TPX-0005 (in trials for ROS1+ cancers) receives orphan drug designation

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)

Read the BusinessWire press release:

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

 

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Gray Connections

I was diagnosed with non-small cell lung cancer in May 2011. The cancer became metastatic in October 2011. No, I never smoked anything (except a salmon). I've had no evidence of disease since January 2013 thanks to precision medicine, clinical trials, and other patients. ANYONE can get lung cancer. Using my engineering degrees (MIT SBME 1978, Caltech Aeronautics MS 1984 and ENGR 1986), I enjoyed a 20-year career in aerospace systems engineering as a technical translator of sorts: I researched a scientific or engineering subject and helped others understand how this new gizmo could benefit them. In the time I have left, I want to use my skills to help others who have lung cancer, and increase the visibility and knowledge of lung cancer among those who don't. I also study brain research, enjoy traveling, write science fiction, and geek out about all sorts of science stuff.