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First Non-Small Cell Lung Cancer Patient Enrolled in Phase 3 Liposome Vaccine Trial
"Enrolling the first patient in this Phase III trial is a major step forward for Biomira's therapeutic vaccine technology and represents an important milestone toward our goal of commercializing important new cancer therapies," said Robert L. Kirkman, M.D., President and Chief Executive Officer of Biomira. "To our knowledge, this is the first Phase III trial of a therapeutic vaccine in unresectable stage III NSCLC, which, if successful, would offer new hope for patients with limited options."
Dr. Kirkman added, "In 2007 we expect to make additional progress in advancing our clinical pipeline. The Phase II trial of PX-12 in patients with advanced pancreatic cancer is ongoing and we expect to bring PX-478 into clinical development at mid-year. With this progress, we are building a diverse clinical portfolio of innovative potential cancer therapies, and moving closer to realizing the value of our vaccine and small-molecule platforms."
According to the American Cancer Society, lung cancer is the leading cause of cancer-related deaths in both men and women worldwide with approximately 80 percent of lung cancer cases classified as NSCLC. Further, only about 15 percent of people diagnosed with NSCLC survive this disease after five years. For most patients with NSCLC, current treatments provide limited success.
Enrollment in the START trial, which is expected to include more than 1,300 patients in approximately 30 countries, is now open to patients in the U.S. where the first randomization has occurred. It is expected that enrollment will subsequently expand to additional countries. Currently, there are no approved maintenance therapies for patients responding to first-line treatment for unresectable stage III NSCLC.
About the START Trial
The START trial is a randomized, double-blind, placebo-controlled study that will evaluate patients with documented unresectable stage III NSCLC who have had a response or stable disease after at least two cycles of platinum based chemo-radiotherapy. The study has been designed considering scientific advice from the European Medicines Agency (EMEA/CHMP) and has been agreed upon with the U.S. Food and Drug Administration (FDA) through a Special Protocol Assessment (SPA). Data from a randomized Phase IIb trial described below encouraged the initiation of the Phase III program.
Stimuvax is an innovative cancer vaccine designed to induce an immune response to cancer cells that express MUC1, a protein antigen widely expressed on common cancers. MUC1 is over expressed on many cancers such as lung cancer, breast cancer and colorectal cancer. Stimuvax is thought to work by stimulating the body's immune system to identify and destroy cancer cells expressing MUC1.
A randomized Phase IIb trial was conducted in 171 patients with stage IIIb and IV NSCLC with response or stable disease after first line therapy. While the overall study results were not statistically significant, in the randomization stratum of patients with stage IIIb locoregional disease, Stimuvax showed a median survival of 30.6 months versus 13.3 months in the control group - an improvement of 17.3 months. In the Phase IIb trial, side effects were primarily limited to mild-to-moderate flu-like symptoms, GI disturbances, and mild injection site reactions.