Stimuvax® is an innovative cancer vaccine designed to induce an immune response to cancer cells that express MUC1, a protein antigen widely expressed on common cancers. MUC1 is over expressed on many cancers such as lung cancer, breast cancer, prostate cancer and colorectal cancer. Stimuvax is thought to work by stimulating the body's immune system to identify and destroy cancer cells expressing MUC1.
Stimuvax is being developed by Merck KGaA of Darmstadt, Germany (Merck) under a license agreement with Oncothyreon. Merck is currently conducting three Phase 3 trials of Stimuvax.
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.
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