Genprex Inc (NASDAQ:GNPX) (FRA:2DE) 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).
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 PLC’s (LON:AZN) (NASDAQ:AZN) Tagrisso (osimertinib) in patients with late-stage NSCLC with mutated epidermal growth factor receptors (EGFRs) and 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 CEO Rodney Varner in a statement.
READ: Genprex initiates site recruitment for Acclaim-2 clinical trial for its lung cancer drug REQORSA
“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,” Verner added.
An IRB is a US Food and Drug Administration (FDA) registered constituted group of medical professionals 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, Genprex received the FDA's Fast Track Designation for its Acclaim-1 patient population. The company recently completed the manufacturing and scaled-up clinical-grade production of REQORSA to supply the drug product for its upcoming Acclaim clinical trials.
The company said it expects to conduct the Acclaim-1 clinical trial at about 15 US clinical sites with the participation of about 92 patients (with up to 18 patients in the Phase 1 component and up to 74 patients in the Phase 2 component).
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