Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 Merck Serono Suspends Stimuvax Trials | Contract Pharma

What are you searching for?

Sign in

Merck Serono Suspends Stimuvax Trials

Merck Serono has 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.

Author Image

By: Tim Wright

Editor-in-Chief, Contract Pharma

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.”

Add us as a preferred source on Google

Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Add Contract Pharma as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters