Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.GammaCan International has reported that its lead anticancer immunotherapy, VitiGam, has received orphan drug designation by the FDA for the treatment of stage IIB to stage IV metastatic melanoma.
Subscribe to our email newsletter
GammaCan anticipates filing an IND with the FDA for a Phase I/II clinical trial by year-end, and initiating clinical testing of VitiGam in early 2008.
Orphan drug designation entitles GammaCan to exclusive marketing rights in the US for VitiGam for up to seven years should it be the first company to receive marketing approval for this therapeutic drug product.
Under the orphan drug act (ODA), the FDA will not accept or approve other applications from other sponsors to market an identical medicinal product for the same therapeutic indication for the seven-year period. In addition, the designation allows GammaCan to apply for a waiver from the FDA of certain filing and user fees required by the prescription drug user fee act.
Commenting on the orphan drug designation, Steven Katz, chairman of the board and president of GammaCan, said: “This will afford GammaCan additional protection in marketing VitiGam once we are granted approval. This designation highlights the acute need for new therapies to treat metastatic melanoma.”