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| |  Proleukin Approved In Canada For Metastatic Melanoma EMERYVILLE, CA -- Jan. 8, 1999 -- Canada’s Health Protection Branch has issued a notice of compliance to Chiron Corp.’s Proleukin(R) (aldesleukin) for metastatic melanoma. Proleukin is currently approved in the United States, Canada and Europe for the treatment of patients with metastatic renal cell carcinoma. It is approved also in the United States for malignant metastatic melanoma. Proleukin is currently available to patients in 47 countries world-wide. In clinical trials of Proleukin, 16 percent (43/270) of patients responded to the drug and approximately half of these patients (22/43) remain alive over four years after treatment. In an analysis of the data, Proleukin produced a complete response in six percent (17/270) of patients. A complete response was defined as the total disappearance of tumours for two consecutive observations at least 28 days apart. Approximately 60 percent of the 17 patients who achieved a complete response have remained in remission for greater than five years without further treatment. The median duration of complete response has not yet been observed, but is at least 40 months. By comparison, the median duration of partial response was 5.9 months. These data indicate that durable responses can be achieved in some metastatic melanoma patients treated with Proleukin. Proleukin can result in a number of adverse events including capillary leak syndrome (CLS) and flu-like symptoms. Nearly all patients experienced serious toxicities. These included low blood pressure, decreased kidney and lung function, respiratory distress, cardiac abnormalities, changes in mental status and edema (fluid retention). In a majority of cases these adverse events were fully reversible after cessation of therapy. Melanoma, a type of skin cancer whose overall incidence is increasing faster than that of any other cancer, occurs when certain skin cells called melanocytes (pigment-producing cells located in the top layer of the skin) become malignant, or cancerous. Melanoma is the most frequent cancer occurring in women between the ages of 25 and 29 years and, after breast cancer, is the second most frequent cancer in women 30 to 34 years of age. Metastatic melanoma is the most advanced form of the disease and occurs as a result of the cancer spreading rapidly from the initial site to more distant parts of the body where it continues to grow and destroy tissue. Unlike traditional cancer therapies, Proleukin does not attack cancer cells themselves. Instead, it enhances the body's immune defences by mimicking the way natural IL-2 activates the immune system and stimulates the growth and activity of cancer-killing cells. Although Proleukin's exact mechanism of action is unknown, it is believed to help the body recognise cancer cells as foreign, thus boosting the body's immune response to them. Related Links: Chiron Corp.
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