SGX Pharmaceuticals Submits Investigational New Drug Application for SGX523, a Highly Potent, Selective, Orally Bioavailable cME
December 03 2007 - 6:00AM
PR Newswire (US)
SAN DIEGO, Dec. 3 /PRNewswire-FirstCall/ -- SGX Pharmaceuticals,
Inc. (NASDAQ:SGXP) today 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
http://www.sgxpharma.com/ 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. DATASOURCE: SGX Pharmaceuticals, Inc. CONTACT:
Todd Myers, Chief Financial Officer of SGX Pharmaceuticals, Inc.,
+1-858-558-4850; or Media & Investor Relations, Jason Spark of
Porter Novelli Life Sciences, +1-619-849-6005, for SGX
Pharmaceuticals, Inc. Web site: http://www.sgxpharma.com/
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