A TP Therapeutics, Inc. drug designated TPX-0005 received FDA Orphan Drug Designation on June 27, 2017. The first patient enrolled in March 2017 in the TPX-0005 Phase 1 clinical trial for advanced solid tumors with ROS1, ALK, and NTRK rearrangements.
Here is the clinical trial listing on clinicaltrials.gov:
NCT03093116: A Study of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)
TP Therapeutics Announces FDA Orphan Drug Designation Granted to TPX-0005 for Treatment of Non-Small Cell Lung Adenocarcinomas Harboring ALK, ROS1, or NTRK Oncogenic Rearrangements
TP Therapeutics, Inc., a privately held, clinical-stage biopharmaceutical company focusing on addressing oncology drug resistance, announced today that U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its leading clinical compound TPX-0005 for “treatment of non-small cell lung adenocarcinomas harboring ALK, ROS1, or NTRK oncogenic rearrangements.”
The FDA 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. … Read More