AIM ImmunoTech Inc (NYSE:AIM) announced that its Phase 2 study of Ampligen as a therapy for locally advanced pancreatic cancer (LAPC) has commenced after its trial protocol received approval from an Institutional Review Board (IRB).
The company’s Phase 2 study Investigational New Drug (IND) application for Ampligen was previously cleared by the US Food and Drug Administration (FDA).
The clinical trial (AMP-270) is designed to measure the efficacy of Ampligen against a no-treatment control group in subjects with locally advanced pancreatic adenocarcinoma (a type of pancreatic cancer) previously treated with Folfirinox. Secondary objectives include comparing safety and tolerability.
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“Receiving IRB approval for our Phase 2 study of Ampligen for the treatment of LAPC is the pivotal precursor to the recruitment, enrollment and treatment of patients with locally advanced pancreatic cancer,” CEO Thomas Equels said.
AMP-270 is expected to enroll approximately 90 subjects in up to 30 centers across the US and Europe, the company said. The Buffett Cancer Center at the University of Nebraska Medical Center and Erasmus MC in the Netherlands are expected to be the primary study sites.
“We expect study sites to be open and recruiting patients in (late 3Q/early 4Q) of 2022, with every hope of first dose in the first patient by the end of (4Q) 2022,” said Kazem Kazempour, CEO of Amarex Clinical Research, AIM’s contract research organization for AMP-270.
Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com
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