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/ [1] and in the Company's various filings with the Securities and Exchange Commission.
Links:
[1] http://www.sgxpharma.com/