SAN DIEGO, June 30 SGX Pharmaceuticals(Nasdaq: SGXP) today announced that it has submitted an investigational newdrug (IND) application to the U.S. Food and Drug Administration for SGX393.This compound is an internally developed, selective, orally-bioavailable smallmolecule for the treatment of relapsed and refractory chronic myelogenousleukemia (CML).
The standard of care for CML is Gleevec(R). Although Gleevec is a highlyeffective front-line therapy for CML, there are patients who relapse while onGleevec or who are intolerant to the therapy. In the majority of cases,relapses have been linked to the emergence of a number of drug-resistantmutant forms of the tyrosine kinase BCR-ABL. The single mutant that has beenthe most challenging to inhibit is the T315I mutant. Neither Gleevec nor thetwo more recently approved CML treatments, Sprycel(R) and Tasigna(R), inhibitthe T315I mutant. SGX393 inhibits both wild-type BCR-ABL and many drugresistant mutant forms of BCR-ABL, including the T315I mutation.
"Filing of this IND submission represents another testament to ourinternal capabilities. We continue to focus on moving our discovery anddevelopment programs forward," said Mike Grey, CEO of SGX Pharmaceuticals.
SGX393 was discovered by SGX utilizing FAST(TM), its fragment basedapproach to drug discovery. SGX393 initially fell within the purview of theCompany's collaboration with the Novartis Institute for Biomedical Research(Novartis). SGX obtained the right to further develop and commercializeSGX393 following an amendment to its agreement with Novartis that was signedin September 2007, and it is subject to a reacquisition right of Novartiswhich may be exercisable at a future date.
About SGX Pharmaceuticals
SGX Pharmaceuticals, Inc. is a biotechnology company focused on thediscovery, development and commercialization of novel, targeted therapeuticsdirected at addressing unmet medical needs in oncology. The Company's drugdevelopment programs target the MET receptor tyrosine kinase, an enzymeimplicated in a broad array of cancers, and the BCR-ABL tyrosine kinase enzymefor the treatment of CML. The Company's drug discovery activities are focusedon a portfolio of other protein and enzyme targets that have been implicatedin human cancers, including JAK2, RON, ALK, RAS and IKKe. More information onthe pipeline and drug discovery platform can be found athttp://www.sgxpharma.com and in the Company's various filings with theSecurities and Exchange Commission.
Forward Looking Statements
Statements in this press release that are not strictly historical innature are forward-looking statements. These statements include, but are notlimited to, the potential of SGX393 as a treatment for CML, and the ability ofthe company to discover, develop and commercialize cancer therapeutics. Thesestatements are only predictions based on current information and expectationsand involve a number of risks and uncertainties. Actual events or results maydiffer materially from those projected in any of such statements due tovarious factors, including the risks and uncertainties inherent in drugdiscovery, development and commercialization. The results of earlypreclinical studies or clinical trials may not be predictive of futureresults, and the Company cannot provide any assurances that any of itscompounds or development candidates will have favorable results in preclinicalstudies or future clinical trials or that the FDA will approve thecommencement of clinical trials. For a discussion of these and other factors,please refer to the risk factors described in the Company's annual report onForm 10-K for the year ended December 31, 2007, the Company's quarterly reporton Form 10-Q for the three months ended March 31, 2008, as well as otherfilings with the Securities and Exchange Commission. You are cautioned not top