EMD Serono Resumes Stimuvax Program

EMD Serono, Inc., an affiliate of Merck KGaA, is resuming its Stimuvax (BLP25 liposome vaccine) clinical program in patients with non-small cell lung cancer (NSCLC), which includes a pair of Phase III studies. The studies will restart after approval by the local regulatory authorities and ethics committees.

“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.

Resuming the program follows the FDA’s decision to partially lift the clinical hold it placed on the IND application for BLP25 liposome vaccine in March 2010. The clinical hold was based on an unexpected serious adverse reaction (SUSAR) of encephalitis observed in a patient enrolled in a Phase II trial of BLP25 in patients with multiple myeloma. The company’s Phase III STRIDEc trial in advanced breast cancer remains on clinical hold by the FDA. Merck KGaA will continue to work with the health authorities to decide the next steps for this trial.