biomira is aggressively pursuing for additional clinical trials with BLP25 vaccine. A Phase I study with BLP25 vaccine provided safety, immunological and survival data on 17 highly selected stage IIIb and stage IV non-small cell lung cancer patients randomized to be treated with either 20 mg or 200 mg doses of the vaccine. Preliminary immunology data demonstrated the induction of a cytotoxic T-lymphocyte (CTL) response capable of killing tumor cells in five out of the 12 evaluable non-small cell lung cancer patients from both arms of the study. BLP25 vaccine was found to be well tolerated and relatively non-toxic.
The median survival time of patients treated with the 20 mg dose regimen was 5.4 months from the time of entry to the study. The Kaplan-Meier projection of the median survival of the 200 mg dose regimen group is 14.7 months from the time of entry to the study, with three of the eight patients (37.5%) still alive.
Biomira is now conducting a series of Phase II trials to optimize the immune response against the BLP25 vaccine. The first stage of the Phase II trial was a study utilizing a dosage of 1000 mg of BLP25, which has been shown to induce a very strong CTL immune response in six out of eight patients to date. To the Company's knowledge, this type of T-cell mediated cellular immune response has never been previously achieved in human carcinoma patients, nor was this level observed in the 20 mg or 200 mg patients in Phase I. Patients are being followed to determine if this increased T-cell response is reflected in an increased survival benefit. This type of immune response is strongly associated with tumour rejection in many pre-clinical animal models. Biomira is expecting to have survival data in the final quarter of 2000.
The Company is currently enrolling non-small cell lung cancer patients in a second stage of the Phase II trial to determine whether the vaccine's immunogenicity can be further enhanced when combined with Liposomal Interleukin-2.
In a third research and development initiative, Biomira Inc. and its co-developer, Biovector Therapeutics of Toulouse France, are conducting an NCI-sponsored Phase I trial with an idiotypic vaccine for B-cell lymphoma. This novel treatment uses vaccines that incorporate each patient's cancer antigen into a Liposomal Interleukin-2 formulation, and is specific for each individual patient. The vaccine is intended to trigger an immune attack directed specifically to the lymphoma cells. Early clinical data indicate that the autologous lymphoma vaccine is well tolerated and induces a potent anti-lymphoma immune response.
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 850 member companies. 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. |
