Trials of cancer vaccine Stimuvax can resume

Merck Serono has been given clearance to resume part of its clinical trials of its cancer vaccine Stimuvax.

Trials of the cutting edge cancer treatment were halted in March after one patient in phase II trials for multiple myeloma developed encephalitis, a potentially fatal swelling of the brain.

The FDA has now told the company it can resume its non-small cell lung cancer (NSCLC) trials, which include the phase III studies, STARTa and INSPIREb.

The protocols in the NSCLC trials are to be amended to add specific safety measures.

However the phase III STRIDEc trials for advanced breast cancer remain suspended. Merck Serono says it will continue to work with regulators to decide the next steps for the trial.

Treatment and enrollment in the other studies will restart after approval by the local regulatory authorities and ethics committees.

“Merck Serono remains highly committed to the development of BLP25 liposome vaccine and the well-being of the patients. We believe this therapeutic cancer vaccine has the potential to be a valuable addition to the future range of therapies for oncologists and their patients,” said Dr Wolfgang Wein, executive vice president of oncology at Merck Serono.

Stimuvax is a BLP25 liposome vaccine, and works by stimulating the body’s own immune system to attack cancer cells. The vaccine was granted fast-track status for NSCLC in September 2004 by the FDA. Merck KGaA licensed the drug from US biotech company Oncothyreon.

“Merck Serono worked constructively with the FDA and other health authorities to address the questions raised on the safety of BLP25 liposome vaccine in patients with NSCLC and, as a result, we can now resume our NSCLC clinical programme,” commented Dr Bernhard Kirschbaum, head of global research and development at Merck Serono.

“We have meanwhile received a number of regulatory approvals to restart in other countries and await approval in the remaining countries.”

Andrew McConaghie