First approval of Melacine in Canada

5 November 1999

Corixa Corp's therapeutic vaccine for malignant melanoma, Melacine, hasbeen approved by Canada's Health Protection Branch. The vaccine, originally developed by Ribi ImmunoChem (acquired by Corixa in October), will be launched "as soon as is practicable" by Schering Canada, a wholly-owned subsidiary of Schering-Plough, which has worldwide marketing rights to the product under an exclusive licensing agreement.

Melacine consists of lysed cells from two human melanoma cell lines combined with Corixa's proprietary Detox adjuvant. Canadian approval was granted based upon results of a Phase III trial which showed that Melacine provided superior quality of life during active therapy for Stage IV melanoma compared to a four-drug chemotherapy control, with comparable efficacy.

Corixa noted that it is awaiting the results of additional Phase III evaluations before deciding upon a regulatory strategy in the USA and Europe. Ongoing trials include a study of S-P's Intron A (interferon alfa-2b) with or without Melacine in stage IV melanoma patients, and a study evaluating vaccination versus observation only in Stage II patients post-surgery. Results of these studies should be available in spring 2000.

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