CEL-SCI says goals include starting Multikine phase 3 clinical trial, expanding indications

By Jennifer Lanning Drey

Portland, Ore., Nov. 14 - CEL-SCI Corp.'s near-term goals include beginning a phase 3 clinical trial of its lead product candidate Multikine in head and neck cancer patients and expanding the compound's possible indications, chief executive officer Geert Kersten said during the Life Sciences On-line Forum on Tuesday.

Canadian regulatory officials have cleared the company's plans for a phase 3 trial of the drug in head and neck cancer, and the study design is pending approval from the Food and Drug Administration.

"The drug has been shown to be very safe, the drug has shown great promise. It now needs to be tested in a controlled study," Kersten said Tuesday.

Multikine is a patented mixture of naturally derived cytokines that replicate a body's healthy immune response.

CEL-SCI's worldwide phase 3 clinical trial of the drug will involve 500 patients, half of whom will be given Multikine prior to receiving the current standard of care, which is surgery followed by radiation alone or with chemotherapy.

Endpoints of the study are local regional control and overall survival.

As Multikine enters into phase 3 clinical trials, Kersten said CEL-SCI plans to further explore previous data demonstrating additional benefits derived from Multikine, including evidence that the drug can significantly reduce cholesterol levels.

In addition, a separately conducted previous study performed with HIV-infected women with human papilloma virus showed that Multikine killed 75% of the human papilloma virus infection, Kersten said.

CEL-SCI also plans to study Multikine in primary breast cancer - which has the same progression as head and neck cancer - malignant melanoma, cervical cancer and the hepatitis B and hepatitis C viruses, he said.

CEL-SCI's additional near-term goals include advancing CEL-1000, its patented peptide that activates the innate immune system, into clinical trials.

The company believes the compound will be a good adjuvant to be used with vaccines and has already filed a patent for CEL-1000 for the prevention/treatment of avian bird flu and/or as an adjuvant to be included in a bird flu vaccine.

CEL-SCI is developing new immune system-based treatments for cancer and infectious diseases and has operations in Vienna, Va., and Baltimore, Md.

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