SGX Pharmaceuticals, Inc.
(Nasdaq: SGXP) announced that it has submitted an investigational new
drug (IND) application to the U.S. Food and Drug Administration for SGX523.
This compound is an internally developed, orally-bioavailable, small
molecule inhibitor of the cMET receptor tyrosine kinase. The Company
expects to begin Phase I clinical trials of SGX523 for solid tumor cancer
patients in early 2008.
"This IND submission is one quarter earlier than originally anticipated
and represents a significant achievement for our organization," said Mike
Grey, President and Chief Executive Officer of SGX Pharmaceuticals.
"Submission of the SGX523 IND package less than ten months after the
compound's nomination as a formal development candidate speaks highly of
the effectiveness of our research and development capabilities. We look
forward to capitalizing on this positive momentum and initiating clinical
studies in solid tumor cancer patients following FDA review of our
submission."
About SGX523 and cMET
SGX523 has shown significant selectivity for the cMET receptor tyrosine
kinase over more than 200 protein kinases and has demonstrated both potent
in vitro blockade of the activity of this cancer target and in vivo
activity against human cancer cells that depend on cMET for their
uncontrolled growth and proliferation. The cMET receptor tyrosine kinase
has been implicated in a wide range of cancers, including both solid and
blood tumors. cMET has been extensively studied in both the laboratory
environment and the clinic, with increasing data suggesting that
uncontrolled stimulation of cMET plays a key role in a variety of effects
associated with cancer, including cellular growth, increased cell movement
and invasion, and an increased ability of cancer cells to metastasize.
Other observations have implicated cMET in increased angiogenesis. Studies
of tumors in humans have associated cMET with more aggressive forms of
cancer, such as lung and renal cancer, and activating cMET mutations have
been observed in a wide range of other cancer types including colon,
prostate, and gastric cancers.
About SGX Pharmaceuticals
SGX Pharmaceuticals is a biotechnology company focused on the
discovery, development and commercialization of innovative cancer
therapeutics. The SGX oncology pipeline includes drug candidates from its
FAST(TM) drug discovery platform, such as next generation BCR-ABL
inhibitors being developed by SGX and in partnership with Novartis and cMET
tyrosine kinase inhibitors, including SGX523, and JAK2 inhibitors. More
information on the pipeline and drug discovery platform can be found at
sgxpharma and in the Company's various filings with the
Securities and Exchange Commission.
Forward-looking Statements
Statements in this press release that are not strictly historical in
nature are forward-looking statements. These statements include, but are
not limited to, the potential of SGX523 as a treatment for certain cancers,
the outcome of FDA review of the SGX523 IND submission, timing of
commencement of clinical studies and the ability of the company to
discover, develop and commercialize cancer therapeutics. These statements
are only predictions based on current information and expectations and
involve a number of risks and uncertainties. Actual events or results may
differ materially from those projected in any of such statements due to
various factors, including the risks and uncertainties inherent in drug
discovery, development and commercialization. The results of early
preclinical studies or clinical trials may not be predictive of future
results, and the Company cannot provide any assurances that any of its
compounds or development candidates will have favorable results in
preclinical studies or future clinical trials or that the FDA will approve
the commencement of clinical trials. For a discussion of these and other
factors, please refer to the risk factors described in the Company's annual
report on Form 10-K for the year ended December 31, 2006, the Company's
quarterly report on Form 10-Q for the three and nine months ended September
30, 2007, as well as other filings with the Securities and Exchange
Commission. You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof. This
caution is made under the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. All forward-looking statements are qualified
in their entirety by this cautionary statement and SGX undertakes no
obligation to revise or update this press release to reflect events or
circumstances after the date hereof.
SGX Pharmaceuticals, Inc.
sgxpharma