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Actuate Receives FDA Orphan Drug Designation for Elraglusib for Treatment of Soft Tissue Sarcomas
Elraglusib is a Class-Leading GSK-3β Inhibitor with a Novel, Multimodal Mechanism of Action in Multiple Refractory Cancer TrialsOrphan Drug Designation in
About this update from Actuate Therapeutics, Inc.
[{"type":"text","content":"Elraglusib is a Class-Leading GSK-3β Inhibitor with a Novel, Multimodal Mechanism of Action in Multiple Refractory Cancer TrialsOrphan Drug Designation in Soft Tissue Sarcomas Expands Company’s Potential to Address Cancers with High Unmet Medical Need CHICAGO and FORT WORTH, Texas, Sept. 11, 2024 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage biopharmaceutical company, focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for elraglusib, a novel GSK-3β inhibitor for treatment of soft tissue sarcoma (STS). “We are pleased to receive the ODD from the FDA, which underscores elraglusib’s potential to address the significant yet unmet medical needs for patients with advanced cancers,” said Daniel Schmitt, President & Chief Executive Officer of Actuate. “Elraglusib is a leading GSK-3β inhibitor that has demonstrated a favorable safety profile and antitumor activity across several solid tumors including melanoma, Ewing sarcoma, colorectal and pancreatic cancers. We look forward to the continued development of elraglusib and working closely with regulators to deliver its promise to cancer patients.” According to the American Cancer Society, it is projected that in 2024 alone, approximately 13,590 new cases of soft tissue sarcoma will be diagnosed in the United States. Additionally, an estimated 5,200 individuals are expected to die from this disease1. “Soft tissue sarcomas are a rare but heterogeneous mix of tumors with >70 histological subtypes identified to date making sarcoma difficult to treat. Surgery remains the most effective treatment for localized cancer with median survival approaching 50%. However, patients with metastatic disease have a median overall survival of less than 6-12 months and remain a therapeutic challenge. Doxorubicin, approved almost 50 years ago, remains the recommended 1st line systemic treatment despite exhibiting minimal antitumor activity highlighting the unmet medical need for patients with metastatic STS,” said Dr. Steven D. Reich, Senior VP, Clinical Development and Acting Chief Medical Officer of Actuate. “Preclinical studies have demon...