CancerVax Granted Fast Track Designation for CANVAXIN Vaccine for Metastatic Melanoma.

Business Editors & Health/Medical Writers

BIOWIRE2K

CARLSBAD, Calif.--(BUSINESS WIRE)--Jan. 27, 2003

CancerVax Corporation announced today that the U.S. Food and Drug Administration (FDA) has granted the Company's therapeutic cancer vaccine, CANVAXIN(TM), Fast Track designation for the post-surgical treatment of patients with metastatic melanoma. Fast Track designation is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs for those conditions.

The CANVAXIN(TM) vaccine is being evaluated in two international, randomized, double-blind, placebo-controlled, Phase 3 clinical trials for the post-surgical treatment of patients with Stage III or Stage IV melanoma. These two trials are currently on partial clinical hold for the enrollment of new patients while CancerVax develops certain information requested by the FDA related to the production, characterization and testing of the CANVAXIN(TM) vaccine. The partial clinical hold on new patient enrollment is not the result of any clinical practice or safety concerns related to the CANVAXIN(TM) vaccine. The FDA stated that those patients in the two Phase 3 clinical trials who are already receiving the CANVAXIN(TM) vaccine are allowed to continue to receive the CANVAXIN(TM) vaccine. CancerVax continues to work diligently to complete the development of the information requested by FDA.

"We are very pleased with the decision of the FDA to grant Fast Track designation for CANVAXIN(TM) for the treatment of metastatic melanoma," said David F. Hale, President and CEO of CancerVax. "Fast Track status allows us the opportunity for increased interactions with FDA staff, and the potential for priority review of a license application should the CANVAXIN(TM) vaccine prove to be safe and effective in its clinical trials."

About Melanoma

Melanoma, the deadliest form of skin cancer, is diagnosed in approximately 132,000 people worldwide each year (2000 data) and is increasing at a rate of 3-5% per year. While melanoma is 85-90% curable if identified and treated in its earliest stages, melanoma that has metastasized (spread to other parts of the body) is deadly. Even after surgical removal, the five-year survival rate for metastatic melanoma is only 20-50%. According to the American Cancer Society, the lifetime risk of malignant melanoma in the U.S. has risen from 1/1,500 people in 1935 to 1/74 people in 2000, with a forecast of 1/50 people by 2005.

About CANVAXIN(TM)

CancerVax's patented, core technology is based on the development of allogeneic whole-cell vaccines, which express multiple antigens that are associated with melanoma and other solid tumors. The experimental CANVAXIN(TM) therapeutic vaccine is composed of three allogeneic tumor cell lines that together express over 30 tumor- or melanoma-associated antigens. Although the vaccine's mechanism of action has not been established, research indicates that the antigens expressed in the CANVAXIN(TM) vaccine stimulate the body's own immune system to produce cancer-fighting T cells and antibodies. The polyvalent (multiple antigen) nature of the vaccine confers a high probability of an antigenic match with individual patients with melanoma and other solid tumors. The CANVAXIN(TM) vaccine has been administered to more than 2,600 cancer patients in clinical trials and appears to be well-tolerated.

About CancerVax Corporation (www.cancervax.com)

CancerVax Corporation is a privately held biotechnology company focused on the research, development and commercialization of biological products for the treatment and control of cancer. The Company's lead product candidate, CANVAXIN(TM), is a therapeutic cancer vaccine currently being evaluated in late-stage clinical trials for the treatment of advanced-stage melanoma. CancerVax also plans to evaluate the CANVAXIN(TM) vaccine in the treatment of advanced-stage colon cancer. The Company has additional product candidates in preclinical development for the treatment of solid tumor cancers, including several monoclonal antibodies that appear to inhibit angiogenesis, the blood vessel development that is necessary for tumor growth. CancerVax maintains its corporate headquarters in Carlsbad, California, and its biologics manufacturing facility in Los Angeles, California.

CancerVax cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by CancerVax that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in CancerVax's business including, without limitation, statements about: the progress and timing of its clinical trials; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing its products; unexpected adverse side effects or inadequate therapeutic efficacy of its products that could delay or prevent product development or commercialization, or that could result in recalls or product liability claims; the scope and validity of patent protection for its products; competition from other pharmaceutical or biotechnology companies; and its ability to obtain additional financing to support its operations. All forward-looking statements are qualified in their entirety by this cautionary statement and CancerVax undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.

CancerVax(R) and CANVAXIN(TM) are trademarks of CancerVax Corporation.