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news.EMD Serono, an affiliate of Merck KGaA, Darmstadt, has resumed Stimuvax (BLP25 liposome vaccine) clinical program in patients with non-small cell lung cancer (NSCLC) which includes the Phase III studies, STARTa and INSPIREb.
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The treatment and enrollment in these studies is expected to restart after approval by the local regulatory authorities and ethics committees.
The announcement follows a decision by the FDA to partially lift the clinical hold it placed on the investigational new drug (IND) application for BLP25 liposome vaccine in March 2010 and allow the START trial to be resumed.
The study that remains on clinical hold by the FDA is the Phase III STRIDEc trial in advanced breast cancer. Merck KGaA will continue to work closely with the health authorities, including the FDA, to decide the next steps for this trial.
Merck KGaA temporarily suspended its global clinical program for BLP25 liposome vaccine in all recruiting studies worldwide following the clinical hold put in place by the FDA in March 2010.
Merck KGaA said that the clinical hold followed a suspected unexpected serious adverse reaction (SUSAR) of encephalitis, observed in a patient enrolled in an exploratory Phase II trial of BLP25 liposome vaccine in patients with multiple myeloma. To ensure the safety of the study subjects, the protocols in the NSCLC trials are being amended to add specific safety measures.
Bernhard Kirschbaum, head of global research and development at Merck KGaA, said: “Merck KGaA 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 program. We have meanwhile received a number of regulatory approvals to restart in other countries and await approval in the remaining countries.”
Frances Shepherd, coordinating investigator of the START trial, said: “The resumption of the BLP25 liposome vaccine clinical program is very good news for the oncology community and NSCLC patients. If the START and INSPIRE Phase III trials are successful, BLP25 liposome vaccine could play an important role in the treatment of these currently underserved patients.”