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AIM ImmunoTech Reports Third Quarter 2022 Financial Results and Provides Corporate Update– Company continues to execute and is well-positioned to achieve multiple near-term clinical and regulatory value-driving milestones – Cash position expected to fund operations through end of 2023 OCALA, Fla., Nov. 15, 2022 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”), an immune-pharma company 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, today reported its financial results for the third quarter 2022 and provided a business update. “Over the course of 2022 and throughout this past quarter, we have remained focused on successfully executing on our clinical development programs. I am incredibly pleased with the progress we’ve made and am excited for what remains ahead of us. Not only have we delivered on our commitments by initiating studies, but we have also commenced enrollment and are on track to reach targeted milestones that lay on the horizon. As we enter the final stretch for 2022, I believe we are well-positioned to reach the value-driving catalysts across our pipeline. We have been, and will continue to be, committed to generating near- and long-term value for all stakeholders,” commented Thomas K. Equels, Chief Executive Officer of AIM. Recent Highlights
Clinical Program Update Ampligen® (rintatolimod): dsRNA being developed for globally important cancers, viral diseases and disorders of the immune system Ampligen has demonstrated in the clinic the potential for standalone efficacy in a number of solid tumors. Additionally, Ampligen has shown therapeutic synergy with checkpoint inhibitors, including increasing survival rates and efficacy, in the treatment of animal tumors when used in combination with checkpoint blockade therapies. The first detection of Ampligen’s synergistic potential with checkpoint blockade therapeutics was witnessed in pre-clinical mouse models of melanoma and pancreatic cancers. Additionally, the Company now has data from two clinical studies — in advanced recurrent ovarian cancer and triple negative breast cancer — that indicate that the drug may have similar anti-tumor activity in humans. Ampligen is being evaluated as a combinational therapy for the treatment of a variety of solid tumor types in multiple clinical trials – both underway and planned – at major cancer research centers around the U.S. Ampligen is also being used to treat pancreatic cancer patients in an Early Access Program (EAP) approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center. Immuno-Therapy Targeting Multiple Cancers with High Unmet Need
Broad-Spectrum Immune System Response Against SARS-CoV-2 (COVID-19) Previous animal studies yielded positive results utilizing Ampligen in Western Equine Encephalitis Virus, Ebola, Vaccinia Virus (which is used in the manufacture of smallpox vaccine) and SARS-CoV-1. The Company has conducted experiments in SARS-CoV-2 showing Ampligen has a powerful impact on viral replication. The prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against SARS-CoV-2. AIM is currently evaluating the safety and effectiveness of intravenous Ampligen to reduce replication of SARS-CoV-2 virus from upper airway in patients in an ongoing Phase 1/2 study for the treatment of COVID-19 cancer patients. The Company plans to conduct an intranasal study of Ampligen to potentially enhance and expand natural immunity. The FDA has authorized Ampligen in a clinical trial of patients with COVID-19 who have a pre-existing cancer. That Phase 1/2a study utilizing Ampligen is underway in the investigator-sponsored Phase 2 trial at the Roswell Park Comprehensive Cancer Center. ClinicalTrials.gov: NCT04379518 Immune System Disorders (ISD): Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) / COVID-19 Long Hauler The Company is currently sponsoring an ongoing, FDA-authorized AMP-511 (See: ClinicalTrials.gov: NCT00215813) expanded access program (EAP) for ME/CFS patients in the United States. AIM has enrolled five post-COVID patients with new onset ME/CFS following acute COVID-19. Preliminary results based on data from the first 4 patients, following at least 12 weeks of Ampligen treatment indicated they had experienced a reduction in fatigue, as measured via Patient-Reported Outcomes questionnaires. A statistical analysis of these data indicated that the decrease in fatigue compared to baseline was statistically significant (p<0.002), despite the small number of patients. Based in part on these early positive data, the FDA recently provided their clearance of the Company’s IND application for a Phase 2 study of Ampligen for the treatment of Post-COVID Conditions. The planned Phase 2 study (“AMP-518”) is a two-arm, randomized, double-blind, placebo-controlled, multicenter study to evaluate efficacy and safety of Ampligen in patients experiencing the post-COVID condition of fatigue. The primary outcome measure of the study is change from baseline to week 13 in PROMIS® Fatigue Score. Other study outcomes include: change from baseline to week 6 in PROMIS® Fatigue Score; change from baseline to week 6 and 13 in distance traveled during a 6-minute walk test; proportion of subjects with minimal clinically important difference, defined as at least 54 meters, in the Six-Minute Walk Test at the end of 12-week treatment phase; change from baseline to week 6 and 13 in PROMIS® Cognitive Function Score; change from baseline to week 6 and 13 in PROMIS® Sleep Disturbance Score; and change from baseline to week 6 and 13 in 36-Item Short Form Survey. Approximately 80 subjects between the ages of 18 to 60 years old are expected to be enrolled across up to 10 centers in the United States. Patients will be randomized 1:1 to receive twice weekly IV infusions of Ampligen or placebo for 12 weeks with a follow up phase of 2 weeks. The Company expects to commence patient enrollment and dosing in the AMP-518 study in Q1 2023. Recent Ampligen Data Publications
Summary of Financial Highlights for Third Quarter 2022
Please refer to the full 10-Q for complete details. About AIM ImmunoTech Inc. AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19. The Company’s lead product, Ampligen® (rintatolimod) is an immuno-modulator with broad spectrum activity being developed for globally important cancers, viral diseases and disorders of the immune system. Ampligen is currently 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 and AIM has commenced a Phase 2 clinical study in 2022. The Company also has multiple ongoing clinical trials to evaluate Ampligen as a combinational therapy for the treatment of a variety of solid tumor types both underway and planned at major cancer research centers. Additionally, Ampligen is approved in Argentina for the treatment of severe chronic fatigue syndrome (CFS) and is currently being evaluated in many aspects of SARS-CoV-2/COVID-19 myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and Post COVID Conditions. Cautionary Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Words such as “may,” “will,” “expect,” “plan,” “anticipate” and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. 1 dx.doi.org/10.1136/jitc-2022-SITC2022.0547 Investor Relations Contact JTC Team, LLC Jenene Thomas 833-475-8247 [email protected] |