Adverse event halts Merck cancer vaccine trial

pharmafile | March 23, 2010 | News story | Research and Development Merck KGaA, Merck Serono, Stimuvax, vaccines 

Trials of a new vaccine which helps fight cancer have been halted after one patient developed encephalitis, a potentially fatal swelling of the brain.

Stimuvax (BLP25 liposome vaccine) is being developed by Germany’s Merck KGaA as a treatment for various cancers, and is one of a handful of new ‘therapeutic vaccines’, which use the mechanism of vaccines to treat tumours.

The trial in question was a phase II exploratory trial in patients with multiple myeloma.

The patient was randomised to an experimental arm of Stimuvax in combination with an intensified schedule of low-dose cyclophosphamide, which is not used in the other Stimuvax studies.

The company has not disclosed further details about the patient’s condition, but all trials of the drug have been suspended as a precaution.

The vaccine is already in phase III trials for non-small cell lung cancer (NSCLC) and breast cancer, and these trials have also been halted in order to allow a safety review to take place.

The company says it will work closely with regulators to evaluate the implications of the adverse reaction for Stimuvax and determine the most suitable course of action.

Stimuvax was granted fast-track status in September 2004 by the FDA. Merck acquired exclusive worldwide licensing rights for Stimuvax from US company Oncothyreon, and is overseeing trials in Europe and the US. 

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