Patient safety in the START trial was monitored frequently by an independent data monitoring committee and no new or unexpected safety concerns were noted for the study. In prior clinical studies, the most frequently reported adverse events included injection site reactions, flu-like symptoms, nausea, cough, fatigue, and dyspnea.
"These results from the START trial are disappointing, both for patients with NSCLC and for the many who have been involved in the L-BLP25 program," said Robert L. Kirkman, M.D., President and CEO of Oncothyreon. "L-BLP25 has been under development for more than a decade at Oncothyreon and its predecessor company, Biomira Inc. of Edmonton, Alberta, in collaboration with Merck KGaA. The contributions of many employees at each company, committed investigators and, particularly, the many patients who participated in multiple clinical trials over many years are gratefully acknowledged."
Conference Call and Webcast
Oncothyreon will conduct a conference call today, December 19, 2012 at 8:30 a.m. Eastern time ( 5:30 a.m. Pacific time) to discuss the outcome of the START trial and provide a review of its pipeline of products in development. To participate in the call by telephone, please dial (877) 280-7291 ( United States) or (707) 287-9361 (International). In addition, the call will be webcast live and can be accessed on the "Events" page of the "News & Events" section of Oncothyreon's website at www.oncothyreon.com. An archive of the webcast will be available after completion of the discussion and will be posted on Oncothyreon's website.About L-BLP25 L-BLP25 is an investigational MUC1 antigen-specific cancer immunotherapy that is designed to stimulate the body's immune system to identify and target cells expressing the cell surface glycoprotein MUC1. MUC1 is expressed in many cancers, such as non-small cell lung cancer (NSCLC), and has multiple roles in promoting tumor growth and survival. L-BLP25 was being investigated in the Phase III START trial and is currently being investigated in the INSPIRE trial, both for the treatment of unresectable stage III NSCLC.