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.
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.