SGX Pharmaceuticals Submits Investigational New Drug Application for SGX393
Monday June 30, 6:00 am ET
SAN DIEGO, June 30 /PRNewswire-FirstCall/ -- SGX Pharmaceuticals (Nasdaq: SGXP - News) 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®. 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® and Tasigna®, 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.
About SGX393
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.
surf's up......crikey
