AIM ImmunoTech Inc (NYSE:AIM) revealed that it has received a notification from the US Food and Drug Administration (FDA) stating that the clinical hold on the company’s investigational new drug (IND) application for a Phase 2 study of its flagship drug candidate Ampligen as a therapy for locally advanced pancreatic cancer (AMP-270) has been lifted.
The Ocala, Florida-based immuno-pharma company said that it can now proceed with the study.
"Based on the data we've seen to date, we believe Ampligen has the potential to offer an important treatment option to patients living with pancreatic cancer,” said AIM ImmunoTech CEO Thomas Equels in a statement. “Our team is focused on commencing our Phase 2 study which we believe brings us another step closer to providing a potentially effective therapy after systemic chemotherapy in patients with advanced pancreatic cancer."
The AMP-270 clinical trial is planned to be a randomized, open-label, controlled, parallel-arm study with the primary objective of comparing the effectiveness of Ampligen versus a no treatment control group following FOLFIRINOX for subjects with locally advanced pancreatic adenocarcinoma.
AIM said secondary objectives include comparing safety and tolerability. The firm plans to enroll around 90 subjects across up to 30 centers in the US and Europe. The Buffett Cancer Center at the University of Nebraska Medical Center (UNMC) and Erasmus MC in the Netherlands are expected to be the primary study sites. Amarex Clinical Research will manage the AIM-sponsored Phase 2 study.
Meanwhile, Professor Casper HJ van Eijck, who is the Pancreato-biliary Surgeon at Erasmus MC, said: “The longer median Progression Free Survival and overall survival rates of our patients treated with Ampligen that we have seen already are very encouraging and warrant further evaluation.”
“With this devastating disease where there remains a need for more effective therapies, we are excited to advance the development of this important asset that has shown promise in addressing that need. I believe Ampligen has the potential to be a meaningful extension to the standard of care for advanced pancreatic cancer."
Professor Michael A Hollingsworth of the Buffett Cancer Center at UNMC added that they are “excited” to undertake the clinical trial and studies to better understand the mechanism by which Ampligen may extend survival of pancreatic cancer patients.
The same sentiments were echoed by Professor Kelsey Klute from the Buffett Cancer Center at UNMC, who noted that Ampligen has shown “promising activity” in treating pancreatic cancer in the Erasmus Program and in preclinical models.
“This is an important step toward formally testing its activity in patients affected by this devastating disease," added Klute.
Ampligen is being developed to fight important cancers, viral diseases, and immune system disorders and has demonstrated in the clinic the potential for standalone effectiveness in several solid tumors. Ampligen has also shown success in increasing survival rates and efficacy in the treatment of animal tumors when used in combination with checkpoint blockade therapies. It is currently being evaluated as a combo therapy for treating solid tumor types in multiple clinical trials. Ampligen is also being used as a monotherapy to treat pancreatic cancer patients in an Early Access Program (EAP) approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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