VIENNA, Va., Dec. 1 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, MultikineŪ. 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.
Multikine, a patented defined mixture of naturally derived cytokines, is the first immunotherapeutic agent in a new class of drugs called "Immune SIMULATORS". Immune SIMULATORS simulate the way our natural immune system acts in defending us against cancer. As opposed to other immunotherapies which are designed to target a single or limited number of specific antigens or molecules, Immune SIMULATORS are multi-targeted; they simultaneously cause a direct and targeted killing of the specific tumor cells and they activate the immune system to produce a stronger anti-tumor attack on multiple fronts.
Multikine is also the first immunotherapeutic agent being developed as a first-line standard of care treatment for cancer. It is administered prior to any other cancer therapy because that is the period when the anti-tumor immune response can still be fully activated. Once the patient has advanced disease, or had surgery or has received radiation and/or chemotherapy, the immune system is severely weakened and is less able to mount an effective anti-tumor immune response. Other immunotherapies are administered after the patient has received chemotherapy and/or radiation therapy, which can limit their effectiveness.
About CEL-SCI Corporation
CEL-SCI Corporation is developing products that empower immune defenses. Its lead product is Multikine which is being readied for a global Phase III trial in advanced primary head and neck cancer. CEL-SCI is also developing a vaccine to treat H1N1 hospitalized patients using its L.E.A.P.S.(TM) technology platform. This investigational treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu as CEL-SCI scientists are very concerned about the creation of a new more virulent hybrid virus through the combination of H1N1 and Avian Flu, or maybe Spanish Flu. The Company has operations in Vienna, Virginia, and Baltimore, Maryland.
For more information, please visit www.cel-sci.com.
When used in this report, the words "intends," "believes," "anticipated" and "expects" and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties which could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI Corporation's SEC filings, including but not limited to its report on Form 10- K/A for the year ended September 30, 2008. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
SOURCE CEL-SCI Corporation