AIM ImmunoTech advances bid to study Ampligen as therapy for Post-COVID-19 Cognitive Dysfunction
AIM ImmunoTech Inc has progressed a step further in its bid to get Ampligen into a clinical trial to test it as an infusion therapy for Post-COVID-19 Cognitive Dysfunction (PCCD) – a new and serious coronavirus-induced disease for which there is currently no treatment.
The FDA has deemed a meeting request sufficient for transfer now to the regulator’s Division of Neurology by the FDA’s Covid scientific technical triage team.
The planned Phase 2 randomized, double blind, placebo controlled, multicenter study will be managed by Amarex Clinical Research and is designed to evaluate the efficacy and safety of Ampligen in patients experiencing PCCD.
READ: AIM ImmunoTech offers a status update on its pending Phase 2a Human Challenge Trial using its flagship drug Ampligen
“We are pleased with this next step - the referral to the FDA’s Division of Neurology - as our focus is on the brain-related symptoms of Long COVID,” said AIM CEO Thomas K. Equels in a statement.
The trial will see 80 patients randomized 1:1 to receive twice-weekly infusions of Ampligen or placebo for 12 weeks.
Dr. Kazem Kazempour, Amarex Clinical Research CEO, added: “FDA alignment with the strategy illustrates a positive step forward in finding a treatment for PCCD.
“Moreover, it is both exciting and gratifying to be working on this product for AIM. This is a new and serious COVID-induced disease indication for which there is currently no treatment.”
AIM ImmunoTech Inc 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 [email protected]
Story by ProactiveInvestors
Source: https://www.proactiveinvestors.com/companies/news/960893/aim-immunotech-advances-bid-to-study-ampligen-as-therapy-for-post-covid-19-cognitive-dysfunction-960893.html
Anyone can join.
Anyone can contribute.
Anyone can become informed about their world.
"United We Stand" Click Here To Create Your Personal Citizen Journalist Account Today, Be Sure To Invite Your Friends.
Please Help Support BeforeitsNews by trying our Natural Health Products below!
Order by Phone at 888-809-8385 or online at https://mitocopper.com M - F 9am to 5pm EST
Order by Phone at 866-388-7003 or online at https://www.herbanomic.com M - F 9am to 5pm EST
Order by Phone at 866-388-7003 or online at https://www.herbanomics.com M - F 9am to 5pm EST
Humic & Fulvic Trace Minerals Complex - Nature's most important supplement! Vivid Dreams again!
HNEX HydroNano EXtracellular Water - Improve immune system health and reduce inflammation.
Ultimate Clinical Potency Curcumin - Natural pain relief, reduce inflammation and so much more.
MitoCopper - Bioavailable Copper destroys pathogens and gives you more energy. (See Blood Video)
Oxy Powder - Natural Colon Cleanser! Cleans out toxic buildup with oxygen!
Nascent Iodine - Promotes detoxification, mental focus and thyroid health.
Smart Meter Cover - Reduces Smart Meter radiation by 96%! (See Video).