Arog Pharmaceuticals Receives FDA Fast Track Designation for Crenolanib in Relapsed or Refractory FLT3-Positive AML

DALLAS, Dec. 01, 2017 -- Arog Pharmaceuticals, Inc., a privately held, clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs to treat unmet medical needs in oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for crenolanib for the treatment of patients with FLT3 mutation-positive relapsed or refractory acute myeloid leukemia.

Crenolanib is an orally bioavailable benzimidazole type I kinase inhibitor that selectively and potently inhibits signaling of wild-type and mutant isoforms of class III receptor tyrosine kinases FLT3 and PDGFRα/β. Crenolanib can be safely administered at maximal doses in combination with 7+3 induction and high dose cytarabine (HiDAC) consolidation. The company is preparing for a Phase 3 multicenter, randomized, double-blinded, placebo-controlled, trial of oral crenolanib versus placebo in combination with best supportive care in subjects with FLT3 mutation-positive relapsed or refractory acute myeloid leukemia.

FDA's Fast Track program facilitates the development of drugs intended to treat serious or life-threatening conditions and that have the potential to address unmet medical needs. A drug program with Fast Track status is afforded greater access to the FDA for the purpose of expediting the drug's development, review and potential approval.

About Arog Pharmaceuticals, Inc.

Arog Pharmaceuticals is a private, clinical-stage biopharmaceutical company that has leveraged its platform of benzimidazole derivatives to develop a robust drug pipeline of orally available, potent, and selective small molecule type I tyrosine kinase inhibitors (TKIs).  Arog is undergoing preparations for pivotal, randomized Phase III trials of its lead molecule, crenolanib.  For more information, please visit the company’s website, http://www.arogpharma.com.

About Crenolanib 

Arog’s lead molecule, crenolanib, is a type I TKI that selectively and potently inhibits signaling of wild-type and mutant isoforms of class III receptor tyrosine kinases (RTKs), FLT3 and PDGFRα/β. Crenolanib has an established record of patient safety and has been used to treat over 350 patients. Crenolanib has been clinically investigated in combination with standard induction or salvage chemotherapy in patients with FLT3 mutant acute myeloid leukemia (AML). Additionally, crenolanib is being clinically investigated in solid tumors, including gastrointestinal stromal tumors (GIST) harboring the PDGFRα D842V mutation.

About FLT3 

FLT3 is a class III RTK, and its signaling is considered important for the normal development of hematopoietic stem cells and progenitor cells.  The FLT3 gene is one of the most frequently mutated genes (~30%) in AML.  One such mutation, internal tandem duplications of FLT3 (FLT3-ITD), is a prognostic indicator associated with adverse disease outcome.

About PDGFRα D842V Mutations  

PDGFRA^D842V is a gain-of-function mutation that constitutively activates PDGFRA downstream signaling pathway. D842V is the most common PDGFRA mutation and is well-known to be resistant to imatinib and sunitinib.    

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The Trout Group
Peter Rahmer
(646) 378-2973
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