Merck Serono, EMD Serono suspend global clinical development program for Stimuvax temporarily

Oncothyreon Inc. (Nasdaq: ONTY) today announced that Merck Serono, a division of Merck KGaA of Darmstadt, Germany, and its U.S. affiliate, EMD Serono, Inc., have temporarily suspended the worldwide clinical development program for Stimuvax(R) (BLP25 liposomal vaccine). The suspension is the result of a suspected unexpected serious adverse reaction in a patient with multiple myeloma participating in an exploratory clinical trial. This decision was taken in alignment with the U.S. Food and Drug Administration's (FDA) clinical hold placed on the Investigational New Drug (IND) application for Stimuvax.

The suspension affects the Phase 3 clinical program for Stimuvax, including the START and INSPIRE trials in non-small cell lung cancer (NSCLC) and the STRIDE trial in breast cancer. Further recruitment of patients into all trials actively recruiting patients and ongoing treatment with Stimuvax in these trials are suspended.

"Patient safety is of paramount importance to Merck Serono and to Oncothyreon," said Robert L. Kirkman, M.D., President and CEO of Oncothyreon. "We understand that Merck Serono is working closely with the FDA, other regulatory agencies and the patient's physicians to evaluate the implications of this adverse reaction and to determine an appropriate course of action."

The exploratory trial in multiple myeloma is designed to investigate the mechanism of action of Stimuvax and the effect of cyclophosphamide on regulatory T cells, which may affect the response to the therapeutic vaccine. The adverse event occurred in a patient receiving a more intensive regimen of low-dose cyclophosphamide than is utilized in the Phase 3 program. The patient developed an encephalitis, or inflammation of the brain. No other events of this kind have been reported in other trials of Stimuvax to date.

SOURCE Oncothyreon Inc.