CEL-SCI kicks off long awaited Phase III study Print E-mail
By Staff and Wire Reports   
Wednesday, 29 December 2010 07:55
best penny picksJust as we told susbscribers they would last week, CEL-SCI Corporation (AMEX: CVM) finally announced today that it has commenced its Phase III clinical trial for Multikine, the Company’s flagship immunotherapy.

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It has been a long road for CEL-SCI to this point, but the company has now completed all of the manufacturing and regulatory requirements to begin enrollment of the study. The goal is to establish Multikine as a first-line standard of care therapy in treating newly diagnosed head and neck cancer patients. The trial is believed to be the largest head and neck cancer study ever conducted.

We have long been following the developments at CEL-SCI and believe this is a critical development for not only the company, but for the entire immunotherapy sub-sector as well. "What I like most about the Multikine trial  is that finally we will get to see one of these immunotherapeutic cancer treatments at work before a patients immune system has been ravaged by radiation and chemotherapy treatments," writes BioMedReports contributor Vinny Cassano, who has toured the $25 million state-of-the-art manufacturing facility that will produce the innovative drug candidate. "Common sense would indicate that an immunotherapeutic treatment would work best while a patient's immune system was still strong, and this trial could be a groundbreaking opportunity to test that theory."

When we started writing about the company in 2009, they didn't have enough capital to move to Phase III, but the company is now prepared to enroll approximately 880 patients at about 48 clinical centers in 9 countries (USA, Canada, Hungary, Poland, Ukraine, Russia, India, Israel and Taiwan) in the IT-MATTERS trial. CEL-SCI’s partners Teva Pharmaceuticals and Orient Europharma will conduct parts of the Phase III study in Israel and Taiwan respectively. All study sites, including those in Israel and Taiwan, are under the control of CEL-SCI’s global Clinical Research Organization. The trial is open label, randomized, controlled and patients are prospectively stratified.

“We are very excited to begin this pivotal study,” said Geert Kersten, Chief Executive Officer of CEL-SCI. “Our team believes that all of the necessary measures have been taken to maximize the probability of a successful outcome for the study.”

Eyal Talor, Chief Scientific Officer of CEL-SCI said: “We believe that by investing so much time, financial resources and effort ahead of this study, we have increased the likelihood that the data derived from the study will be of the type and quality required by regulators worldwide to support the applications for marketing approval. We hope to have all 48 clinical sites enrolling patients within a few months, a very fast timeline considering that this study is run in 9 countries on 3 continents.”

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