Genprex Inc (NASDAQ:GNPX) (FRA:2DE) is gearing up to enroll patients in its Acclaim-1 clinical trial evaluating its lead drug candidate REQORSA in combination with AstraZeneca PLC’s (LON:AZN) (NASDAQ:AZN) Tagrisso (osimertinib) for late-stage non-small cell lung cancer following a review from regulator the US Food and Drug Administration (FDA).
The latter has reviewed and confirmed that all comments have been addressed regarding the protocol for the trial, which is an open-label, multi-center Phase 1/2 study testing the drug combined with Tagrisso in those whose disease has progressed after treatment with Tagrisso.
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Genprex received FDA fast track designation for the Acclaim-1 patient population in early 2020 and today, the company also revealed it had engaged the first clinical site for the trial.
"This feedback from the FDA on our Acclaim-1 clinical trial and the engagement of our first clinical site are key milestones for Genprex," said Rodney Varner, CEO of Genprex.
"We are now looking forward to opening patient enrollment in this important study of this cutting-edge investigational gene therapy to evaluate the role it can play in the fight against lung cancer, the leading cause of cancer deaths worldwide."
The first part of the Phase 1/2 clinical trial will see up to 18 patients enrolled at three clinical sites and will be a dose escalation study.
In the Phase 2 portion, it is expected that around 74 patients will be enrolled at up to 15 sites.
The primary endpoint of the Phase 2 portion of the trial is progression-free survival, defined as time from randomization after first progression on Tagrisso, to first event (second progression) or death. An interim analysis will be performed at 51 events, said Genprex.
Genprex is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes.
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