April 7, 2010
Merck Serono, a division of Merck KGaA, has suspended enrollment and treatment of patients in ongoing worldwide studies of its therapeutic vaccine Stimuvax, following a suspected unexpected serious adverse reaction (SUSAR). The FDA placed a clinical hold on the investigational NDA for Stimuvax (BLP25 liposome vaccine), which is now in Phase III for non-small cell lung cancer and breast cancer. Investigators observed the SUSAR in a Phase II exploratory trial evaluating the drug in combination with cyclophosphamide in patients with multiple myeloma.
Clinical Trials Advisor