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SIRO Clinpharm, Peregrine Complete Trial in India

Phase II trial studied Cotara in GBM

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By: Tim Wright

Editor-in-Chief, Contract Pharma

SIRO Clinpharm, a CRO with a presence in Asia, Europe and U.S., has completed a trial project for Peregrine Pharmaceuticals, a clinical-stage biopharma developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections.
 
The Phase II trial in India involved recurrent glioblastoma multiforme (GBM) patients treated with Cotara, an investigational radiopharmaceutical product. SIRO was assigned to identify and manage the Indian arm of the trial across multiple sites, and enrolled the majority of patients. 
 
Joseph S. Shan, M.P.H., Peregrine’s vice president of Clinical and Regulatory Affairs, said, “We are pleased to be associated with SIRO Clinpharm, as SIRO brings expertise in the field of clinical research and has connected us with investigators experienced in conducting GBM trials. SIRO has the capability to execute complex clinical studies and they have provided us with experienced investigators, state-of-the-art research facilities, and quality monitoring, which are critical elements for well-controlled clinical trials.”
 
Dr. Ajit Nair, president, Global Operations, SIRO Clinpharm, said, “It is indeed a pleasure to be associated with Peregrine which has entrusted faith in us as a company. Treating recurrent GBM is extremely challenging, but with proper planning and meticulous execution by the SIRO Project Team and Project Manager, we could achieve our goal. This trial has reaffirmed the fact that investigators in India are not only capable of handling complex clinical trials, but also comply with stringent regulatory international standards.”

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