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DALLAS, Nov. 07, 2016 (GLOBE NEWSWIRE) -- 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 its abstract highlighting the company’s lead product candidate, crenolanib, in a combination study with cytarabine and anthracycline has been selected for an oral presentation at the 2016 American Society of Hematology (ASH) annual meeting. Crenolanib continues to demonstrate best-in-class properties in the treatment of acute myeloid leukemia (AML) with FLT3 mutations. In addition, AROG will present three posters on its combination studies of crenolanib with sorafenib, idarubicin and high-dose ara-C (HiDAC), and high-dose ara-C and mitoxantrone (HAM) in AML patients with FLT3 mutations. The ASH annual meeting will take place December 3-6, 2016 in San Diego, California. Details of the abstract presentations are provided below. Title: Crenolanib, a type I FLT3 TKI, can be safely combined with cytarabine and anthracycline induction chemotherapy and results in high response rates in patients with newly diagnosed FLT3 mutant acute myeloid leukemia (AML) Presenter: Dr. Eunice S. Wang Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: FLT3 and IDH Targeted Therapies in AML Date: Monday, December 5, 2016 Session Time: 4:30 PM - 6:00 PM PST Presentation Time: 5:00 PM PST Location: San Diego Ballroom AB (Marriott Marquis San Diego Marina) Title: Pilot study of combined type I FLT3 tyrosine kinase inhibitor, crenolanib with sorafenib in pediatric patients with relapsed/refractory FLT3+Ve AML Authors: Hiroto Inaba, John C Panetta, Daelynn R. Buelow, Raul C. Ribeiro, John R. Eckardt, and Sharyn D. Baker Title: Efficacy of a type I FLT3 inhibitor, crenolanib, with idarubicin and high-dose ara-c in multiply relapsed/refractory FLT3+ AML Title: Safety study of salvage chemotherapy high-dose ara-c/mitoxantrone (HAM) and Type I FLT3TKI crenolanib in first relapsed/primary refractory AML 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 III trials of its lead molecule, crenolanib.  In addition to the four clinical trials it has already completed, AROG is also engaged in three 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 250 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.


DALLAS, Nov. 16, 2016 (GLOBE NEWSWIRE) -- 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. 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.


Patent
AROG Pharmaceuticals LLC | Date: 2013-09-13

The present invention includes a method of inhibiting or reducing deregulated FLT3 tyrosine kinase activity or FLT3 tyrosine kinase expression in a subject with a proliferative disease by administering to the subject having or suspected to have the proliferative disease, a therapeutically or prophylactically effective amount of the compound of Formula I: or pharmaceutically acceptable salt thereof.


Patent
AROG Pharmaceuticals LLC | Date: 2013-09-13

The present invention includes a method of reducing or inhibiting the kinase activity of C-KIT mutant tyrosine kinase activity in a cell or a subject, and the use of such compound for treating mutant C-KIT driven cell proliferative disorder(s) in a subject related to using a compound of the present invention: or pharmaceutically acceptable salt thereof.


Patent
Arog Pharmaceuticals LLC | Date: 2015-05-04

The present invention relates to the use of crenolanib, in a pharmaceutically acceptable salt form for the treatment of FLT3 mutated proliferative disorders driven by constitutively activated mutant FLT3, and to a method of treatment of warm-blooded animals, preferably humans, in which a therapeutically effective dose of crenolanib is administered to an animal suffering from said disease or condition:


Patent
Arog Pharmaceuticals LLC | Date: 2016-09-02

The present invention includes a method of reducing or inhibiting the kinase activity of C-KIT mutant tyrosine kinase activity in a cell or a subject, and the use of such compound for treating mutant C-KIT driven cell proliferative disorder(s) in a subject related to using a compound of the present invention: or pharmaceutically acceptable salt thereof.


Patent
AROG Pharmaceuticals LLC | Date: 2015-03-27

The present invention includes a method of inhibiting or reducing deregulated FLT3 tyrosine kinase activity or FLT3 tyrosine kinase expression in a subject with a proliferative disease by administering to the subject having or suspected to have the proliferative disease, a therapeutically or prophylactically effective amount of the compound of Formula I: or pharmaceutically acceptable salt thereof.


Patent
Arog Pharmaceuticals LLC | Date: 2013-10-14

The present invention relates to the use of crenolanib, in a pharmaceutically acceptable salt form for the treatment of FLT3 mutated proliferative disorders driven by constitutively activated mutant FLT3, and to a method of treatment of warm-blooded animals, preferably humans, in which a therapeutically effective dose of crenolanib is administered to an animal suffering from said disease or condition:


Patent
AROG Pharmaceuticals LLC | Date: 2014-07-30

The present invention includes a method of inhibiting or reducing deregulated FLT3 tyrosine kinase activity or FLT3 tyrosine kinase expression in a subject with a proliferative disease by administering to the subject having or suspected to have the proliferative disease, a therapeutically or prophylactically effective amount of the compound (CP-673,451) of Formula I: or pharmaceutically acceptable salt thereof.


Patent
Arog Pharmaceuticals Inc. | Date: 2016-06-28

The present invention relates to the use of crenolanib, in a pharmaceutically acceptable salt form for the treatment of FLT3 mutated proliferative disorders driven by constitutively activated mutant FLT3, and to a method of treatment of warm-blooded animals, preferably humans, in which a therapeutically effective dose of crenolanib is administered to an animal suffering from said disease or condition:

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