Stimuvax clinical program resumed in patients with NSCLC

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, today announced that they are resuming their Stimuvax^® (BLP25 liposome vaccine) clinical program in patients with non-small cell lung cancer (NSCLC) which includes the Phase III studies, START and INSPIRE. The treatment and enrollment in these studies will restart after approval by the local regulatory authorities and ethics committees.

“Merck KGaA worked constructively with the FDA and other health authorities to address the questions raised on the safety of BLP25 liposome vaccine in patients with NSCLC and, as a result, we can now resume our NSCLC clinical program”

"Merck KGaA remains highly committed to the development of BLP25 liposome vaccine and the well-being of the patients. We believe this therapeutic cancer vaccine has the potential to be a valuable addition to the future range of therapies for oncologists and their patients," said Dr. Wolfgang Wein, Executive Vice President, Oncology, Merck KGaA.

This announcement follows a decision by the U.S. Food and Drug Administration (FDA) to partially lift the clinical hold it placed on the Investigational New Drug (IND) application for BLP25 liposome vaccine in March 2010 and allow the START trial to be resumed.

"Merck KGaA worked constructively with the FDA and other health authorities to address the questions raised on the safety of BLP25 liposome vaccine in patients with NSCLC and, as a result, we can now resume our NSCLC clinical program," commented Dr. Bernhard Kirschbaum, Head of Global Research and Development, Merck KGaA. "We have meanwhile received a number of regulatory approvals to restart in other countries and await approval in the remaining countries."

The study that remains on clinical hold by the FDA is the Phase III STRIDE^c trial in advanced breast cancer. Merck KGaA will continue to work closely with the health authorities, including the FDA, to decide the next steps for this trial.

"The resumption of the BLP25 liposome vaccine clinical program is very good news for the oncology community and NSCLC patients. If the START and INSPIRE Phase III trials are successful, BLP25 liposome vaccine could play an important role in the treatment of these currently underserved patients," said Dr. Frances Shepherd, Director of the Medical Oncology Princess Margaret Hospital in Toronto, Ontario, Canada, and Coordinating Investigator of the START trial.

Merck KGaA temporarily suspended its global clinical program for BLP25 liposome vaccine in all recruiting studies worldwide following the clinical hold put in place by the FDA in March 2010. The clinical hold followed a suspected unexpected serious adverse reaction (SUSAR) of encephalitis, observed in a patient enrolled in an exploratory Phase II trial of BLP25 liposome vaccine in patients with multiple myeloma. To ensure the safety of the study subjects, the protocols in the NSCLC trials are being amended to add specific safety measures.