Chiron (NASDAQ:CHIR)
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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.