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Ambit Biosciences and Teva Announce Clearance of an Investigational New Drug (IND) Application for CEP-32496, A Novel BRAF(V600E) Inhibitor
Date:5/17/2012

SAN DIEGO and JERUSALEM, May 17, 2012 /PRNewswire/ -- Ambit Biosciences and Teva Pharmaceutical Industries Limited (NASDAQ: TEVA) ("Teva") today announced the clearance of an Investigational New Drug application (IND)  with the U.S. Food and Drug Administration (FDA) for CEP-32496, a novel BRAF (V600E) kinase inhibitor. 

The IND filing was based upon promising therapeutic potential for this agent, as evidenced by data revealed in recent publications in the Journal of Medicinal Chemistry and Molecular Cancer Therapeutics characterizing the preclinical properties of CEP-32496. The two publications feature results that demonstrate CEP-32496 is a selective and potent inhibitor of BRAF (V600E) in cells.  The published preclinical findings also demonstrate that CEP-32496 possesses potent and sustained anti-tumor activity in xenograft models of melanoma and colon carcinoma.  CEP-32496 possesses attractive pharmacokinetic properties upon oral administration and benchmarks favorably with respect to other kinase inhibitors that have activity at the BRAF (V600E) mutated kinase. 

"The data that we have generated to date in these preclinical studies lead us to believe that we have a promising drug candidate with CEP-32496 and is further validation of our successful drug discovery collaboration with Ambit," said Bruce Ruggeri, Ph.D., Senior Director, Oncology and Inflammation Discovery Research of Teva. "We look forward to exploring the full potential of this drug candidate to improve outcomes in patients with tumors possessing the BRAF(V600E) mutation."

Added Michael A. Martino, Ambit's President and Chief Executive Officer, "The filing of this IND represents a significant milestone for the Teva-Ambit coll
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SOURCE Ambit Biosciences
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