Cytocom, Inc. Announces Successful Completion of Type-B Pre-IND Meeting with FDA Regarding Proposed Phase 2 Clinical Trial of CYTO-201 in COVID-19 Patients

WINTER PARK, Fla., June 29, 2020 /PRNewswire/ -- Cytocom, Inc. (Cytocom), a private clinical-stage biopharmaceutical company developing novel immune modulating therapies targeting cancer, autoimmune, inflammatory, and infectious diseases based on proprietary platforms, announced today the successful completion of a Type B pre-IND meeting with the U.S. Food and Drug Administration (FDA) in relation to the Company'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.

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).

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 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 a balance 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.

Forward-Looking Statements:
This release contains forward-looking statements that involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties inherent in research and development; the uncertainties inherent in business and financial planning, including, without limitation, risks related to Cytocom's business and prospects, adverse developments in Cytocom's markets, or adverse developments in the U.S. or global capital markets, credit markets, regulatory environment or economies generally; the impact of COVID-19 on our business, operations and financial results; and competitive developments.  The Company assumes no obligation to update forward-looking statements contained in this release as a result of new information or future events or developments.

Contact:

Tiberend Strategic Advisors, Inc.
Investors
Maureen McEnroe, CFA/Miriam Weber Miller
212-375-2664/212-375-2694
[email protected] 
[email protected]

Media
Johanna Bennett
212-375-2686
[email protected]

SOURCE Cytocom, Inc.