Winter Park, Florida--(Newsfile Corp. - June 9, 2020) - Immune Therapeutics, Inc. (OTC Pink: IMUN), announced today that equity partner, Cytocom, Inc., has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to study CYTO-201 for the treatment of COVID-19. The submission has been reviewed by the COVID-19 Scientific/Technical Triage Team and has been assigned for review by the Division of Pulmonology, Allergy and Critical Care (DPACC), part of the Office of Immunology and Inflammation (OII).
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The proposed randomized open-label Phase II study is intended to evaluate the safety and efficacy of CYTO-201 as an adjunct to the clinical standard of care treatment. CYTO-201 will be assessed to evaluate safety and effectiveness as an anti-COVID-19 treatment to mitigate the progression of the disease from mild/moderate (stage 1-2A) to severe (stage 2B-3).
"We are advancing the clinical development of CYTO-201 as adjunctive therapy against COVID-19 because an effective treatment for COVID-19 could come from a combination of drugs," said Clifford Selsky, MD PhD, Chief Medical Officer of Cytocom, Inc. "We look forward to collaborating closely with leading clinical investigators and the FDA to validate the effectiveness of CYTO-201 in treating COVID-19 in a controlled clinical setting."
"While we are hopeful a vaccine will become quickly available, we feel therapeutic drugs will always be necessary for a virus that is prone to rapid mutation such as the SARS-CoV-2 virus. We are currently evaluating our own immuno-modulating drugs in our pipeline for testing and potential repurposing as treatments for COVID-19," said Michael K. Handley CEO of Cytocom, Inc. "Evidence has shown that CYTO-201 will target cellular pathways that will mitigate inflammation and enhance immune cell function. We know from current clinical work that enhanced immune cell function and reduction in inflammation should result in reduction of the viral load, hospital duration, and the clinical severity of SARS-CoV-2 infections."
About Cytocom, Inc.:
Cytocom, Inc. is a clinical-stage biopharmaceutical company developing novel immunotherapies targeting autoimmune, inflammatory, infectious diseases and cancers based on a proprietary platform that is designed to rebalance body's immune system. We are using our therapies to elicit directly within patients a powerful and durable response of antigen-specific killer T cells and antibodies, thereby activating essential immune defenses against autoimmune, inflammatory, infectious diseases and cancers. We believe that our technologies can meaningfully leverage the human immune system for prophylactic and therapeutic purposes by eliciting killer T cell response levels not achieved by other published immunotherapy approaches. Our platform technology as immunomodulatory is to restore is a balance of the immune system between the cellular (Th1) and the humoral (Th2) immune systems. Immune balance is regulated through T-helper cells that produce cytokines. The Th1 lymphocytes help fight pathogens that are within cells like cancer and viruses through activation of interferon-gamma and macrophages. The Th2 lymphocytes target external pathogens like cytotoxic parasites, allergens, toxins through the activation of B-cells and antibody production.to effect to dendritic cells, which are natural activators of killer T cells, also known as cytotoxic T cells, or CD8+ T cells.
About Immune Therapeutics, Inc.:
Immune Therapeutics, Inc. is a biopharmaceutical company focused on the development and commercialization of highly innovative therapies for use in infection disease. Immune Therapeutics owns an equity interest in Cytocom, Inc.
Immune Therapeutics' Cautionary Note on Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. Words such as "may", "expect", "anticipate" "hope", "vision", "optimism", "design", "exciting", "innovative", "promising", "will", "conviction", "estimate," "intend," "believe", "quest for a cure of cancer", "innovation-driven", "paradigm-shift", "high scientific merit", "impact potential" and similar expressions are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about future plans, the progress, timing, clinical development, scope and success of future clinical trials, the reporting of clinical data for the company's product candidates and the potential use of the company's product candidates to treat various cancer indications. Each of these forward-looking statements involves risks and uncertainties and actual results may differ materially from these forward-looking statements. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. These risks are not exhaustive, the company faces known and unknown risks, including the risk factors described in the company's annual report on Form 10-K filed with the SEC on April 10, 2019 and in the company's other periodic filings. Forward-looking statements are based on expectations and assumptions as of the date of this press release. Except as required by law, the company does not assume any obligation to update forward-looking statements contained herein to reflect any change in expectations, whether as a result of new information future events, or otherwise.
Michael K. Handley, CEO
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