CEL-SCI Corporation announces that its investigational immunotherapy drug Multikine has been shown to lower cholesterol in clinical studies involving 120 head & neck cancer patients.

In light of the liver toxicity seen with the widely prescribed cholesterol lowering drugs called statins (e.g. Lipitor, Zorcor, Mevacor), it is important to note that 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, the company said in a release.

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.

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.

Geert Kersten, CEO of CEL-SCI said, "The focus of CEL-SCI has been on oncology, but we have always believed that Multikine has many other potential applications. While the current clinical trials studied and evaluated multiple doses and different treatment regimens for Multikine in head & neck cancer, it was serendipitous that the studies showed highly statistically significant results for the lowering of the cholesterol level following Multikine treatment. We are very excited about these results and look forward to the presentation/publication of these new data."

Multikine is a patented immunotherapeutic agent consisting of a mixture of naturally occurring cytokines including interleukins, interferons, chemokines and colony-stimulating factors. Multikine has completed several phase II clinical trials. Phase III clinical trials for head & neck cancer are in the planning stage, the release added.