FDA Okays Two Multikine Studies

Cel-Sci Corp has been granted approval by the US Food and Drug Administration to start two trials of its investigational immunotherapeutic, Multikine, in patients with prostate cancer and head and neck cancer.

The prostate study will be conducted at Jefferson Hospital in Philadelphia, Pennsylvania, and will involve up to 15 prostate cancer patients who have failed on hormonal therapy. The head and neck cancer study will be conducted at sites in the USA and Canada, and will involve up to 30 patients who have failed on conventional therapies.

Cel-Sci has been evaluating US sites for the study. The Canadian regulatory authorities already cleared the head and neck cancer trial, and the first study site, in Montreal, is currently screening patients. Multikine is a naturally-derived combination of human immune system modulators, containing interleukin-2 and other cytokines.