The company anti-cancer immunotherapy, VitiGam, is designed to treat melanoma.
GammaCan International Inc. (Bulletin Board:GCAN.OB) has obtained orphan drug designation from the US Food and Drug Administration (FDA) for its anti-cancer immunotherapy, VitiGam. Orphan Drug designation entitles GammaCan to exclusive marketing rights in the US for VitiGam for up to seven years should the company be the first to receive marketing approval for this therapeutic drug product. The company plans to apply to the FDA for a Phase I/II clinical trial by year-end, and initiate clinical testing of the drug in early 2008.
The Orphan Drug Act provides for granting special status to a product to treat a rare disease or condition upon request of a sponsor. The purpose is to encourage the development of treatments for small markets when the investment in drug development is high to point of being uneconomical for the company under ordinary circumstances. Subject to certain criteria, the developer of an orphan drug is eligible for tax credit and marketing incentives.
VitiGam is an anti-cancer immunotherapy for the treatment of Stage III and Stage IV melanoma. It is manufactured from the plasma of donors with Vitiligo, a benign skin condition affecting up to 2% of the general population. Vitiligo attacks the skin pigments, causing white skin blemishes, but has no other effects. An injection of an immunotherapy into these cells should help cancer patients.
Published by Globes [online], Israel business news - www.globes.co.il - on August 8, 2007
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