Update on CancerVax's melanoma trials

CancerVax has completed the planned enrollment of 1,118 patients into its Phase III clinical trial of Canvaxin for the treatment of patients with stage III melanoma.

The international, randomised, double-blinded, placebo-controlled trial is designed to evaluate the ability of Canvaxin, a specific active immunotherapy or therapeutic cancer vaccine, to extend the survival of patients with stage III melanoma following surgical resection of their tumours.

With enrollment of new patients in this clinical trial complete, CancerVax will focus on completing the treatment and follow-up of patients already enrolled in this study, as well as continue to enroll new patients in its ongoing Phase III clinical trial of Canvaxin for the treatment of patients with stage IV melanoma.

'The completion of enrollment in this Phase III clinical trial is an important milestone in our efforts to complete the clinical development of, seek regulatory approval for and, if we are successful, make Canvaxin available to treat patients with this deadly disease,' said David Hale, president and ceo of CancerVax. 'Reaching this milestone is a tribute to the dedication of the CancerVax team and the many physicians and patients around the world who are participating in this clinical trial.'

Canvaxin is one of the most widely studied specific active immunotherapies for the treatment of cancer. More than 1,500 patients have been enrolled in CancerVax's two Phase III clinical trials of the treatment in patients with advanced-stage melanoma at over 80 clinical trial sites around the world, and more than 2,600 patients with melanoma were treated with it in Phase I and II clinical trials. The two ongoing Phase III clinical trials, in addition to measuring a primary endpoint of overall survival, will also evaluate whether Canvaxin will prolong disease-free survival and disease-free interval compared with placebo.

During the first quarter of 2005, CancerVax anticipates that the independent data safety monitoring board (DSMB) with responsibility for oversight of the Phase III clinical trial for stage III melanoma will complete its review of the third and final interim analysis of data from the clinical trial. The final analysis of data from this clinical trial will occur after 392 deaths, which the Company anticipates will occur in the fourth quarter of 2005 or the first quarter of 2006.

CancerVax will concentrate on completing the enrollment of patients in the company's Phase III clinical trial of Canvaxin for patients with stage IV melanoma at 70 clinical trial sites around the world. As of September 21, 424 patients out of a planned 670 have been enrolled in this clinical trial. Based on a re-assessment of the rate of deaths, CancerVax now believes that the DSMB will perform its second interim analysis of data from this clinical trial during the first quarter of 2005.

Treatment with Canvaxin in Phase I and II clinical trials has been well tolerated and retrospective, matched pair analyses have shown a significant improvement in median overall survival of patients with stage III and stage IV melanoma who received Canvaxin in one of the Phase II clinical trials when compared with historical control patients who did not receive Canvaxin.

'While patients who are diagnosed early and receive appropriate surgical treatment for Stage I and II melanoma have high survival rates, at least 50% of patients with stage III melanoma will recur after surgery and only 7-19% of patients diagnosed with Stage IV melanoma survive five years,' said Dr Merrick Ross, professor of Surgical Oncology at the University of Texas.

'The Canvaxin clinical trials for stage III and stage IV melanoma will evaluate a large patient population. I am excited to be involved in exploring ways to utilise the immune system to fight this deadly disease.' Dr. Ross is a paid consultant to CancerVax Corporation.

'Melanoma is one of the fastest growing types of cancers. According to the American Cancer Society, an estimated 55,000 new cases will be diagnosed in the United States in 2004, double the number from 30 years ago,' said Mary Loh, executive director of the American Melanoma Foundation.

'Prevention and early detection are the best defences against early-stage melanoma, but we desperately need new treatment options for patients suffering with advanced stages of this disease.'

About melanoma

According to the American Cancer Society, melanoma is the deadliest type of skin cancer and is the sixth most commonly diagnosed cancer in the United States. As reported by the World Health Organisation, the worldwide incidence, or number of newly diagnosed cases, of melanoma in 2000 was 132,600, with 37,000 people dying of the disease. The American Cancer Society estimates that in the United States, approximately 55,000 people will be diagnosed with melanoma and 7,900 will die as a result of the disease in 2004. Furthermore, according to the National Cancer Institute, since 1997 the incidence of new melanoma cases in the United States has increased at an average rate of more than 5% per year, one of the highest growth rates for any type of cancer. In 2000, over 510,000 patients in the United States were alive who had been diagnosed with melanoma.

About Canvaxin

Canvaxin, one of a new class of products being developed in the area of specific active immunotherapy, is based on a proprietary technology that may potentially be applied to treat a number of cancers. Canvaxin is polyvalent, expressing at least 38 tumour-associated antigens; allogeneic, which may result in lower manufacturing costs than patient-specific immunotherapies; and is made of whole cells, which may stimulate a strong immune response. Canvaxin has both orphan drug and fast track designations from the FDA for the treatment of invasive and metastatic melanoma, respectively, and is currently being studied in two international Phase III clinical trials for the treatment of patients with Stage III and Stage IV melanoma.