Merck Serono Suspends Stimuvax Clinical Programme

24 March 2010 (Last Updated March 24th, 2010 18:30)

Merck Serono, a division of Merck KGaA, has temporarily suspended all clinical programmes for Stimuvax (BLP 25 liposome vaccine) following a suspected serious adverse reaction. The suspension comes in line with the FDA's decision to place a hold on the company's investigational new drug

Merck Serono, a division of Merck KGaA, has temporarily suspended all clinical programmes for Stimuvax (BLP 25 liposome vaccine) following a suspected serious adverse reaction.

The suspension comes in line with the FDA's decision to place a hold on the company's investigational new drug application for Stimuvax, which has shown potential for the treatment of non-small cell lung cancer and breast cancer.

A patient participating in the Phase II exploratory clinical trial developed encephalitis after receiving Stimuvax in combination with an intensified schedule of low-dose cyclophosphamide, not used in the other Stimuvax studies.

Merck Serono is investigating the cause of the adverse reaction.