CEL-SCI has begun a phase III clinical trial for Multikine, its flagship immunotherapy drug for head and neck cancer. 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, Immunotherapy Multikine Anti Tumor Treatments (IT-MATTERS), is believed to be the largest head and neck cancer study ever conducted, CEL-SCI said in a press release. The company expects to enroll approximately 880 patients at about 48 clinical centers in nine countries (U.S., Canada, Hungary, Poland, Ukraine, Russia, India, Israel, and Taiwan) in the 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, and controlled, and patients are prospectively stratified.
CEL-SCI has selected the primary end point as increased overall survival -- the most stringent end point that can be chosen for a cancer clinical trial. A 10% absolute increase in overall survival in the Multikine arm of the study over what can be achieved with current standard of care therapy alone is currently considered a clinically meaningful result for this patient population by the medical community. Based on the results of the company's proof-of-concept phase II study, which demonstrated that Multikine has the potential to increase overall survival by 33%, CEL-SCI believes it can demonstrate at least a 10% absolute increase in overall survival of subjects treated with Multikine.
In addition to assessing the primary end point of overall survival, the trial will undertake an extensive microscopic examination of the pathology of the head and neck cancers treated with Multikine. These pathology studies will allow the company to observe immune responses to Multikine at the cellular level.
In a separate in vitro laboratory study being conducted in collaboration with experts at the National Institutes of Health (NIH) on biopsy specimens collected from consenting study subjects, researchers will perform genetic tests and conduct and analyze data that should shed further light on the mechanism of action of Multikine down to the genetic and molecular level, according to the company.
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