AIM ImmunoTech Inc. - AIM STOCK NEWS

AIM ImmunoTech has submitted an Investigational New Drug (IND) application for its drug Ampligen to the FDA, seeking Fast Track status for a Phase 2 study targeting late-stage pancreatic cancer. The AMP-270 trial will include around 250 participants, comparing Ampligen plus standard care against standard care alone. Early data from a prior study reported a median overall survival increase of 6.7 months for Ampligen-treated patients. AIM's application aims to enhance development and review processes for potential therapies addressing serious medical conditions.

AIM ImmunoTech Inc. (NYSE American: AIM) has released safety data from a Phase 1 clinical study of its drug Ampligen, highlighting its potential as an intranasal treatment for COVID-19. The study involved 40 healthy subjects, showing that Ampligen is generally well tolerated with no severe adverse events reported. Following these positive safety results, AIM is advancing towards a Phase 2a Human Challenge Trial and filing a Pre-Investigational New Drug application with the FDA for further studies. Results for immunological activity are expected in Q4 2021.

AIM ImmunoTech has finalized the Phase 2 study protocol for Ampligen, targeting late-stage pancreatic cancer. The company plans to submit an IND and apply for Fast Track designation by October 18, 2021. The study will be managed by Amarex Clinical Research, with the Buffett Cancer Center and Erasmus MC as lead sites. Early-access data revealed a significant increase in overall survival (19.2 months) for Ampligen-treated patients compared to a control group (12.5 months). The trial will include approximately 250 subjects and aims to assess Ampligen's efficacy when combined with standard care.

AIM ImmunoTech Inc. has announced a Clinical Trial Agreement for a Phase 2a Human Challenge Trial of Ampligen, targeting intranasal prophylaxis against respiratory viruses. Conducted by hVIVO, the trial is set to enroll 64 healthy participants, who will be exposed to human rhinovirus and influenza A to evaluate Ampligen's efficacy. The study is pending approval from the Oxford Research Ethics Committee, with expectations to start in Q4 2021. A successful trial could position Ampligen as a viable prophylactic against current and future viral threats.

AIM ImmunoTech has submitted a Pre-Investigational New Drug application (Pre-IND) to the FDA for two Phase 2 studies to evaluate Ampligen’s potential as a treatment for early-onset COVID-19. These randomized, double-blind trials will assess Ampligen as both an intravenous therapy (200 mg) and an intranasal spray (1,250 μg). Preliminary data suggest Ampligen could boost immunity against respiratory viruses and reduce SARS-CoV-2 infectious viral yields by 90%. The company aims to validate its provisional patent for Ampligen, highlighting its significant therapeutic potential.

AIM ImmunoTech Inc. (NYSE American: AIM) announced a provisional patent application for Ampligen, designed as an early-onset intranasal therapy aimed at enhancing immunity against RNA respiratory viruses, including SARS-CoV-2. The therapy targets viral replication and aims to induce a broader immune response. Upcoming clinical trials will focus on intranasal therapeutic effects and exploratory endpoints to validate Ampligen's potential. AIM’s COVID-19 patent portfolio includes multiple provisional applications for ampligen-related treatments, reflecting its commitment to combat viral diseases.

AIM ImmunoTech Inc. (NYSE American: AIM) has made significant strides in its Phase 2 clinical study of Ampligen for treating Post-COVID-19 Cognitive Dysfunction (PCCD). The U.S. FDA has accepted AIM’s meeting request, facilitating a referral to the Division of Neurology. The trial will include 80 participants receiving either Ampligen or a placebo over 12 weeks. Both AIM CEO Thomas K. Equels and Amarex Clinical Research’s CEO Dr. Kazem Kazempour expressed optimism regarding this regulatory alignment, highlighting the potential for a new treatment addressing cognitive symptoms of Long COVID.

AIM ImmunoTech Inc. (NYSE American: AIM) announced an update on its Phase 2a Human Challenge Trial for its drug Ampligen, targeting intranasal prophylactic therapy against human rhinovirus (HRV-16) and influenza A virus (H3N2). The study protocol was submitted to the Oxford Research Ethics Committee, with a review meeting scheduled for September 24, 2021. The trial plans to enroll 64 participants in a double-blind setup to evaluate Ampligen's efficacy. A successful outcome may position Ampligen as a preventative treatment for various respiratory viruses. AIM is collaborating with hVIVO to finalize a Clinical Trial Agreement.

AIM ImmunoTech Inc. (NYSE American: AIM) has submitted a Pre-Investigational New Drug application to the FDA for a Phase 2 clinical study of Ampligen, aimed at treating Post-COVID-19 Cognitive Dysfunction (PCCD). This randomized, double-blind, placebo-controlled study will involve 80 participants receiving Ampligen or placebo for 12 weeks. The preliminary IND filing is deemed a major milestone and could potentially alleviate the debilitating effects of PCCD, which impacts cognitive function and daily activities. AIM also filed a provisional patent for Ampligen as both intravenous and intranasal therapy for PCCD.