VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE AMEX: CVM) today provided an update on its planned Phase III clinical trial of its cancer immunotherapy drug candidate Multikine®. The Company, together with its development partners Teva Pharmaceutical Industries and Orient Europharma, has already selected 40 of the planned 50 global medical centers where the Multikine Phase III study will be conducted. In addition, all major vendors for the study have now been chosen. CEL-SCI expects to enroll the first patient in the study during the third quarter of 2010.
The trial is expected to be the largest head and neck cancer clinical study ever conducted, with more than 800 patients expected to be enrolled worldwide. It will also be the first Phase III study in the world in which cancer immunotherapy is given to treatment naïve patients - before surgery, radiation and/or chemotherapy. This is believed to be the best time to stimulate an anti-tumor immune response as the immune system is still competent.
“We are eager to commence the pivotal study to validate Multikine as the standard of care for newly diagnosed head and neck cancer patients,” said Geert Kersten, CEL-SCI’s Chief Executive Officer. “We look forward to confirming the promising results that Multikine has already demonstrated in earlier clinical trials. We have taken every step to both minimize risk and maximize our chances for success.”
Mr. Kersten continued, ”If the huge success of Dendreon’s Provenge® has defined the first generation of cancer immunotherapy, we expect our Multikine to define the second generation. Multikine is an off the shelf product making large commercial production possible, it contains both passive and active immunity and is given before any other cancer therapy, a time when cancer immunotherapy should be most successful.”
In Phase II clinical trials Multikine was shown to be safe and well-tolerated, and to eliminate the tumor in 12% of the patients after only three weeks of treatment. This patient response preceded the commencement of the current treatment regimen which includes one or a combination of surgery, radiation and chemotherapy. Follow-up showed an improvement in the Multikine treated 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 patients having squamous cell carcinoma (cancer) of the head and neck.
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 surgery, 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 an immunotherapy (LEAPS-H1N1-DC) to treat H1N1 hospitalized patients and a vaccine (CEL-2000) for Rheumatoid Arthritis using its L.E.A.P.S.TM technology platform. The LEAPS-H1N1-DC 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. This investigational treatment is currently being tested in a clinical study at Johns Hopkins University. The Company has operations in Vienna, Virginia, and in/near 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, 2009. 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.
Gavin de Windt, 703-506-9460
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