Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) and CEL-SCI Corporation (AMEX: CVM) have set up the first center in Israel for CEL-SCI's Phase III clinical trial for Multikine(R), the company's flagship cancer immunotherapy for the treatment of neck and head cancer. The first site in Israel for the trial is at Sourasky Medical in Tel Aviv, Israel. Patient enrollment is expected to start soon.
Teva plans to sign up another two Israeli clinical centers to conduct the trial, which is already ongoing at multiple clinical sites in the US, Canada, Poland, Hungary, Taiwan and India.
CEL-SCI said that the overall study is expected to enroll about 880 head and neck cancer patients in over 40 hospitals in nine countries.
Teva holds exclusive marketing rights to sell Multikine in Israel and Turkey.
CEL-SCI CEO Geert Kersten said, "We are pleased to partner with Teva for this pivotal study. Teva has significant experience and expertise in conducting clinical trials, and we are excited about the relationship we have established with the company as we conduct this Phase III trial. The trial is designed to demonstrate that Multikine represents a new paradigm in the treatment of head and neck cancer."
Phase II clinical trials of Multikine demonstrated the product was safe and well-tolerated and eliminated tumors in 12% of the subjects less than a month into treatment. The Multikine treatment regimen was also shown to kill, on average, about half of the cancer cells in the subjects' tumors before the start of standard therapy. Follow-up studies of subjects enrolled in the "proof of concept" Phase II trial showed a 33% improvement in the survival rate of those treated with Multikine at a median of three and a half years following surgery.
The US Food and Drug Administration (FDA) granted orphan drug status to Multikine in the neoadjuvant therapy of patients with squamous cell carcinoma of the head and neck.
Published by Globes, Israel business news - www.globes-online.com - on June 27, 2011
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