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AIM ImmunoTech Reports Second Quarter 2022 Financial Results and Provides Corporate Update– On track to commence Phase 2 study for lead program evaluating Ampligen® (rintatolimod) for the treatment of pancreatic cancer in Q3 2022 – Well-positioned to achieve multiple near-term clinical and regulatory value-driving milestones – Capital position expected to fund company through end of 2023 OCALA, Fla., Aug. 15, 2022 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE: American AIM) (“AIM” or the “Company”), 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 disease caused by the SARS-CoV-2 virus, today reported its financial results for the second quarter 2022 and provided a business update. “As the second quarter results demonstrate, we believe we are closer than ever to unlocking Ampligen’s commercial potential,” commented Thomas K. Equels, Chief Executive Officer of AIM. “Notably, we have recently seen the publication of positive clinical data regarding several unmet medical needs in highly lethal malignancies. We have a strong clinical development program, sufficient operating capital and enough Ampligen to support new clinical trials. Despite ongoing headwinds for the biotech sector, we believe we are well-positioned to take advantage of the value-driving catalysts across our pipeline and look forward to generating near- and long-term shareholder value. Finally, we remain focused on delivering sufficient data on Ampligen in oncology, which we believe could contribute to significant value creation.” 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 four post-COVID patients with new onset ME/CFS following acute COVID-19. Following at least 12 weeks of Ampligen treatment, each of these four patients 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, AIM is working toward filing an IND application with the FDA for a Phase 2 study of Ampligen for the treatment of post-COVID conditions. Recent Ampligen Data Publications
Summary of Financial Highlights for Second Quarter 2022
Please refer to the full 10-Q for complete details. About AIM ImmunoTech Inc. AIM ImmunoTech Inc. is 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 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) authorized by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center and AIM plans to initiate 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 treatments and COVID-19 Long Hauler treatment. For more information, please visit aimimmuno.com and connect with the Company on Twitter, LinkedIn, and Facebook. 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. Investor Relations Contact A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/bcfbd967-0f59-46ff-b5dc-ddf3c985efb1
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