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DALLAS, Nov. 21, 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 European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has granted orphan drug designation for its lead product candidate, crenolanib, for the treatment of acute myeloid leukemia (AML) and soft tissue sarcoma. Crenolanib also recently received Fast Track designation from the U.S. Food and Drug Administration (FDA) 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 orphan designation from the EMA along with our U.S. fast track designation positions crenolanib for an accelerated global regulatory product development pathway to address unmet needs of patients with AML, and soft tissue sarcoma including GIST with a D842V mutation in the PDGFRA gene,” said Vinay Jain, M.D., Chief Executive Officer of Arog. “We will continue to aggressively advance our clinical development of crenolanib and look forward to providing updates on our ongoing Phase 3 trials for these indications.” Acute myeloid leukemia is life-threatening due to its rapid progression and its 5-year survival of approximately 22% with current treatments and chronically debilitating due to the consequences of bone marrow dysfunction, such as intracranial or gastro-intestinal hemorrhagic episodes, disseminated intravascular coagulation, and the risk of severe infections. The condition is estimated to affect approximately 1 in 10,000 people in the European Union. Soft tissue sarcoma is chronically debilitating with a high recurrence and metastasis rate, and life-threatening with an overall 5-year survival rate of approximately 60%. The condition is estimated to affect approximately 2.8 in 10,000 people in the European Union. To receive orphan drug designation from the EMA, a medicinal product must be intended for the treatment of a life-threatening or a chronically debilitating rare disease affecting not more than 5 in 10,000 individuals in the European Union (EU), and have the potential to be of significant benefit to those affected by that condition. Orphan drug designation provides incentives designed to facilitate development, including protocol assistance, reduced fees for regulatory activities and up to ten years of market exclusivity in the EU upon marketing approval for the designated indication. 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 2 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.


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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