SEATTLE, Oct. 7 /PRNewswire-FirstCall/ - Oncothyreon Inc. (Nasdaq: ONTY) today announced the publication of two-year safety and survival data from a Phase 1/2 clinical trial of Stimuvax(R) (BLP25 liposomal vaccine) in patients with non-small cell lung cancer. The article "A Multicenter Open-Label Study to Assess the Safety of a New Formulation of BLP25 Liposome Vaccine in Patients with Unresectable Stage III Non-Small-Cell Lung Cancer" was published online in advance of print publication in the November issue of the journal Clinical Lung Cancer.
The results demonstrated a two-year survival rate of 64 percent (95 percent confidence interval, 44-84 percent) in patients (N=22) with unresectable stage III non-small cell lung cancer after a median follow-up period of 26.7 months. The most common adverse events in this trial were injection site reactions, fatigue and influenza-like illness, which are similar to those seen in other reported trials of Stimuvax. The Phase 1/2 trial, initiated by Oncothyreon in 2005, was completed by Merck KGaA of Darmstadt, Germany, which assumed responsibility for the clinical development of Stimuvax in 2007.
"The two-year survival rate seen in this study is similar to the 57% two-year survival rate seen in a similar cohort of patients in Oncothyreon's Phase 2b trial of Stimuvax," said Robert Kirkman, M.D., President and CEO of Oncothyreon. "Encouragingly, 11 of the 22 patients in this trial, all of whom were enrolled in the trial in 2005, are currently alive, with 8 of them continuing on Stimuvax therapy and free of documented disease progression."
Merck KGaA has an exclusive world-wide license from Oncothyreon for Stimuvax. Merck KGaA is investigating the use of Stimuvax (BLP25 liposome vaccine) in the treatment of NSCLC in the Phase 3 START and INSPIRE trials. The vaccine was granted fast-track status in September 2004 by the FDA. Stimuvax is being developed in Europe by Merck KGaA and in the United States and Canada by its affiliate, EMD Serono Inc.
START is a multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical study designed to evaluate the efficacy, safety and tolerability of Stimuvax in subjects suffering from unresectable stage IIIA or IIIB NSCLC who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. The study will involve more than 1,300 patients in approximately 30 countries. The primary endpoint of the trial is overall survival.
The INSPIRE study is a multi-center, Phase 3, double-blind, placebo-controlled, randomized clinical trial designed to evaluate the efficacy, safety and tolerability of Stimuvax in subjects suffering from unresectable, stage IIIA or IIIB NSCLC who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. The design of the INSPIRE study is almost identical to the START study. The study will enroll approximately 420 unresectable, stage III NSCLC patients across China, Hong Kong, Korea, Singapore and Taiwan.
Oncothyreon is a biotechnology company specializing in the development of innovative therapeutic products for the treatment of cancer. Oncothyreon's goal is to develop and commercialize novel synthetic vaccines and targeted small molecules that have the potential to improve the lives and outcomes of cancer patients. For more information, visit www.oncothyreon.com.
This press release contains statements that are forward-looking, including Oncothyreon's expectations regarding the clinical development program for Stimuvax and the ability of Stimuvax to impact patient survival. These forward-looking statements involve risks and uncertainties, many of which are beyond Oncothyreon's control. These risks, uncertainties and other factors could cause actual results to differ materially from those projected in forward-looking statements. Specifically, there is no assurance that the results of preclinical studies or clinical trials will be predictive of either safety or efficacy in future clinical trials. This and other risks could materially and adversely affect the Company's business, results of operations and the trading price of its common stock. For a detailed description of risks and uncertainties faced by the Company, you are encouraged to review the official corporate documents filed with the securities regulators in the United States on U.S. EDGAR. The Company does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.
Additional information relating to Oncothyreon can be found on U.S. EDGAR at www.sec.gov.
SOURCE Oncothyreon Inc.