Genprex (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing treatments for patients with cancer and diabetes, today announced its receipt of centralized Institutional Review Board (“IRB”) approval of the clinical trial protocol for its upcoming Acclaim-1 clinical trial in non-small cell lung cancer (“NSCLC”). Acclaim-1 is an open-label, multi-center Phase 1/2 clinical trial that combines the company’s lead drug candidate, REQORSA(TM) immunogene therapy, with AstraZeneca’s Tagrisso(R) (osimertinib) in patients with late-stage NSCLC with mutated epidermal growth factor receptors (“EGFRs”), whose disease progressed after treatment with Tagrisso. “The purpose of IRB review is to assure that appropriate steps are taken to protect the rights and welfare of individuals participating as subjects in clinical research,” said Rodney Varner, president and CEO of Genprex. “With this centralized IRB approval, we have achieved another significant clinical milestone. We remain focused on completing our preparations for the Acclaim-1 clinical trial and look forward to its commencement.”
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About Genprex Inc.
Genprex is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. The company’s lead product candidate, “REQORSA(TM)” (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (“NSCLC”). REQORSA has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance. In January 2020, the U.S. Food and Drug Administration granted Fast Track Designation for REQORSA for NSCLC in combination therapy with AstraZeneca’s Tagrisso(R) (osimertinib) for patients with EFGR mutations whose tumors progressed after treatment with Tagrisso. For more information, visit the company’s web site at www.Genprex.com.
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