FDA Approval Sought for Trial of Canvaxin™ Vaccine for Advanced Colon Cancer

CancerVax Corporation is seeking U.S. Food and Drug Administration approval to initiate a Phase 2/3 clinical trial of the Canvaxin™ cancer vaccine as a treatment for metastatic colon cancer.

The multi-center study will assess overall survival and the safety and effectiveness of the vaccine versus standard care of patients with Stage IV colon cancer who have had surgical removal of the primary tumor and any known metastases.

The Canvaxin vaccine is a whole cell vaccine that expresses at least 20 known tumor-associated antigens, fourteen of which are specifically cross-reactive with colon cancer. The cancer vaccine harnesses the body's immune system to produce both cellular and antibody response to the cancer.

In previous studies the Canvaxin vaccine induced specific immune responses that correlated with survival in patients suffering from advanced colorectal cancer.

"There is a significant need for more effective and safer therapeutics for the treatment of advanced metastatic colon cancer, which is one of the deadliest forms of cancer in the U.S. and the world," said CancerVax President David F. Hale. "With the start of this pivotal trial, following FDA review of the protocol, Canvaxin will be in late stage, multi-center clinical trials for two cancers for which there are currently no adequate therapies -- advanced metastatic colon cancer and metastatic melanoma."

Other Sources: CancerVax