CHIR Chiron (MM)

Chiron Corporation (NASDAQ:CHIR) today announced the initiation of a Phase 1 clinical trial of CHIR-265, a selective Raf kinase inhibitor, in patients with melanoma. "We are pleased to move forward with clinical study of this exciting new compound," said Stephen Dilly, chief medical officer, Chiron BioPharmaceuticals. "Malignant melanoma is a promising indication for CHIR-265, given the high percentage of Raf mutations associated with the disease and the need for effective new treatments." The single-agent, open-label Phase 1 study of CHIR-265 is designed to evaluate the safety, dose tolerability and pharmacokinetic profile of CHIR-265 in patients with melanoma. A translational medicine approach will be used to monitor biomarkers in order to evaluate the biological activity and define the optimal dose. The study is expected to enroll up to 60 patients at three leading cancer centers in the United States. About CHIR-265 CHIR-265 is a novel, orally bioavailable small molecule inhibitor of the Raf kinases, including mutant B-Raf (V600E), that also inhibits VEGFR-2. Preclinical data suggest that CHIR-265 has both direct anti-proliferative/pro-apoptotic activity on tumor cells as well as anti-angiogenic activity that targets the tumor blood supply. Based on these data, CHIR-265 may have broad-based efficacy in human cancer, with selectivity for cancers with a high frequency of B-Raf mutations such as malignant melanoma. CHIR-265 is an investigational drug candidate and has not been approved by the U.S. Food and Drug Administration. About Melanoma Melanoma is a type of skin cancer that begins in pigment producing skin cells called melanocytes. Melanoma is the sixth most common cancer in the United States, and incidence rates are increasing faster than for any other cancer. According to the American Cancer Society, the incidence of melanoma has more than doubled since 1973. In 2005, melanoma was newly diagnosed in more than 59,000 people in the United States and resulted in approximately 7,800 deaths. When diagnosed early, melanoma is highly curable through surgery; however, in patients with advanced disease, the prognosis is generally poor, as melanoma is highly resistant to most currently available therapies. About Chiron Chiron delivers innovative and valuable products to protect human health by advancing pioneering science across the landscape of biotechnology. The company works to deliver on the limitless promise of science and make a positive difference in people's lives. For more information about Chiron, please visit www.chiron.com. This news release contains forward-looking statements, including statements regarding development of CHIR-265, success of clinical trials involving CHIR-265, indications for CHIR-265 and patient enrollment, that involve risks and uncertainties and are subject to change. Forward-looking statements often address our expected future performance and often contain words such as "expects," "anticipates," "intends," "plans," "believes," "seeks" or "will." A discussion of the company's operations and financial condition, including factors that may affect its business and future prospects that could cause actual results and developments to differ materially from those expressed or implied by forward-looking statements, is contained in documents the company has filed with the SEC, including the Form 10-K for the year ended December 31, 2005, and will be contained in all subsequent periodic filings made with the SEC. These documents identify important factors that could cause the company's actual performance to differ from current expectations, including, among others, the outcome of clinical trials, regulatory review and approvals, manufacturing capabilities, intellectual property protections and defenses, stock-price and interest-rate volatility, and marketing effectiveness. In addition, the company may engage in business opportunities, the successful completion of which is subject to certain risks, including approval by Novartis AG, other stockholders and the integration of operations. Chiron does not undertake an obligation to update the forward-looking information the company is giving today.