On May 5, 2021 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 the Company has received 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) (Press release, Genprex, MAY 5, 2021, View Source [SID1234579219]). Acclaim-1 is an open-label, multi-center Phase 1/2 clinical trial that combines the Company’s lead drug candidate, REQORSA immunogene therapy, with AstraZeneca’s Tagrisso (osimertinib) in patients with late-stage NSCLC with mutated epidermal growth factor receptors (EGFRs), whose disease progressed after treatment with Tagrisso.
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"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 Chief Executive Officer 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."
An IRB is a U.S. Food and Drug Administration (FDA) registered constituted group of medical professionals that are responsible for reviewing and monitoring biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications (to secure approval), or disapprove research. IRB group review serves an important role in the protection of the rights, safety and welfare of human research subjects.
A centralized IRB review process involves an agreement under which multiple study sites in a multicenter trial can rely on the review of a centralized IRB, other than the IRB affiliated with each individual research site. The goal of the centralized process is to increase efficiency and decrease duplicative efforts, while enabling the central IRB to take responsibility for all aspects of IRB review at each site participating in the centralized review process.
In January 2020, the Company received FDA Fast Track Designation for its Acclaim-1 patient population. Genprex has recently completed the manufacturing and scaled-up clinical grade production of REQORSA to supply drug product for its upcoming Acclaim clinical trials.
The Company expects to conduct the Acclaim-1 clinical trial at approximately 15 U.S. clinical sites with participation of approximately 92 patients (with up to 18 patients in the Phase 1 component and up to 74 patients in the Phase 2 component). An interim analysis will be performed after 25 clinical events (i.e., disease progression or death). Additional information on the Acclaim-1 clinical trial can be found by visiting ClinicalTrials.gov.