AIM ImmunoTech Reports 2020 Year-End Financial Results - Seite 2

Ampligen has shown heightened levels of activity in Phase 2 and 3 trials with Chronic Fatigue Syndrome patients. Ampligen, while experimental in the United States for CFS, is approved in Argentina and is the only late-stage experimental drug for CFS in the U.S. pipeline. Ampligen is also the only drug approved for severe CFS in the world. As witnessed in the prior SARS epidemic of 2002-03, 27% of hospitalized survivors met the U.S. CDC criteria for chronic fatigue syndrome. More than 30 million people in the United States have been infected with SARS-CoV-2, representing a considerable number of people facing potential COVID-induced ME/CFS-like illness in their future. All these facts support our optimism and hopes for the development of a therapy for COVID-induced chronic fatigue.

Update on Cancer Clinical Trials/Programs

Ampligen demonstrated the potential for standalone efficacy in the clinical setting in a number of solid tumors. Six Ampligen clinical trials are currently underway at university cancer centers testing whether tumor microenvironments can be reprogrammed to increase the effectiveness of cancer immunotherapy, including checkpoint inhibitors.

AIM reported receipt of statistically significant positive pancreatic cancer survival results from a multi-year Early Access Program treating 27 subjects with advanced pancreatic adenocarcinoma conducted at Erasmus University Medical Center in the Netherlands. Prof. Casper van Eijck, MD Ph.D., and his team at Erasmus MC found a statistically significantly positive survival benefit when using AIM’s drug Ampligen in patients with locally advanced/metastatic pancreatic cancer after systemic chemotherapy. Median survival was 7.0 months higher in the Ampligen arm as compared to the historical controls. A manuscript for publication is being prepared by the Erasmus MC team.

Towards this end, AIM intends to seek FDA authorization for a follow-up pancreatic cancer Phase 2/3 clinical trial and cancer centers have already expressed interest in serving as clinical sites.

Additionally, Ampligen was awarded an FDA Orphan Drug Designation for the treatment of pancreatic cancer, and a European Medicines Agency orphan medicinal product designation for pancreatic cancer. AIM intends to seek FDA fast-track status for pancreatic cancer. The company will promptly update stockholders and the market as more information on these studies becomes available.