Actuate Therapeutics Announces FDA Acceptance Of IND Application For 9-ING-41 and Clearance to Proceed With Clinical Study in Patients With Advanced Cancers

CHICAGO and FORT WORTH, Texas, Feb. 20, 2018 /PRNewswire-iReach/ -- Actuate Therapeutics, Inc., a clinical stage biopharmaceutical company, today announced that on February 15, 2018, the U.S. Food and Drug Administration (FDA) accepted the company's Investigational New Drug (IND) application for 9-ING-41, a Glycogen Synthase Kinase beta (GSK-3β) inhibitor, and provided authorization to proceed with treatment of patients. This IND application supports the initiation of the international 1801 clinical study, Actuate's phase 1/2 study of 9-ING-41 in patients with refractory hematologic malignancies or solid tumors. Actuate submitted its IND for the 1801 study to the FDA on January 16, 2018.

"We are very pleased with the FDA's timely acceptance of our IND application. Their permission to proceed with moving 9-ING-41 into the clinic is a vital step. It is a great privilege to be working with leading US and European investigators on the 1801 study" said Frank Giles, MD, Chief Medical Officer of Actuate. "9-ING-41 has demonstrated activity in a broad range of solid tumors and lymphomas in preclinical models – this is reflected in the multi-histology eligibility design of our first study where we will study both the efficacy of single agent 9-ING-41 and when it is combined with standard anti-cancer cytotoxic agents."

"In the 1801 study, with colleagues in leading EU and US cancer centers, we will move 9-ING-41 into the clinic – a long awaited opportunity to offer patients a clinically viable GSK-3β inhibitor, said Christophe Massard MD, Chief of the Drug Development Department (DITEP) of Gustave Roussy, Villejuif, France and a lead investigator on the 1801 study. "GSK-3β is a potentially very important target in cancer and we are particularly excited to explore 9-ING-41's ability to reverse chemoresistance in patients with a spectrum of refractory cancers. The study will also allow us to refine our understanding of the role of GSK-3β in cancer and how best to predict which cancers may best respond to its modulation with 9-ING-41"

"The 1801 study will serve as a basis for designing future registration studies in adult and pediatric cancers, as well as providing critical information for developing our agents for the treatment of patients with systemic pathological fibrosis not associated with cancers" said Daniel Schmitt, President & CEO. "FDA clearance of the IND is a key milestone for the company, and a potentially important one for patients suffering from difficult-to-treat malignancies. The international scientific collaborations that have helped us achieve this milestone so rapidly are particularly gratifying."

About Actuate Therapeutics, Inc.

Actuate is a clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics for cancers and inflammatory diseases.  For additional information, please visit the Company's website at

Media Contact: Public Relations Dept., Actuate Therapeutics, Inc., 847-986-4190,

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SOURCE Actuate Therapeutics, Inc.



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