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AIM ImmunoTech engages CRO Amarex Clinical Research to manage Phase 2 of Ampligen study

AIM ImmunoTech Inc (NYSE:AIM). has engaged Amarex Clinical Research LLC to manage the Phase 2 study of its flagship drug candidate Ampligen as a therapy for locally advanced pancreatic cancer (AMP-270), with clinical trial on track to start in the third quarter of this year. The Ocala, Florida-based immuno-pharma company recently received notification from the US Food and Drug Administration (FDA) that its Clinical Hold on AIM’s investigational new drug (IND) application for a Phase 2 study of Ampligen has been lifted. “We continue to be encouraged by the progress and data demonstrated by Ampligen for the treatment of pancreatic cancer. Over the past couple of months, we have made noteworthy advancements on multiple fronts, including FDA notice that we are authorized to proceed with our Phase 2 study,” Thomas Equels, CEO of AIM said in a statement. “We are committed to driving this program forward and working hand-in-hand with our CRO (Contract Research Organization), Amarex, to advance our Phase 2 study, which is on track to commence in the third quarter of this year.” The AMP-270 clinical trial is planned to be a randomized, open-label, controlled, parallel-arm study with the primary objective of comparing the efficacy of Ampligen versus a no-treatment control group following FOLFIRINOX for subjects with locally advanced pancreatic adenocarcinoma. The AMP-270 is expected to enroll approximately 90 subjects in up to 30 centers across the US and Europe. 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. READ: AIM ImmunoTech reports positive data from Phase 2a study evaluating Ampligen as part of a regimen treating colorectal cancer that has spread to the liver Ampligen has demonstrated in the clinic the potential for standalone efficacy in a number of solid tumors. It is currently being evaluated as a combinational therapy for the treatment of a variety of solid tumor types in multiple clinical trials – both underway and planned – at major cancer research centers around the country. Recently published data from a single-center named patient program indicated that patients receiving Ampligen had a longer median survival time than matched historical controls. For the study, patients with locally advanced pancreatic cancer (LAPC) or metastatic disease were treated with Ampligen at two doses per week with 400 milligram per infusion. “We continue to amass an encouraging growing body of data that supports our belief in Ampligen to offer an important treatment option to patients living with pancreatic cancer,” Equels added. AIM is focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus. Contact the author at jon.hopkins@proactiveinvestors.com