Arog Pharmaceuticals Receives FDA Fast Track Designation for Crenolanib for Advanced Gastrointestinal Stromal Tumors with a D842V Mutation in the PDGFRA Gene
DALLAS, Nov. 16, 2016 -- 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 unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRα) D842V mutation.
“This is a significant milestone for our clinical pipeline and we are pleased to receive this Fast Track designation,” said Vinay Jain, M.D., Chief Executive Officer of Arog. “This decision from the FDA confirms that crenolanib has the potential to address this serious condition and the unmet medical need in patients with GIST with a D842V mutation in the PDGFRA gene.”
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. The company is currently recruiting patients for a Phase 3 multicenter, randomized, double-blinded, placebo-controlled, trial of oral crenolanib versus oral placebo in combination with best supportive care in subjects with unresectable or metastatic GIST with a D842V mutation in the PDGFRA gene. Approximately 120 subjects will be randomized in a 2:1 ratio to receive either crenolanib 100 mg or matching placebo orally (PO) 3 times daily (TID) in combination with best supportive care.
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 kinase inhibitors. Arog is poised to enroll patients in pivotal, randomized Phase 3 trials of its lead molecule, crenolanib. In addition to the six clinical trials it has already completed, Arog is also engaged in five ongoing Phase II clinical trials. For more information, please visit the company’s website, http://www.arogpharma.com.
AROG’s lead molecule, crenolanib, is currently being clinically investigated as a treatment for multiple cancers, including acute myeloid leukemia (AML), gastrointestinal stromal tumors (GIST), glioma, and non-small cell lung cancer (NSCLC). It 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. This molecule has an established record of patient safety and has been used to treat over 300 patients from around the world.
FLT-3 is a class III receptor tyrosine kinase, and its signaling is considered important for the normal development of hematopoietic stem cells and progenitor cells. The FLT-3 gene is one of the most frequently mutated genes (~35%) in acute myeloid leukemia (AML). One such mutation, internal tandem duplications of FLT-3 (FLT3-ITD), is a prognostic indicator associated with adverse disease outcome. Also, FLT-3 (FLT3-D835), is known to be a common cause of resistance to other FLT3 inhibitors.
Platelet-derived growth factor receptors (PDGFR) -α and -β are cell surface tyrosine kinase receptors and are important factors regulating cell proliferation and cell development, as well as several diseases, including cancers like brain tumors and sarcomas. In clinical tests, crenolanib has been shown to inhibit both PDGFR-α and -β phosphorylation, thus preventing downstream signaling.
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