FORT COLLINS, Colo.,
Aug. 9, 2021 /PRNewswire/
-- Cytocom Inc. (NASDAQ: CBLI), a leading
biopharmaceutical company creating next-generation immune therapies
that focus on immune restoration and homeostasis, today
provided an update regarding its portfolio of clinical
programs.
"We are excited and believe that we are well positioned to
further the development of our clinical-stage pipeline and showcase
the power of our expanded post-merger drug development
capabilities," stated Michael K.
Handley, President and CEO of Cytocom. "We are strategically
focused on immune-modulating treatments designed to address anemia
and neutropenia, emergent viruses, cancer, and autoimmune
diseases."
Mr. Handley continued, "The coming months will be busy. We are
completing the necessary steps to begin enrolling patients by
year-end 2021 in a Phase 3 clinical trial for our lead drug
candidate, CYTO-201, for the treatment of Crohn's disease. Building
on our legacy Cytocom pipeline are the Cleveland BioLabs assets,
specifically entolimod, an immune-stimulatory agent. We are eager
to explore new indications for entolimod and remain excited about
the potential for toll-like receptor 5 agonists in treating
neutropenia and anemia in cancer patients. Our team is working to
put together development plans in hematology and we are in talks
with a renowned medical facility to begin a clinical study using
entolimod in the coming months."
Mr. Handley concluded, "In addition, we plan to follow in the
first half of 2022 with a clinical trial exploring CYTO-401 as an
adjunct to standard of care therapy to extend the duration of
disease remission in patients with pancreatic cancer. We are
also completing the necessary steps to activate clinical trial
sites and begin enrolling patients in clinical trials exploring
CYTO-205 in patients with acute and post-acute COVID-19. This could
be a particularly compelling opportunity given the pernicious
nature of the SARS-CoV-2 virus, which, despite growing vaccination
rates, continues to impact millions of people worldwide. What's
more, the medical community has specifically expressed interest on
a "long haulers" study."
CYTO-201 and Crohn's Disease
Cytocom's lead
investigational drug candidate, CYTO-201, is being studied for the
treatment of pediatric patients with 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. 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 emotional and economic.
On July 27, 2021, Cytocom
completed a successful end of Phase 2 meeting with the U.S. Food
and Drug Administration (FDA) regarding a clinical development plan
for a Phase 3 clinical trial evaluating CYTO-201 in pediatric
Crohn's patients. Cytocom is partnering with ICON plc, a global
contract research organization (CRO), to manage the trial, and
expects to begin enrolling patients by year-end 2021.
Entolimod and Hematology
Cytocom's new management team
is now reviewing information regarding the past development work
for entolimod, as well as previous clinical trial data. The company
plans to address the clinical hold imposed by the U.S. Food and
Drug Administrations (FDA) in 2019 in order to initiate clinical
trials for new indications. In addition to continuing work on the
Acute Radiation Syndrome or ARS, Cytocom plans to explore new
indications for entolimod based on the potential of toll-like
receptor 5 agonists in hematology indications, specifically the
treatment of neutropenia and anemia in cancer patients. Cytocom is
developing a hematology program and discussions are underway with a
renowned academic institution to potentially initiate the first
study later this year using entolimod in a hematology
indication.
CYTO-401 and Pancreatic Cancer
Cytocom is developing
CYTO-401 as an adjunct to standard of care therapy to extend the
duration of disease remission in patients with pancreatic
cancer. In August 2021, the company
received FDA feedback regarding the clinical development program.
Having feedback on the development program and establishing an
advisory panel of oncology experts, Cytocom is now evaluating
contract research organizations (CROs) and is planning to initiate
the clinical trial in the first half of 2022.
CYTO-205 and Acute and Post-Acute COVID-19
With the
FDA having cleared an Investigational New Drug (IND) application,
Cytocom expects to begin a Phase 2 clinical trial in the third
quarter of 2021 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.
Cytocom is finalizing protocols for a study evaluating CYTO-205
in patients with post-acute COVID-19 syndrome (PACS). Also known as
"long haulers," these patients represent a high unmet medical need
with roughly 30% of all COVID-19 infections developing into
long-haul syndrome. Cytocom plans to conduct the trial under the
existing IND and expects to begin enrolling patients by year-end
2021. CYTO-205 is designed to modulate immune system function by
decreasing elevated inflammatory responses associated with viral
infection.
