Semafore Pharmaceuticals announced today that the 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).
“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.