Merck Vaccine Trial Halted After Encephalitis Case

FDAnews Drug Daily Bulletin

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.
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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.