Merck Serono resumes Stimuvax trials in lung cancer vaccine as FDA lifts clinical hold

Following a decision by the US Food and Drug Administration to lift a clinical hold imposed on trails of Merck Serono's Stimuvax (BLP25 liposome vaccine), the Swiss unit of German drug major of Merck KGaA and its US affiliate, EMD Serono, are resuming the program.

The halted Stimuvax clinical program was in patients with non-small cell lung cancer (NSCLC) which includes the Phase III studies, STARTa and INSPIREb (The Pharma Letter March 23). The trial was stopped after a multiple myeloma patient in a Phase II trial developed encephalitis. The treatment and enrollment in these new studies will restart after approval by the local regulatory authorities and ethics committees, the company said.

Merck is studying Stimuvax ' licensed from US firm Oncothyreon - in a range of malignancies, including non-small cell lung cancer and breast tumors, and the vaccine may generate as much as $1 billion in annual sales, chief executive Karl-Ludwig Kley has said. However, the German drugmaker is racing with biotechnology firms such as Transgene, Dendreon and Antigenics to bring cancer vaccines to market.