CRANFORD, N.J., Dec. 8, 2020 /PRNewswire/ -- Citius
Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a
specialty pharmaceutical company developing and commercializing
critical care drug products, today announced interim data from
a proof-of-concept ("POC") large animal study of its proprietary
induced mesenchymal stem cell ("i-MSC") therapy for
acute inflammatory respiratory conditions including COVID-19
related Acute Respiratory Distress Syndrome ("ARDS"). The available
results of i-MSC therapy in the study show improvement in
critical parameters, such as improved oxygenation, less systemic
shock, and reduced lung injury, compared to the control group. The
study was conducted in a widely accepted large animal model.
As previously announced, Citius signed an exclusive worldwide
licensing agreement with Novellus Therapeutics Limited to
develop and commercialize iPSC-derived i-MSCs. In
conjunction with the licensing agreement, the Company established a
new subsidiary, NoveCite, Inc., to develop, manufacture and
commercialize these induced mesenchymal stem cells. NoveCite has
already filed a Pre-Investigational New Drug Application (Pre-IND)
with the FDA and has received guidance on the requirements for the
proposed trials.
Citius believes that the NoveCite i-MSCs overcome some of
the challenges of human donor-derived MSCs which are often
associated with limited supply, batch inconsistencies, lower
potency, and expensive manufacturing. i-MSCs are derived
from engineered iPSCs (induced pluripotent stem cells), a process
that facilitates the robust expansion of uniform MSCs that
have higher potency, secrete higher levels of immunomodulatory
proteins, and offer practically unlimited supply.
"We believe Novellus's patented, non-immunogenic mRNA cell
reprogramming is clearly a superior methodology to generating MSCs
compared to the donor-derived model," said Myron Holubiak, Chief Executive Officer of
Citius. "The Novellus process provides a consistent cell bank
source, near unlimited supply, greater expansion potential with
comparatively less senescent cells. These early results from our
proof of concept study are encouraging and indicate potent action
which could lead to a treatment candidate for COVID-19 related
ARDS." Mr. Holubiak continued, "The development opportunities are
significant, and we believe our breakthrough i-MSC therapy
has the potential to be a strong catalyst for the advancement of
our business strategy."
About Citius Pharmaceuticals, Inc.
Citius is a late-stage specialty pharmaceutical company
dedicated to the development and commercialization of critical care
products, with a focus on anti-infectives and cancer care. For more
information, please visit www.citiuspharma.com.
About NoveCite iMSC (i-MSC)
NoveCite's mesenchymal stem cell therapy product is derived from
a human induced pluripotent stem cell (iPSC) line generated using a
proprietary mRNA-based (non-viral) reprogramming process. The
NC-i-MSCs produced from this clonal technique are
differentiated from human donor-derived MSCs (bone marrow,
placenta, umbilical cord, adipose tissue, or dental pulp) by
providing genetic homogeneity. In in
vitro studies, i-MSCs exhibit superior potency and
high cell viability. i-MSCs secrete immunomodulatory
proteins that may reduce or prevent pulmonary symptoms associated
with acute respiratory distress syndrome (ARDS) in patients with
COVID-19. The NoveCite i-MSC is an allogeneic (unrelated
donor) mesenchymal stem-cell product manufactured by expanding
material from a master cell bank.
First generation (human donor-derived) MSCs are isolated from
donated tissue followed by culture expansion. Since only a
relatively small number of cells are isolated from each donation,
first generation MSCs are increased by growing the cells in
culture. Unfortunately, these type of MSCs start to lose potency,
and ultimately become senescent. Each donation produces a limited
number of MSCs, so a continuous supply of new donors is needed to
produce commercial scale. The number and quality of MSCs that can
be isolated from different donors can vary substantially.
About Acute Respiratory Distress Syndrome (ARDS)
ARDS is an inflammatory process leading to build-up of fluid in
the lungs and respiratory failure. It can occur due to infection,
trauma and inhalation of noxious substances. ARDS accounts for
approximately 10% of all ICU admissions and almost 25% of patients
requiring mechanical ventilation. Survivors of ARDS are often left
with severe long-term illness and disability. ARDS is a
frequent complication of patients with COVID-19. ARDS is sometimes
initially diagnosed as pneumonia or pulmonary edema (fluid in the
lungs from heart disease). Symptoms of ARDS include shortness of
breath, rapid breathing and heart rate, chest pain (particularly
while inhaling), and bluish skin coloration. Among those who
survive ARDS, a decreased quality of life is relatively common.
Safe Harbor
This press release may contain "forward-looking statements"
within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. Such statements
are made based on our expectations and beliefs concerning future
events impacting Citius. You can identify these statements by the
fact that they use words such as "will," "anticipate," "estimate,"
"expect," "should," and "may" and other words and terms of similar
meaning or use of future dates. Forward-looking statements are
based on management's current expectations and are subject to risks
and uncertainties that could negatively affect our business,
operating results, financial condition and stock price.
Factors that could cause actual results to differ materially from
those currently anticipated are: the risks associated with
developing the NoveCite technology as a treatment for ARDS; risks
associated with developing any of our product candidates, including
that preclinical results may not be predictive of clinical results
and our ability to file an IND for such candidates; the estimated
markets for our product candidates, including those for ARDS, and
the acceptance thereof by any market; our need for
substantial additional funds; risks relating to the results of
research and development activities; uncertainties relating to
preclinical and clinical testing; the early stage of products under
development, including the NoveCite technology; our ability to
obtain, perform under and maintain licensing, financing and
strategic agreements and relationships; our ability to attract,
integrate, and retain key personnel; risks related to our growth
strategy; our ability to identify, acquire, close and integrate
product candidates and companies successfully and on a timely
basis; government regulation; patent and intellectual property
matters; competition; as well as other risks described in our SEC
filings. We expressly disclaim any obligation or undertaking to
release publicly any updates or revisions to any forward-looking
statements contained herein to reflect any change in our
expectations or any changes in events, conditions or circumstances
on which any such statement is based, except as required by
law.
Contact:
Andrew Scott
Vice President, Corporate Development
(O) 908-967-6677 x105
(M) 646-522-8410
ascott@citiuspharma.com
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SOURCE Citius Pharmaceuticals, Inc.