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2001 AUG 22 - (NewsRx.com & NewsRx.net) --
CancerVax Corporation announced its intent to prepare a New Drug Submission (NDS) to seek marketing approval in Canada for Canvaxin(TM), a therapeutic vaccine for the treatment of advanced-stage melanoma.
The decision is based on discussions with representatives from the Biologics and Genetic Therapies Directorate of Health Canada's Health Products and Food Branch (Directorate) following the presentation of a summary of Phase II trial results. CancerVax anticipates completing the submission by the third quarter of 2002.
CancerVax presented a summary of the extensive Phase II data on the use of its therapeutic vaccine in patients with advanced-stage melanoma compared to historical control patients who did not receive the therapeutic vaccine. Published results in patients with advanced-stage melanoma have shown the potential for the Canvaxin vaccine to significantly increase both five-year survival rates and median overall survival when compared with historical controls.
"Based on the positive response of the Directorate to the summary of the Phase II data on the Canvaxin vaccine, we now intend to allocate the necessary resources for preparing ...