BELLEVUE, WA, June 2 /PRNewswire-FirstCall/ - Oncothyreon Inc. today announced the presentation of two-year survival data from a Phase 1/2 multicenter study of Stimuvax(R) (BLP25 liposomal vaccine) in patients (n=22) with unresectable stage III non-small cell lung cancer. After a median follow-up period of 26.7 months, the two-year overall survival rate was 64 percent (95 percent confidence interval, 44-84 percent). The data were presented by Dr. N. R. Murray, British Columbia Cancer Agency, Fraser Valley Center, Surrey, British Columbia, Canada, at the American Society of Clinical Oncology Annual Meeting in Chicago on June 1, 2008.
“The two-year overall survival data in the current study are similar to the overall survival seen in a similar cohort of patients in Oncothyreon’s prior Phase 2b trial of Stimuvax,” said Robert L. Kirkman, M.D., President and CEO of Oncothyreon. “In that prior study, the two-year overall survival in patients with Stage IIIb loco-regional disease was 57 percent in those treated with Stimuvax plus best supportive care compared with 33 percent in those who received best supportive care alone. We are very encouraged that the new data, obtained in the same patient population and with the same formulation of Stimuvax being used in the ongoing Phase 3 trial, are supportive of our prior results.”
The Phase 1/2 trial was designed to evaluate the safety of Stimuvax following a change in the manufacturer of the adjuvant component of the vaccine. No new safety concerns were identified in the study. The trial was completed by Merck KGaA of Darmstadt, Germany, which assumed responsibility for the clinical development of Stimuvax in 2007.
Merck KGaA currently is conducting a global Phase 3 trial of Stimuvax known as START (Stimulating Targeted Antigenic Responses To NSCLC). START 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 Phase 3 trial is expected to enroll more than 1,300 patients in approximately 30 countries. For more information on the START trial, or to find a participating center and eligibility criteria, log on to www.nsclcstudy.com or www.clinicaltrials.gov.
About Stimuvax
Stimuvax is an investigational therapeutic cancer vaccine designed to induce an immune response to cancer cells that express MUC1, a glycoprotein antigen widely expressed on common cancers. MUC1 is over expressed on many cancers such as lung cancer, breast cancer, prostate cancer and colorectal cancer. Stimuvax is thought to work by stimulating the body’s immune system to identify and destroy cancer cells expressing MUC1.
About Oncothyreon
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.
Forward-Looking Statements
In order to provide Oncothyreon’s investors with an understanding of its current intentions and future prospects, this release contains statements that are forward looking, including statements related to payments Oncothyreon may expect to receive; the therapeutic and commercial potential of Stimuvax; future clinical development plans; the details of clinical trials; and the anticipated future size of the market for Stimuvax. These forward-looking statements represent Oncothyreon’s intentions, plans, expectations and beliefs and are based on its management’s experience and assessment of historical and future trends and the application of key assumptions relating to future events and circumstances.
Forward-looking statements involve risks and uncertainties, including risks and uncertainties related to Oncothyreon’s business and the general economic environment. Many of these risks and uncertainties are beyond Oncothyreon’s control. These risks, uncertainties and other factors could cause our actual results to differ materially from those projected in forward-looking statements. Risks, uncertainties, and assumptions include those predicting the timing, duration and results of clinical trials, the timing and results of regulatory reviews, the safety and efficacy of Stimuvax, and the possibility of future milestone and royalty payments. There can be no guarantee that the results of earlier trials will be predictive of either safety or efficacy in future trials. These and other risks and uncertainties are described in the reports and other documents filed by Oncothyreon Inc. with the SEC and/or Canadian regulatory authorities.
Although Oncothyreon believes that any forward-looking statements contained herein are reasonable, it can give no assurance that its expectations are correct. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For a detailed description of the risks and uncertainties associated with Oncothyreon, you are encouraged to review the official corporate documents filed by Oncothyreon Inc. with the securities regulators in United States and Canada with the SEC and on SEDAR. Oncothyreon is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
Additional Information
Additional information relating to Oncothyreon can be found on U.S. EDGAR at www.sec.gov and on SEDAR at www.sedar.com.
CONTACT: Investor and Media Relations Contact: Julie Rathbun, Rathbun
Communications, (206) 769-9219, ir@oncothyreon.com
