SGX Pharmaceuticals Submits Investigational New Drug Application For SGX523, A Highly Potent, Selective, Orally Bioavailable CMET Inhibitor

Main Category: Cancer / Oncology
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 04 Dec 2007 - 0:00 PST

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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 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.

SGX Pharmaceuticals, Inc.
http://www.sgxpharma.com