Biomira - Encouraging Phase I BLP25 Vaccine Survival Data in Non-Small Cell Lung Cancer Patients at Keystone Symposium
Wednesday January 26, 7:59 am Eastern Time
EDMONTON, Alberta, Jan. 26 /PRNewswire/ -- Biomira Inc. (Nasdaq: BIOM - news; Toronto: BRA. - news) announced it presented data at a Keystone Symposia entitled ``Cellular Immunity and Immunotherapy of Cancer,' in Santa Fe, New Mexico. The presentation given yesterday included data from its Phase I and Phase II BLP25 vaccine trials, indicating strong MUC1 specific T-cell proliferation in patients with non-small cell lung cancer. Encouraging survival observations were also reported from the Phase I clinical trial.
The Phase I BLP25 vaccine trial, in which enrollment was completed in March 1999, gathered safety, immunological and survival data on 17 highly selected 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 able to kill tumor cells, in five out of the 12 evaluable non-small cell lung cancer patients from both arms of the study. 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 (36.5%) still alive. BLP25 vaccine was found to be well tolerated and is relatively non-toxic.
``We are moving aggressively with this vaccine program and are sufficiently encouraged by these early results that we are considering developing a proposal for a pivotal, randomized and comparative Phase IIb study. The purpose of this trial would be to determine the survival advantage of the vaccine in addition to standard treatment compared to standard treatment alone for patients with metastatic non-small cell lung cancer. With three patients still alive in our Phase I study, the final median survival of the 200 mg dose regimen group after the data is fully mature, could range from 11.5 to 14.7 months. This data is only calculated from the time the patients entered the clinical trial and not from their earlier time of diagnosis. This is despite the fact that we suspect that the 200 mg dose is still below the optimal dose,' said Alex McPherson, MD, PhD, President and CEO of Biomira. Biomira is currently conducting a Phase II clinical trial program to determine how to optimize the immune response against the vaccine in patients with non-small cell lung cancer. The Phase II program examined the effect of a higher dose (1000 mg) of the BLP25 vaccine. Enrollment for this stage was completed in December 1999. The higher dose has induced a strong MUC1 specific T-cell proliferation response in five out of seven evaluable patients. This observation is very encouraging in view of the important role of TH1 responses in controlling cancer.
Yesterday, Biomira also announced the initiation of the second stage of its Phase II clinical trial program with BLP25 vaccine to determine if the effect of the vaccine is enhanced by the addition of Liposomal IL-2, while maintaining a satisfactory safety profile.
BLP25 vaccine incorporates a synthetic 25-amino acid sequence of the MUC-1 cancer mucin, encapsulated in a synthetic liposomal delivery system. The liposome facilitates better delivery to the immune system and enhances recognition of the cancer antigen by the immune system. BLP25 vaccine is an investigational therapeutic vaccine designed to induce an immune response to cancer cells.
Biomira is a biotechnology company specializing in the development of innovative therapeutic approaches to cancer management. The company is currently enrolling up to 900 evaluable patients in a multinational Phase III trial with THERATOPE© vaccine, as well as developing a portfolio of complimentary vaccine candidates, including BLP25 vaccine for non-small cell lung cancer, now in phase II trials. 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). |
