Semafore's SF1126 for B-cell chronic lymphocytic leukemia granted FDA orphan drug designation

Nov 9 2010

Semafore Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the Company's SF1126 product candidate for the treatment of B-cell chronic lymphocytic leukemia (CLL). In April 2010, the Company initiated an expansion of its ongoing Phase I clinical study into this disease setting. SF1126 is a novel peptidic prodrug that converts to LY294002, one of the most widely studied small molecule inhibitors of both phosphatidylinositol 3-kinase (PI3K) and mammalian target of rapamycin (mTOR).

“We are committed to developing SF1126 as a potential treatment for this disease and look forward to presenting interim clinical data at ASH.”

"SF1126 is the first PI3K inhibitor to receive orphan drug designation from the FDA for the treatment of CLL, which is an important milestone for Semafore Pharmaceuticals," said Joseph Garlich, Ph.D., Semafore's Chief Scientific Officer. "We are committed to developing SF1126 as a potential treatment for this disease and look forward to presenting interim clinical data at ASH."

SF1126 will be the subject of a poster presentation at the 52nd American Society of Hematology (ASH) Annual Meeting and Exposition being held December 4-7, 2010 in Orlando, FL. A summary of the presentation is below, and the full abstract can be accessed on the ASH website at www.hematology.org.

Phase I Study of Novel Prodrug Dual PI3K/mTOR Inhibitor SF1126 In B-Cell Malignancies

• Saturday, December 4, 2010, 5:30 p.m. to 7:30 p.m. Eastern Time (ET)
• Abstract number: 1783
• Poster Session: Lymphoma - Chemotherapy, excluding Pre-Clinical Models: Poster I
• Location: Hall A3/A4, Poster Board I-763
• Senior author: Daruka Mahadevan, MD, Ph.D., Arizona Cancer Center, University of Arizona, Tucson, AZ