SAN DIEGO, June 30 /PRNewswire-FirstCall/ -- SGX Pharmaceuticals (Nasdaq: SGXP) today announced that it has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration for SGX393. This compound is an internally developed, selective, orally-bioavailable small molecule for the treatment of relapsed and refractory chronic myelogenous leukemia (CML).
The standard of care for CML is Gleevec(R). Although Gleevec is a highly effective front-line therapy for CML, there are patients who relapse while on Gleevec or who are intolerant to the therapy. In the majority of cases, relapses have been linked to the emergence of a number of drug-resistant mutant forms of the tyrosine kinase BCR-ABL. The single mutant that has been the most challenging to inhibit is the T315I mutant. Neither Gleevec nor the two more recently approved CML treatments, Sprycel(R) and Tasigna(R), inhibit the T315I mutant. SGX393 inhibits both wild-type BCR-ABL and many drug resistant mutant forms of BCR-ABL, including the T315I mutation.
"Filing of this IND submission represents another testament to our internal capabilities. We continue to focus on moving our discovery and development programs forward," said Mike Grey, CEO of SGX Pharmaceuticals.
SGX393 was discovered by SGX utilizing FAST(TM), its fragment based approach to drug discovery. SGX393 initially fell within the purview of the Company's collaboration with the Novartis Institute for Biomedical Research (Novartis). SGX obtained the right to further develop and commercialize SGX393 following an amendment to its agreement with Novartis that was signed in September 2007, and it is subject to a reacquisition right of Novartis which may be exercisable at a future date.
About SGX Pharmaceuticals
SGX Pharmaceuticals, Inc. is a biotechnology company focused on the discovery, development and commercialization of novel, targeted therapeutics directed at addressing unmet medical needs in oncology. The Company's drug development programs target the MET receptor tyrosine kinase, an enzyme implicated in a broad array of cancers, and the BCR-ABL tyrosine kinase enzyme for the treatment of CML. The Company's drug discovery activities are focused on a portfolio of other protein and enzyme targets that have been implicated in human cancers, including JAK2, RON, ALK, RAS and IKKe. 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 SGX393 as a treatment for CML, 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, 2007, the Company's quarterly report on Form 10-Q for the three months ended March 31, 2008, 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.