Statistically significant data suggests potential to treat certain patients taking statins without side effects
VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE Amex: CVM) announced today data from its Phase II clinical studies which showed that its lead drug Multikine was able to lower cholesterol in studies involving 120 head and neck cancer patients. The studies were primarily designed to determine the safety and efficacy of the drug in head and neck cancer patients. However, a meta-analysis of the pooled clinical data from the four clinical trials showed the reduction of total cholesterol following treatment with Multikine to be highly statistically significant (p<0.0001). This result was achieved without affecting the levels of AST/ALT (liver enzymes) or having any other severe adverse effects related to Multikine in these patients.
Unlike the liver toxicity seen with the widely prescribed cholesterol-lowering drugs called statins (e.g. Lipitor, Zocor, Mevacor), patients undergoing treatment with Multikine showed no liver toxicity while achieving reduction in total cholesterol levels. Most of the patients were treated with Multikine for 2 or 3 weeks, but some of them were treated for up to 24 weeks.
A meta-analysis is a statistical procedure to combine a number of existing studies. Through such a procedure, effects which are hard or impossible to discern in the original smaller studies can be made visible as the meta-analysis is, in the ideal case, equivalent to a single study with the combined size of all the original studies.
The Company expects its ongoing Phase III trial, which is the largest study ever conducted in head and neck cancer, to generate additional data on the effect that Multikine has on lowering cholesterol. The study is run in 9 countries and partnered with Teva Pharmaceuticals and Orient Europharma. This Phase III clinical trial is an open-label, randomized, controlled, multi-center study designed to determine if Multikine administered prior to current standard of care (Surgery plus Radiotherapy or Surgery plus Concurrent Radiochemotherapy) used for treatment naive subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate (Head and Neck cancer) will result in an increased overall rate of survival versus the subjects treated with standard of care only. It will also be the first trial in which immunotherapy will be administered before any other traditional means of care are attempted. A detailed description of the study can be found at http://www.clinicaltrials.gov/ct2/show/NCT01265849?term=multikine&rank=1.
The goal of this study is to establish Multikine as a first-line standard of care therapy in treating newly diagnosed head and neck cancer patients. The trial is called “IT-MATTERS,” an acronym for: Immunotherapy Multikine Anti Tumor Treatments.
The “proof of concept” Phase II clinical trial of Multikine demonstrated the product was safe and well-tolerated and eliminated tumors in 12% of the subjects less than a month into treatment. The Multikine treatment regimen was also shown to kill, on average, about half of the cancer cells in the subjects’ tumors before the start of standard therapy. Follow-up studies of subjects enrolled in the “proof of concept” Phase II trial showed a 33% improvement in the survival rate of those treated with Multikine at a median of three and a half years following surgery. The U.S. Food and Drug Administration granted orphan drug status to Multikine in the neoadjuvant therapy of patients with squamous cell carcinoma of the head and neck.
About CEL-SCI Corporation
CEL-SCI Corporation is developing products that empower immune defenses. Its lead product is Multikine. 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 LEAPS 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. 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 for the year ended September 30, 2010. 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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