GammaCan to file IND for VitiGam for treatment of skin cancer

By Lisa Kerner

Erie, Pa., March 22 - GammaCan International Inc. said it met with the Food and Drug Administration on March 1 to discuss requirements for the filing of an Investigational New Drug application for VitiGam, the company's second-generation treatment for metastatic melanoma (skin cancer).

The company held the meeting based on its evidence that plasma from donors with vitiligo, a benign condition affecting skin pigmentation, has anti-melanoma properties, according to a news release.

"The meeting with the FDA is an important step toward getting VitiGam into the drug approval process," said Jacob Nusbacher, M.D., director of medical and scientific affairs, in the release.

"GammaCan is very pleased with the meeting and received valuable input. We will be building on these discussions and plan to go forward with the development of VitiGam in order to seek FDA approval to initiate human clinical trials."

Melanoma is a skin cancer caused by the uncontrolled growth of melanocytes affecting about 55,000 new patients in the United States each year.

Vitiligo, present in 40 million to 50 million people worldwide, is a pigmentation disorder in which melanocytes in the skin, the mucous membranes and the retina are destroyed.

GammaCan, located in Givat Shmuel, Israel, commercializes anticancer immunotherapy.

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