SEATTLE, Dec. 10 /CNW/ - Oncothyreon Inc. (Nasdaq: ONTY) today announced that Merck KGaA of Darmstadt, Germany, has initiated a Phase 3 trial of Stimuvax(R) (BLP25 liposome vaccine) in Asian patients with advanced non-small cell lung cancer (NSCLC). The trial, named INSPIRE (Stimuvax trial In Asian NSCLC Patients: Stimulating Immune Response), is anticipated to enroll approximately 420 patients in China, Hong Kong, South Korea, Singapore and Taiwan.
INSPIRE is similar in design to START, the ongoing global Phase 3 trial of Stimuvax in NSCLC. Each trial is a multi-national, Phase 3, double-blind, placebo-controlled, randomized clinical trial to evaluate the efficacy, safety and tolerability of Stimuvax in patients with unresectable, stage III NSCLC who have demonstrated either stable disease or an objective response following primary chemo-radiotherapy. The primary endpoint of both trials is overall patient survival.
Stimuvax is an investigational therapeutic cancer vaccine being developed by Merck KGaA under a license agreement with Oncothyreon. Stimuvax is designed to stimulate the body's immune system to identify and target cancer cells that express MUC1, an antigen commonly expressed in NSCLC as well as in other common cancer types such as breast cancer, multiple myeloma, and colorectal, prostate and ovarian cancers. Stimuvax was the first investigational cancer vaccine to enter Phase 3 clinical testing in NSCLC with the launch of the START study in February 2007. A Phase 2 trial of Stimuvax in NSCLC is ongoing in Japan. Stimuvax is also being investigated in the Phase 3 STRIDE study, which is currently enrolling patients who have hormone receptor-positive, locally advanced, recurrent or metastatic breast cancer.
"With the initiation of this third Phase 3 trial of Stimuvax, our partner Merck KGaA again has demonstrated its commitment to the global development of Stimuvax," said Robert L. Kirkman, M.D., President and Chief Executive Officer of Oncothyreon. "We are grateful for this commitment to patients worldwide with unmet medical needs and for the investigation of Stimuvax in multiple, difficult-to-treat cancers."
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 future clinical development plans 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, the indications for which Stimuvax might be developed, and Merck KGaA's development plans for Stimuvax. There can be no guarantee that the results of preclinical studies or clinical trials will be predictive of either safety or efficacy in future clinical 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 with the securities regulators in the United States on U.S. EDGAR and in Canada 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.
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