Merck commences Stimuvax Phase 3 trial in Asian patients with NSCLC

Dec 10 2009

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."