CEL-SCI Corporation (NYSE Amex: CVM), a late-stage oncology company and a developer of vaccines and therapeutics for the prevention and treatment of infectious diseases, announced today that it has retained the services of an international Contract Research Organization (CRO) to run CEL-SCI's upcoming Phase III clinical trial in advanced primary head and neck cancer with the Company's lead product candidate, Multikine®. This CRO is considered to be one of the world's top CRO's for running global oncology studies.
The impending Phase III trial is expected to enroll up to 800 patients with advanced primary head and neck cancer in multiple countries around the world. It will evaluate Multikine's ability to increase the overall survival of treated patients when used in conjunction with the current standard of care treatment.
"We are very pleased to have retained the services of a well respected and internationally recognized CRO which specializes in conducting late-stage oncology trials to guide our pivotal Phase III trial for Multikine," said Geert Kersten, Chief Executive Officer of CEL-SCI. "After carefully evaluating many competing organizations, we have chosen this CRO based on their extensive experience in managing global clinical trials of medicines ultimately approved for the treatment of cancer."
In Phase II clinical trials Multikine was shown to be safe and well-tolerated, and to improve patients' overall survival by 33% at a median of three and a half years following surgery. The U.S. Food and Drug Administration (FDA) gave the go-ahead for a Phase III clinical trial and granted orphan drug status to Multikine in the neoadjuvant therapy of squamous cell carcinoma (cancer) of the head and neck. CEL-SCI recently took delivery of its new state of the art manufacturing facility which will produce Multikine for the upcoming Phase III trial.
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