Genprex Inc has announced a plan to accelerate the opening of trial sites for the Acclaim-1 clinical trial, which combines the company’s lead product candidate, REQORSA (quaratusugene ozeplasmid) Immunogene Therapy, with AstraZeneca’s Tagrisso as a potential innovative treatment for non-small cell lung cancer (NSCLC).
The company said the opening of four clinical trial sites to enroll patients in the Phase 1 portion of Genprex’s Acclaim-1 clinical trial is underway as part of a collaboration agreement with a large network of integrated, community-based oncology practices, with an expectation of opening additional sites in the Phase 2 portion of the study.
“We are pleased to target community based oncology practices for the conduct of our Acclaim-1 clinical trial,” Genprex chief medical officer Mark Berger said in a statement.
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“Not only does this approach provide cancer patients with access to innovative oncology treatments at the office of their primary oncologist, it also allows Genprex to more readily access patients for the clinical trial and move it forward in a more efficient and expeditious manner,” Berger added.
“Our Acclaim-1 trial offers a unique opportunity to transform cancer care for patients with advanced lung cancer who have EGFR mutations that are no longer responsive to standard targeted therapies.”
Genprex noted it expects the Phase 1 portion of the Acclaim-1 trial to enroll up to 18 patients in a dose escalation study to determine the maximum tolerated dose of the combination.
The Phase 2 portion of the study is expected to enroll about 74 patients to be randomized 1:1 to receive either REQORSA and Tagrisso combination therapy or Tagrisso monotherapy.
The company added that the primary endpoint of the Phase 2 portion of the trial is progression-free survival, which is defined as time from randomization to progression or death. An interim analysis will be performed at 25 events.
Genprex is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. The company’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.
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