Cytocom Updates Investigational New Drug Software for Phase 2 Clinical Trial of CYTO-205 for the Treatment method of COVID-19

FORT COLLINS, Colo., Feb. 16, 2021 /PRNewswire/ — Cytocom, Inc., a primary biopharmaceutical corporation producing initial

FORT COLLINS, Colo., Feb. 16, 2021 /PRNewswire/ — Cytocom, Inc., a primary biopharmaceutical corporation producing initial next-era immune therapies, today furnished an update regarding its CYTO-200 portfolio of clinical plans.

Cytocom has submitted an Investigational New Drug (IND) application with current protocols to the U.S. Food items and Drug Administration (Food and drug administration) to start out a Stage 2 scientific trial, to appraise the safety and efficacy of CYTO-205 to gradual or halt the development of the SARS-CoV-2, the virus that leads to COVID-19. Preclinical in vitro research making use of coronavirus pressure 229E have demonstrated the opportunity of CYTO-205 to inhibit the replication of a coronavirus (pressure 229E) in human lung cells. The trial, titled, “A Randomized, Placebo-Managed, Period 2 Examine to Consider Security and Efficacy of CYTO-205 in Grownup People With Moderate COVID-19 Infection Who Are at Large Risk for Illness Progression,” is expected to start in the 2nd quarter of 2021 on Food and drug administration clearance of the IND. In preparation for the commence of the trial, Cytocom has invested in manufacturing clinical provides of CYTO-205.

Michael K. Handley, President and CEO of Cytocom, mentioned, “In spite of the current start of numerous COVID-19 vaccines, there continues to be a large require for productive therapies for individuals contaminated with SARS-CoV-2, primarily in light-weight of the emergence of very contagious new variants of the virus. To date, analysis has presented compelling rationale for the opportunity CYTO-205 could have as each a therapeutic intervention and as a prophylactic agent to cut down the unfold of the ailment, and we appear ahead to functioning with the Fda to progress the drug’s improvement and provide a therapeutic to people struggling from the most likely daily life-threatening repercussions of COVID-19.”

In different news, Cytocom has entered into an agreement with ICON plc (NASDAQ: ICLR), a global deal investigate firm (CRO), to take care of its future Period 3 clinical trial for its lead drug prospect, CYTO-201, as a treatment method for Crohn’s illness.

“We are happy with the development we are creating in our CYTO-200 clinical application, which includes Section 3-all set assets in Crohn’s condition, fibromyalgia and several sclerosis, as very well as our COVID-19 remedy, CYTO-205,” mentioned Mr. Handley. “CYTO-201 is the program’s guide scientific asset and we are happy to have ICON as our CRO associate offered the company’s confirmed abilities and keep track of report of clinical excellence. In the meantime, with the filing of the Period 2 IND for CYTO-205 in COVID-19 and corresponding manufacturing, we are steadily advancing our endeavours to address the considerable have to have for COVID-19 therapies.”

CYTO-200 Medical Systems

The targets of the CYTO-200 programs are to take care of individuals by restoring immune homeostasis. Our medical packages include CYTO-205 in COVID-19, and three Section 3-completely ready advancement plans for the treatment method of Crohn’s sickness (CYTO-201), fibromyalgia (CYTO-202) and a number of sclerosis (CYTO-203).

CYTO-205 and COVID-19

CYTO-205 is developed to modulate immune technique perform by lowering elevated inflammatory responses involved with viral infection. Preclinical in vitro reports have shown the opportunity of CYTO-205 to inhibit the replication of a Corona virus (strain 229E) in human lung cells. Further, early-stage scientific knowledge advise that CYTO-205 could stop or dampen the potentially lifestyle-threatening lung irritation caused by COVID-19 and probably promote protection from reinfection. These are particularly essential attributes in the battle to minimize the world-wide spread of COVID-19.

CYTO-201 and Crohn’s Disease

As Cytocom’s guide investigational drug candidate, CYTO-201, is staying researched in Crohn’s illness, an inflammatory bowel disease that triggers long-term swelling of the gastrointestinal (or digestive) tract, causing indicators this kind of as persistent diarrhea, abdominal soreness and rectal bleeding. Crohn’s is a progressive disease, indicating it gets even worse about time. Research demonstrate that for the reason that the signs and signs of the ailment are unpredictable patients residing with the ailment endure sizeable burdens, not only actual physical, but also motional and financial.

About Cytocom

Cytocom, Inc. is a clinical-phase biopharmaceutical enterprise acquiring novel immunotherapies concentrating on autoimmune, inflammatory, infectious conditions and cancers primarily based on a proprietary platform designed to rebalance the body’s immune program and restore homeostasis. Cytocom is acquiring therapies designed to elicit directly inside people a strong and resilient response of antigen-unique killer T-cells and antibodies, therefore activating necessary immune defenses towards autoimmune, inflammatory, infectious disorders, and cancers. Specially, Cytocom has four courses in late-stage scientific development in Crohn’s disease, fibromyalgia, various sclerosis and pancreatic cancer. Cytocom believes that its systems can meaningfully leverage the human immune program for prophylactic and therapeutic needs by eliciting killer T-cell reaction degrees not obtained by other published immunotherapy techniques. Cytocom’s immunomodulatory know-how restores the balance among the cellular (Th1) and the humoral (Th2) immune devices. Immune stability is regulated by means of T-helper cells that make cytokines. The Th1 lymphocytes assistance battle pathogens in cells like cancer and viruses by way of interferon-gamma and macrophages. The Th2 lymphocytes concentrate on exterior pathogens like cytotoxic parasites, allergens, toxins via the activation of B-cells and antibody production to outcome to dendritic cells, which are pure activators of killer T -cells, also recognised as cytotoxic T-cells, or CD8+ T-cells. Also, the Cytocom engineering antagonizes the toll-like receptors to inhibit professional-inflammatory cytokines. To study much more about Cytocom, Inc., please stop by www.cytocom.com .

Forward-Hunting Statements:

This release incorporates forward-wanting statements that involve considerable risks and uncertainties that could cause precise effects to differ materially from these expressed or implied by these statements. Challenges and uncertainties involve, amid other points, uncertainties inherent in study and progress the uncertainties inherent in small business and economical setting up, which include, devoid of limitation, challenges associated to Cytocom’s enterprise and prospective customers, adverse developments in Cytocom’s marketplaces, or adverse developments in the U.S. or international funds markets, credit history marketplaces, regulatory setting or economies commonly the influence of COVID-19 on our company, operations and monetary final results and aggressive developments. The Corporation assumes no obligation to update ahead-on the lookout statements contained in this release as a end result of new data or future occasions or developments.

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