03.23.10
Merck Serono, a division of Merck KGaA, and its U.S. affiliate, EMD Serono, have temporarily suspended the worldwide clinical development program for Stimuvax (BLP25 liposomal vaccine) due to an unexpected serious adverse reaction in a patient with multiple myeloma. The FDA has also placed a clinical hold on the IND application.
The suspension of the Phase III clinical program for Stimuvax includes the START and INSPIRE trials in non-small cell lung cancer (NSCLC) and the STRIDE trial in breast cancer.
Merck KGaA has an exclusive worldwide license from Oncothyreon, Inc. for Stimuvax. 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 U.S. by EMD Serono.
"Patient safety is of paramount importance to Merck Serono and to Oncothyreon," said Robert L. Kirkman, M.D., president and chief executive officer 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 suspension of the Phase III clinical program for Stimuvax includes the START and INSPIRE trials in non-small cell lung cancer (NSCLC) and the STRIDE trial in breast cancer.
Merck KGaA has an exclusive worldwide license from Oncothyreon, Inc. for Stimuvax. 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 U.S. by EMD Serono.
"Patient safety is of paramount importance to Merck Serono and to Oncothyreon," said Robert L. Kirkman, M.D., president and chief executive officer 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."