SAN DIEGO, Jan. 16 /PRNewswire-FirstCall/ -- SGX Pharmaceuticals, Inc. (Nasdaq: SGXP) today announced that it has opened enrollment in two Phase I studies, with the first patient being treated on January 14, 2008. The Phase I studies are designed to evaluate the safety, tolerability and pharmacokinetic profile of SGX523, an internally developed, orally-bioavailable, small molecule inhibitor of the cMET receptor tyrosine kinase.
The Phase I clinical trials are open-label, dose escalation studies of SGX523 administered orally to patients with advanced cancer who have either failed standard therapy or for whom no standard therapy exists. The studies are designed to explore two dosing regimens in parallel. The continuous dosing trial will have continuous uninterrupted twice daily dosing with patients being evaluated every 28 days for continuation of treatment. The intermittent dosing schedule will implement twice daily dosing on a 14 days on/7 days off therapy schedule, cycling every 21 days. In both protocols, patients may continue on therapy for up to 12 months as determined by the patient's response and tolerance to SGX523.
"SGX523 is our first internally discovered clinical candidate. We are excited to begin studying SGX523 in humans and to achieve the first of our 2008 clinical development goals," said Mike Grey, President and Chief Executive Officer of SGX Pharmaceuticals. "With two separate dosing schedules, we believe that we will be able to collect important data that could serve as a basis for future clinical development activities and position us to capitalize on the evolving cMET opportunity."
About SGX523 and cMET
SGX523 has shown exceptional selectivity for the cMET receptor tyrosine kinase over more than 200 protein kinases and has demonstrated both potent in vitro blockage of the activity of this cancer target and in vivo activity against various types of 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 the laboratory environment and, to a lesser extent, in 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. cMET activation has been observed in a wide range of other cancer types including breast, colon, prostate, pancreatic 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 potential outcome of Phase I clinical studies of SGX523, the role of cMET in cancer, statements regarding bringing compounds into the clinic and the ability 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. 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.
SOURCE SGX Pharmaceuticals, Inc.