CancerVax Announces Published Data Indicate Treatment With CANVAXIN Vaccine Increased Survival of Stage III Melanoma Patients.

Business Editors & Health/Medical Writers

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CARLSBAD, Calif.--(BUSINESS WIRE)--Dec. 9, 2002

CancerVax Corporation announced today that data published in the Annals of Surgery (Vol. 236, No. 4) indicated that treatment with its experimental CANVAXIN(TM) therapeutic cancer vaccine, following surgical removal of all clinically detectable melanoma, increased overall survival in patients with Stage III melanoma. The data involved retrospective analyses of patients with Stage III melanoma.

Analysis comparing treated group vs. non-treated group

The first analysis evaluated 2,602 patients who underwent complete lymphadenectomy (surgical removal of lymph nodes) for the treatment of Stage III melanoma. Of these patients, 935 received post-surgical treatment with the CANVAXIN(TM) vaccine (treated group) and 1,667 received other or no adjuvant therapy (non-treated group). Median overall survival and five-year overall survival were significantly higher in patients who received the CANVAXIN(TM) vaccine (56.4 vs. 31.9 months and 49% vs. 37%, respectively; p=0.0001).

Analysis using matched-pair data

In a matched-pair analysis conducted to reduce the effect of possible selection bias for those patients receiving post-operative CANVAXIN(TM) therapy, 739 patients treated with the CANVAXIN(TM) vaccine were matched with 739 non-treated patients based on six prognostic factors known to affect the survival of patients with Stage III melanoma as identified by the AJCC Melanoma Staging Committee: number of metastatic nodes, nodal size (palpable or non-palpable), ulceration, stage of primary tumor, sex and age. In this matched-pair analysis, median overall survival and five-year overall survival were also significantly higher in patients who received the CANVAXIN(TM) vaccine (55.3 vs. 31.6 months and 49% vs. 37%, respectively, p=0.0001).

Data regarding these studies were published in an article entitled, "Prolonged Survival of Patients Receiving Active Immunotherapy With CANVAXIN(TM) Therapeutic Polyvalent Vaccine After Complete Resection of Melanoma Metastatic to Regional Lymph Nodes," D.L. Morton, et.al. Patients in these analyses, which were performed at the John Wayne Cancer Institute (JWCI), were identified using the Institute's database of more than 10,000 melanoma patients. Patients defined as "treated" had surgical resection of clinically detectable melanoma, followed by administration of the vaccine in one of several protocols at the JWCI. Treatment for patients defined as "non-treated" included surgical resection of all clinically detectable melanoma and other adjuvant therapy including chemotherapy, biotherapy, bacillus Calmette-Guerin (BCG), or observation.

The CANVAXIN(TM) vaccine is currently being evaluated in two international, double-blind, placebo-controlled, Phase 3 clinical trials for the treatment of patients with Stage III and Stage IV melanoma who have had all clinically detectable melanoma surgically removed. These two trials are currently on partial clinical hold for the enrollment of new patients while CancerVax develops certain information requested by the U.S. Food and Drug Administration (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.

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 Company believes that there are numerous advantages to the allogeneic approach, including high immunogenicity, polyvalence, no requirement for resection of a patient's tumor tissue to produce the vaccine, and a standardized manufacturing procedure. The CANVAXIN(TM) vaccine has been administered to more than 2,600 cancer patients in clinical trials and has been shown 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 novel therapeutic cancer vaccines, angiogenesis inhibitors and monoclonal antibodies 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 pre-clinical 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.

Comments made by the physicians in the "Discussion" section following the article discussed in this news release reflect the opinions of the individuals quoted therein and not those of CancerVax Corporation. CancerVax Corporation specifically disclaims any statements made in the "Discussion" section of this article that purport to address the safety or efficacy of the experimental Canvaxin(TM) therapeutic cancer vaccine, including any toxicity associated therewith, as well as any comments regarding the status of discussions with regulatory agencies regarding requirements for regulatory approval of the vaccine.

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