Thursday May 13, 1999

Company Press Release

SOURCE: John Wayne Cancer Institute

Three Out of Four Melanoma Patients Treated With Novel Vaccine Survived at Least Three Years, Study Finds

Researchers at John Wayne Cancer Institute Publish Findings of CancerVax Vaccine in Current Issue of Cancer

Seventeen Percent Overall Remission Rate and Minimal Side Effects Reported

SANTA MONICA, Calif., May 13 /PRNewswire/ -- A new study has found that 77 percent of patients suffering from the deadliest form of skin cancer survived for three years after receiving a novel vaccine developed by melanoma researchers at the John Wayne Cancer Institute at Saint John's Health Center, Santa Monica, California. The study is published in the current issue of Cancer (May 15).

Melanoma is the most serious form of skin cancer. The American Cancer Society estimates that 44,200 people in the U.S. will be diagnosed with melanoma and 7,300 will die from the disease this year. The number of melanoma cases diagnosed in the U.S. has increased nearly four percent each year since 1973.

Of 54 patients treated with the polyvalent melanoma cell vaccine called CancerVax, nine (17 percent) experienced partial or complete disappearance of melanoma tumors that had spread from the tumor's initial site on the skin.

Four of these patients remain disease free or have shown no evidence of melanoma for a follow-up period of 22 months to over nine years. Of the 45 patients who did not have a clinical response to primary CancerVax, 23 patients were rendered disease free by various additional therapies, including a combination of CancerVax and surgery, with a median disease-free interval of 14 months.

Researchers say CancerVax contains more than 20 potent antigens that can induce an immune system response against melanoma tumor cells. ``Our results indicate that CancerVax may generate an immune response strong enough to halt the progression of the disease,'' said the study's senior author, Donald L. Morton, M.D., medical director of the John Wayne Cancer Institute.

Eddy C. Hsueh, M.D., co-author of the study, added: ``The potential therapeutic benefit of CancerVax coupled with its lack of significant side effects makes the vaccine will worth additional investigation.''

Their findings suggest that the vaccine may be most useful in conjunction with other drug therapies, chemotherapy, radiation, and surgical removal of melanoma lesions.

The 54 patients in the study were treated and evaluated at the John Wayne Cancer Institute between July 1, 1985 and January 13, 1997. Each patient in the study received CancerVax in a series of injections administered over a five-year period. The clinical response to treatment was assessed objectively by measuring changes in the size of melanoma lesions. Of the nine responding patients, two had more than a 50 percent decrease in lesion size for one to three months; the remaining seven patients had a 100 percent decrease in lesion size for one month to more than 114 months.

Of all 54 patients, 29 are still alive and 17 are free of the disease. Among the nine with a partial or complete response to CancerVax, the median survival was more than 53 months. The 77 percent rate of three-year survival for responders compares favorably with five-year survival rates of 33 percent and 18 percent reported in two previous studies of patients with the same stage of melanoma.

Importantly, researchers said that treatment with CancerVax produced few and minimal side effects. Skin irritation at the injection site, fatigue and mild anemia (too few red blood cells) were the most common side effects reported in this study.

SOURCE: John Wayne Cancer Institute