Chiron Announces Initiation of Phase 1 Trial for CHIR-265 In Melanoma; Clinical Testing of Novel Oncology Compound Begins in Pa
11 April 2006 - 10:00PM
Business Wire
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.
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