On November 30, 2020 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that it has commenced clinical trial site recruitment for its upcoming Acclaim-1 clinical trial for the treatment of non-small cell lung cancer (NSCLC) (Press release, Genprex, NOV 30, 2020, View Source [SID1234571977]). As planned, the timing of the patient recruitment and enrollment puts the Company on track for its Acclaim-1 clinical trial to commence in the first-half of 2021.
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Acclaim-1 is an open-label, multi-center Phase 1/2 clinical trial that combines Genprex’s lead drug candidate, REQORSA immunogene therapy with AstraZeneca PLC’s Tagrisso in patients with late stage NSCLC with mutated epidermal growth factor receptors (EGFRs), whose disease progressed after treatment with Tagrisso. Genprex received U.S. Food and Drug Administration (FDA) Fast Track Designation for its Acclaim-1 patient population in January of 2020.
"Our clinical team is engaging with prestigious cancer centers and research institutions across the U.S. to ensure we select optimal study sites, which play an important role in the success of a clinical trial," said Rodney Varner, President and Chief Executive Officer of Genprex. "We look forward to working with leading clinical investigators who will help drive our mission to bring forth a treatment for advanced lung cancer patients."
The Company plans to conduct the Acclaim-1 clinical trial in approximately 10 U.S. sites with about 100 patients (9-18 patients in the Phase 1 component and 82 patients in the Phase 2 component). An interim analysis will be performed after 53 events (i.e., progression of disease or death).
Additional information on the Acclaim-1 clinical trial can be found by visiting ClinicalTrials.gov.