About Cytocom
Cytocom Inc. is a clinical-stage
biopharmaceutical company developing novel immunotherapies
targeting autoimmune, neutropenia/anemia, emerging viruses and
cancers based on a proprietary platform designed to rebalance the
body's immune system and restore homeostasis. The company also has
one of the largest platforms of toll-like immune receptors (TLR4,
TLR5 and TLR9) in the biopharmaceutical industry, addressing
conditions such as radiation sickness and cancer treatment side
effects. 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 several
clinical-stage development programs for Crohn's disease,
hematology, pancreatic cancer, and COVID-19 in addition to
expansion to fibromyalgia and multiple sclerosis. To learn more
about Cytocom Inc., please visit www.cytocom.com.
Forward Looking Statements:
This press
release contains forward-looking statements that involve risks and
uncertainties. All statements other than statements of current or
historical fact contained in this press release, including
statements regarding the expected clinical development timeline for
its product candidates. The words "anticipate," "believe,"
"continue," "should," "estimate," "expect," "intend," "may,"
"plan," "project," "will," and similar expressions, as they relate
to us, are intended to identify forward-looking statements. We have
based these forward-looking statements on the current expectations
about future events held by management. While we believe these
expectations are reasonable, such forward-looking statements are
inherently subject to risks and uncertainties, many of which are
beyond our control. The company's actual future results may differ
materially from those discussed here for various reasons. The
company discusses many of these risks under the heading "Risk
Factors" in the proxy statement/prospectus filed with the SEC on
June 10, 2021, as updated by the
company's other filings with the SEC. Factors that may cause such
differences include, but are not limited to, the outcome of any
legal proceedings that have been or may be instituted against the
company related to the merger with Cleveland BioLabs; unexpected
costs, charges or expenses resulting from the merger; our need for
additional financing to meet our business objectives; our history
of operating losses; our ability to successfully develop, obtain
regulatory approval for, and commercialize our products in a timely
manner; our plans to research, develop and commercialize our
product candidates; our ability to attract collaborators with
development, regulatory and commercialization expertise; our plans
and expectations with respect to future clinical trials and
commercial scale-up activities; our reliance on third-party
manufacturers of our product candidates; the size and growth
potential of the markets for our product candidates, and our
ability to serve those markets; the rate and degree of market
acceptance of our product candidates; regulatory requirements and
developments in the United States,
the European Union and foreign countries; the performance of our
third-party suppliers and manufacturers; the success of competing
therapies that are or may become available; our ability to attract
and retain key scientific or management personnel; our historical
reliance on government funding for a significant portion of our
operating costs and expenses; government contracting processes and
requirements; the exercise of significant influence over our
company by our largest individual stockholder; the impact of the
novel coronavirus ("COVID-19") pandemic on our business, operations
and clinical development; the geopolitical relationship
between the United States and the
Russian Federation as well as
general business, legal, financial and other conditions within the
Russian Federation; our ability to
obtain and maintain intellectual property protection for our
product candidates; our potential vulnerability to cybersecurity
breaches; and other factors discussed in our SEC filings, including
our Annual Report on Form 10-K for the year ended December 31, 2020 and the risk factors discussed
under the heading "Risk Factors" in the proxy statement/prospectus
the company filed in connection with the merger on June 10, 2021.
Given these uncertainties, you should not place undue
reliance on these forward-looking statements. The forward-looking
statements included in this press release are made only as of the
date hereof. We do not undertake any obligation to update any such
statements or to publicly announce the results of any revisions to
any of such statements to reflect future events or
developments.
Contacts:
Cytocom, Inc.
Nichol Ochsner
Senior V.P. Investor Relations and Corporate Communications
(732) 754-2545
nichol.ochsner@cytocom.com
Tiberend Strategic Advisors, Inc.
Maureen McEnroe, CFA (Investors)
(212) 375-2664
mmcenroe@tiberend.com
Johanna Bennett (Media)
(212) 375-2686
jbennett@tiberend.com
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SOURCE Cytocom Inc.