Orlando, Florida, July 07, 2020 (GLOBE NEWSWIRE) -- Immune Therapeutics, Inc. (OTC Pink: IMUN) (“Immune” “IMUN” or the “Company”), a biopharmaceutical company focused on the development of therapies for the treatment of Infectious diseases continues to move forward on the restructuring of the Company and hopes to be able to announce its progress against goals later this month. The Company is looking to complete its previously reported 1000:1 reverse stock split, to reduce its outstanding debt obligations through licensing of intellectual property and to raise new equity capital to strengthen its balance sheet.
Meanwhile, Immune Therapeutics today was notified by Cytocom Inc. where Immune holds a major equity stake of their successful Type B pre-IND meeting with the U.S. Food and Drug Administration (FDA) in relation to the Cytocom’s planned Phase 2 clinical trial of CYTO-201 for the treatment of SARS-CoV-2, the virus responsible for COVID-19. Based on the FDA’s feedback, Cytocom plans to revise the study protocol and quickly initiate enrollment.
“We are very excited by the progress that Cytocom has demonstrated to advance the work on Cyto -201 in the fight against the virus” stated Kevin Phelps, CEO of Immune. “We recognize that Cytocom’s success enhances Immune’s shareholder value. As such, we continue to look for opportunities to support their efforts and to find novel projects where we can consider direct collaboration”.
Noreen Griffin, Cytocom President, noted that Cytocom has proposed a randomized, Phase 2 study to evaluate the safety and efficacy of CYTO-201 as a treatment to slow or halt the progression of the SARS-CoV-2 infection from mild/moderate (stage 1-2A) to severe (stage 2B-3).
She indicated that the FDA provided guidance on Cytocom’s plans for the proposed Phase 2 trial, as well as expedited review paths and 505(b)(2) premarketing requirements for CYTO-201. Cytocom provided the agency with data from preclinical in vitro studies that demonstrated the potential of CYTO-201 to inhibit the replication of the SARS-CoV-2 virus in human lung cells. Further, Cytocom has demonstrated in previous human studies that CYTO-201 can dampen harmful inflammation and possibly promote protection from reinfection. These are particularly important features in the fight to tamp down the spread of COVID-19.
Michael Handley, Cytocom CEO, stated, “Our positive interactions with the FDA, combined with the expedited regulatory process, places CYTO-201 on an accelerated positive NDA submission path. This represents a significant milestone for Cytocom and patients suffering from the debilitating and life threatening consequences that stem from COVID-19.”
About Immune Therapeutics, Inc.
Immune Therapeutics is a biopharmaceutical company focused on the development and commercialization of highly innovative therapies for use in infectious disease. Immune has an equity position in Cytocom.
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.
This release may contain forward-looking statements. Actual results may differ from those projected due to a number of risks and uncertainties, including, but not limited to, the possibility that some or all the matters and transactions considered by the Company may not proceed as contemplated, and by all other matters specified in the Company’s filings with the Securities and Exchange Commission. These statements are made based upon current expectations that are subject to risk and uncertainty. The Company does not undertake to update forward-looking statements in this news release to reflect actual results, changes in assumptions or changes in other factors affecting such forward-looking information. Assumptions and other information that could cause results to differ from those set forth in the forward-looking information can be found in the Company’s filings with the Securities and Exchange Commission (www.sec.gov), including its recent periodic reports.
Immune Therapeutics: Kevin Phelps (888) 613-8802 www.immunetherapeutics.com