PharmAbcine Announces FDA Orphan Drug Designation Granted to TTAC-0001 for Glioblastoma Multiforme

PharmAbcine announced that U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its leading clinical compound TTAC-0001 for “treatment of Glioblastoma Multiforme.”

“We are very pleased with this Orphan Drug Designation from FDA for TTAC-0001 for GBM treatment since we have been preparing for clinical studies of TTAC-0001 plus KEYTRUDA (pembrolizumab) combo therapy for recurrent GBM in addition to TTAC-0001 mono therapy for recurrent GBM progressed after bevacizumab treatment. It will accelerate the progress of TTAC-0001 to provide clinical benefit in the treatment of GBM,” said Dr. Jin-San Yoo, president and chief executive officer of PharmAbcine, Inc.

The FDA Office of Orphan Products Development grants Orphan Drug Designation to investigational drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Orphan drug status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including seven years of market exclusivity upon regulatory product approval, exemptions from certain FDA application fees, and tax credits for qualified clinical trials costs.