AIM ImmunoTech enrolling patients in coronavirus-induced chronic fatigue trial of Ampligen

AIM ImmunoTech Inc (NYSEAMERICAN:AIM) (FRA:HXB2) announced Thursday that it has received approval from the Institutional Review Board (IRB) to notify the public of potential openings in its Ampligen Expanded Access Program for coronavirus patients.  The Ampligen EAP protocol is authorized to enroll up to 100 active trial participants, 20 of whom can be long haulers, a subset of coronavirus patients with symptoms that can extend for months. The program is being conducted by Charles Lapp at Hunter-Hopkins Center in Charlotte, North Carolina and Daniel Peterson at Sierra Internal Medicine in Incline Village, Nevada. Enrollment is an important milestone in AIM's program to develop Ampligen as a therapy for those who will suffer from SARS-CoV-2-induced chronic fatigue, including many with brain fog. The program was initially a trial of Ampligen as a treatment for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), but the company received approval to widen the trial to include coronavirus long haulers in October. READ: AIM ImmunoTech drug Ampligen gets FDA orphan status as pancreatic cancer treatment "It is anticipated that COVID-19 will trigger a large number of long haulers suffering COVID-induced brain impairment and disabling fatigue,” Lapp said in a statement. “I believe the investigational immune-modulating antiviral drug Ampligen might have a role to play as a future therapy. I believe the data to date suggests that early treatment will lead to better levels of efficacy." Ampligen is AIM's TLR3 agonist immune-system modulator. It has been approved in Argentina as the world's first therapy for severe Chronic Fatigue Syndrome and is the only late-stage drug in the US development pipeline for ME/CFS. "A hypothesis-based re-analysis of CFS patients treated with Ampligen in a randomized-controlled study showed that CFS patients with shorter duration of CFS symptoms were more than twice as likely to respond to Ampligen than the group as a whole,” Peterson said. “We are cautiously optimistic that early Ampligen treatment of post-COVID-19 patients with long hauler chronic fatigue will have the potential to induce a clinically beneficial outcome.” In June, the pharmaceutical firm filed a provisional utility patent application for Ampligen to be used as a possible treatment for chronic fatigue associated with COVID-19. "While major global pharmaceutical companies have understandably focused their efforts on developing COVID-19 vaccines, AIM believes there is an equally essential need to help post-COVID-19 patients ..,” AIM CEO Thomas Equels said. “We hope that the treatment of long hauler patients in our AMP-511 clinical trial can help us to quickly determine whether Ampligen has potential as an important therapy for this post-COVID-19 syndrome. If successful, this may change millions of lives for the better." Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com Follow him on Twitter @andrew_kessel