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SGX Pharmaceuticals, Inc. (SGXP) Submits FDA Investigational New Drug Application

SGX Pharmaceuticals is a biopharmaceutical company which focuses mainly on the development and commercialization of new oncological, or cancer therapies. Yesterday, the company announced its submission of an Investigational New Drug (IND) application for FDA approval.

The drug is known as SGX393, and is currently undergoing clinical testing of its ability to treat two forms of CML, or, chronic myelogenous leukemia (a type of cancer in which white blood cells belonging to the myeloid line of cells are over-produced in the bone marrow). At present, the standard treatment for CML is a product known as Gleevec®, however there have been several cases where candidates have either relapsed, or been unresponsive or intolerant of the drug.

The majority of relapses have occurred as a result of several mutated forms of the tyrosine kinase BCR-ABL. The mutation that has caused the most trouble is known as the T315I mutant, and neither Gleevec®, nor the next two most popular CML treatments (Sprycel® and Tasigna®), have been successful in inhibiting the anomaly. SGX393 does inhibit the T315I mutant and several other drug-resistant forms of BCR-ABL. If approved by the FDA, SGX Pharmaceuticals’ SGX393 could become the preferred method of CML treatment.

Mike Grey, CEO of SGX Pharmaceuticals stated: “Filing of this IND submission represents another testament to our internal capabilities. We continue to focus on moving our discovery and development programs forward.”

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