United States, Texas, Dallas – 05-15-2020 (PRDistribution.com) — Dallas, May 15, 2020 – – Arog Pharmaceuticals, Inc., a Phase 3 biopharmaceutical company focused on the development of crenolanib and a related class of benzimidazole-based compounds to become treatment options for cancers with high unmet medical need, announced that it will feature three clinical poster presentations at the 2020 European Hematology Association (EHA) Virtual Congress, taking place June 11-14, 2020.
Poster Presentation, Abstract EP541Title: Younger Patients With Newly Diagnosed FLT3-Mutant AML Treated with Crenolanib Plus Chemotherapy Achieve Durable RemissionsAuthors: Aaron D. Goldberg, Catherine C. Coombs, Eunice S. Wang,Roland B. Walter, Chatchada Karanes, Carlos E. Vigil, Boo Messahel, Richard M. Stone, Robert H. CollinsSession Title: Acute myeloid leukemia – ClinicalAbstract Summary: Mature Phase II clinical data suggest that the combination of crenolanib with intensive chemotherapy might improve outcomes in younger patients with newly diagnosed FLT3-mutant AML. As of February 2020, the overall survival is 76.8% with a median follow-up of 43.2 months. Median event-free survival (EFS) and cumulative incidence of relapse (CIR) have not been reached. Poster Presentation, Abstract EP584Title: Clearance of Phenotypically Distinct FLT3-ITD And FLT3-TKD Clones by Treatment with Crenolanib And Chemotherapy as Detected by Longitudinal Single-Cell DNA Sequencing AnalysisAuthors: Richard M. Stone, Martha Wadleigh, Ilene Galinksy, Boo MessahelSession Title: Acute myeloid leukemia – ClinicalAbstract Summary: This study presents kinetics of clearance of multiple FLT3 mutations, including FLT3-ITD, FLT3-TKD, and multiple variant mutations, by crenolanib plus standard chemotherapy. Using single cell DNA (scDNA) sequencing we show that the patient has no FLT3 mutations remaining. Despite known adverse risk factors, this patient remains free of disease 35 months after the initial diagnosis. Poster Presentation, Abstract EP639Title: Results of A Pilot Study Combining Crenolanib With Standard Salvage Chemotherapy in Relapsed/Refractory AMLAuthors: Robert Collins, Swaminathan Padmanabhan Iyer, Yogesh S Jethava, Chatchada Karanes, Boo MessahelSession Title: Acute myeloid leukemia – Clinical
Abstract Summary: This was the first safety study combining crenolanib with standard salvage chemotherapy. The target dose of 100 mg TID crenolanib was shown to have a favorable safety and tolerability profile in this setting. Crenolanib could be administered continuously, allowing for sustained inhibition of FLT3 signaling. These results indicate that combining crenolanib with standard salvage chemotherapy could provide increased benefit, with no significant increase in toxicity, to patients with relapsed/refractory AML.About Arog Pharmaceuticals, Inc.Arog Pharmaceuticals is a Phase 3 biopharmaceutical company dedicated to developing its lead investigational drug candidate, crenolanib, and a related class of benzimidazole-based compounds to become best-in-class therapies in cancer indications with high unmet medical need.Arog was founded in 2010 to secure exclusive global rights to its product candidates from Pfizer. Since then, Arog has enrolled over 500 patients in completed or ongoing clinical trials in acute myelogenous leukemia (AML) and advanced solid tumors.About Crenolanib Crenolanib, is a next-generation type I TKI that selectively and potently inhibits signaling of wild-type and mutant isoforms of class III receptor tyrosine kinases FLT3 and PDGFR?/?. Arog is conducting pivotal, randomized Phase III trials of crenolanib designed, if successful, to secure it as a treatment option in combination with intensive chemotherapy for newly diagnosed and relapsed or refractory FLT3 AML and as monotherapy treatment for advanced or metastatic gastrointestinal stromal tumors (GIST) with a D842V mutation. For more information, please visit the company’s website, http://www.arogpharma.com.About FLT3 AMLFLT3 AML is an aggressive and deadly disease with limited targeted therapy options. FLT3 mutations are the most common driver mutations in AML, occurring in 25 – 33% of patients and are associated with increased rates of relapse and decreased survival.FLT3 mutations lead to constitutive activation of the tyrosine kinase function, making FLT3 inhibition an attractive drug target in AML patients. Adding a FLT3 inhibitor to standard chemotherapy has been shown to produce longer lasting benefits compared to chemotherapy alone. Chemotherapy offers limited benefits in treating cancer cells harboring FLT3 mutations.A polyclonal disease, multiple FLT3 mutations have been identified, including internal tandem duplications (ITD), mutations in the tyrosine kinase domain (TKD), and variant mutations. FLT3 mutations are generally regarded as poor prognostic markers in AML and a number of FLT3 mutations confer resistance to targeted inhibitors. ContactsUSA and ROWEdward McDonald, 214-593-0504Head, Corporate Developmentemcdonald@arogpharma.comEuropeCourtney Follit, Ph.D., 214-593-0545Lead, Corporate Developmentcfollit@arogpharma.comAPACHui Tian, Ph.D., 214-593-0558Director, Operationshtian@aropgharma.com
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