FORT COLLINS, Colo.,
Feb. 16, 2021 /PRNewswire/
-- Cytocom, Inc., a leading biopharmaceutical company creating
first second-generation immune therapies, today provided an update
regarding its CYTO-200 portfolio of clinical programs.
Cytocom has submitted an Investigational New Drug (IND)
application with updated protocols to the U.S. Food and Drug
Administration (FDA) to begin a Phase 2 clinical trial, to evaluate
the safety and efficacy of CYTO-205 to slow or halt the progression
of the SARS-CoV-2, the virus that causes COVID-19. Preclinical
in vitro studies using coronavirus strain 229E have
demonstrated the potential of CYTO-205 to inhibit the replication
of a coronavirus (strain 229E) in human lung cells. The trial,
titled, "A Randomized, Placebo-Controlled, Phase 2 Study to
Evaluate Safety and Efficacy of CYTO-205 in Adult Patients With
Mild COVID-19 Infection Who Are at High Risk for Disease
Progression," is expected to begin in the second quarter of
2021 upon FDA clearance of the IND. In preparation for the start of
the trial, Cytocom has invested in manufacturing clinical supplies
of CYTO-205.
Michael K. Handley, President and
CEO of Cytocom, stated, "Despite the recent launch of several
COVID-19 vaccines, there remains a tremendous need for effective
therapies for those infected with SARS-CoV-2, especially in light
of the emergence of highly contagious new variants of the virus. To
date, research has provided compelling rationale for the potential
CYTO-205 could have as both a therapeutic intervention and as a
prophylactic agent to reduce the spread of the disease, and we look
forward to working with the FDA to advance the drug's development
and bring a therapeutic to patients suffering from the potentially
life-threatening consequences of COVID-19."
In separate news, Cytocom has entered into an agreement with
ICON plc (NASDAQ: ICLR), a global contract research organization
(CRO), to manage its upcoming Phase 3 clinical trial for its lead
drug candidate, CYTO-201, as a treatment for Crohn's disease.
"We are pleased with the progress we are making in our CYTO-200
clinical program, which includes Phase 3-ready assets in Crohn's
disease, fibromyalgia and multiple sclerosis, as well as our
COVID-19 therapy, CYTO-205," stated Mr. Handley. "CYTO-201 is the
program's lead clinical asset and we are pleased to have ICON as
our CRO partner given the company's proven expertise and track
record of clinical excellence. Meanwhile, with the filing of the
Phase 2 IND for CYTO-205 in COVID-19 and corresponding
manufacturing, we are steadily advancing our efforts to address the
significant need for COVID-19 therapies."
CYTO-200 Clinical Programs
The goals of the CYTO-200 programs are to treat patients by
restoring immune homeostasis. Our clinical programs include
CYTO-205 in COVID-19, and three Phase 3-ready development programs
for the treatment of Crohn's disease (CYTO-201), fibromyalgia
(CYTO-202) and multiple sclerosis (CYTO-203).
CYTO-205 and COVID-19
CYTO-205 is designed to modulate immune system function by
decreasing elevated inflammatory responses associated with viral
infection. Preclinical in vitro studies have demonstrated
the potential of CYTO-205 to inhibit the replication of a Corona
virus (strain 229E) in human lung cells. Further, early-stage
clinical data suggest that CYTO-205 could prevent or dampen the
potentially life-threatening lung inflammation caused by COVID-19
and possibly promote protection from reinfection. These are
particularly important features in the fight to reduce the global
spread of COVID-19.
CYTO-201 and Crohn's Disease
As Cytocom's lead investigational drug candidate, CYTO-201, is
being studied in Crohn's disease, an inflammatory bowel disease
that causes chronic inflammation of the gastrointestinal (or
digestive) tract, causing symptoms such as persistent diarrhea,
abdominal pain and rectal bleeding. Crohn's is a progressive
disease, meaning it gets worse over time. Studies show that because
the signs and symptoms of the disease are unpredictable patients
living with the disease endure significant burdens, not only
physical, but also motional and economic.
About Cytocom
Cytocom, Inc. is a clinical-stage biopharmaceutical company
developing novel immunotherapies targeting autoimmune,
inflammatory, infectious diseases and cancers based on a
proprietary platform designed to rebalance the body's immune system
and restore homeostasis. Cytocom is developing therapies designed
to elicit directly within patients a robust and durable response of
antigen-specific killer T-cells and antibodies, thereby activating
essential immune defenses against autoimmune, inflammatory,
infectious diseases, and cancers. Specifically, Cytocom has four
programs in late-stage clinical development in Crohn's disease,
fibromyalgia, multiple sclerosis and pancreatic cancer. Cytocom
believes that its 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. Cytocom's immunomodulatory
technology restores the 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 within cells like cancer and viruses through
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.
Furthermore, the Cytocom technology antagonizes the toll-like
receptors to inhibit pro-inflammatory cytokines. To learn more
about Cytocom, Inc., please visit www.cytocom.com .
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.
Maureen McEnroe, CFA/Miriam Miller (Investors)
(212) 375-2664 / 2694
mmcenroe@tiberend.com
mmiller@tiberend.com
Johanna Bennett (Media)
(212) 375-2686
jbennett@tiberend.com
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SOURCE Cytocom, Inc.