CRANFORD, N.J., April 1, 2020 /PRNewswire/ -- Citius
Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a
specialty pharmaceutical company focused on developing and
commercializing critical care drug products, today signed an
exclusive six-month option agreement to in-license a stem-cell
therapy for acute respiratory distress syndrome (ARDS) from a
subsidiary of Novellus, Inc., a preclinical-stage biotechnology
company based in Cambridge,
MA.
Novellus's patented process uses its exclusive non-immunogenic
synthetic messenger ribonucleic acid (mRNA) molecules to create
induced pluripotent stem cells (iPSCs) that, in turn, generate
mesenchymal stem cells (MSCs) with superior immunomodulatory
properties. MSCs have been shown to be safe in over 900 clinical
trials and to be safe and effective in treating a number of
inflammatory diseases, including ARDS.
"ARDS is the most common cause of respiratory failure and
mortality in COVID-19 patients. Currently, there is no proven
treatment for ARDS. Literature supports the use of
counter-inflammatory MSCs for ARDS, and papers published in
China have shown that at least
seven COVID-19 patients with ARDS responded to MSC therapy. Clearly
this is an avenue that shows promise and should be pursued as a
potential treatment for ARDS. We believe Novellus is at the
forefront of creating allogeneic, iPSC-derived MSCs. These cells
have the potential to overcome the limitations of MSCs derived from
adult donors, which are telomere shortened and introduce
variability into the manufacturing process," said Citius Chief
Executive Officer Myron
Holubiak.
Novellus Chief Science Officer Matt
Angel, PhD, stated, "Using our mRNA-based cell-reprogramming
technology, Novellus can provide a near-unlimited supply of MSCs
for treating patients with ARDS, including those critically ill
from COVID-19. These will be allogeneic ('off-the-shelf') cells
that in vitro have demonstrated much greater expansion
potential and much higher immunomodulatory protein expression than
donor-derived MSCs. We are excited to employ our technology to such
an urgent medical crisis and believe that our MSCs represent an
ideal source of cells to be used in this extremely important
development effort."
Holubiak added, "No effective pharmacotherapy for ARDS exists,
and ARDS-related morbidity and mortality are high. MSCs have been
studied in the treatment of lung injury, and we aim to build upon
this work with Novellus's iPSC-derived MSCs to improve the
immunomodulatory response in humans. We have assembled a team of
experts who are dedicated to advancing this project to an
Investigational New Drug (IND) application as quickly as
possible."
About ARDS
Acute respiratory distress syndrome (ARDS)
is a type of respiratory failure characterized by rapid onset of
widespread inflammation in the lungs. ARDS is a rapidly progressive
disease that occurs in critically ill patients – most notably now
in those diagnosed with COVID-19. ARDS affects approximately
200,000 patients per year in the U.S., exclusive of the current
COVID-19 pandemic, and has a 30% to 50% mortality rate. 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.
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 Novellus, Inc.
Novellus is a pre-clinical stage
biotechnology company developing engineered cellular medicines
using its non-immunogenic mRNA, nucleic-acid delivery, gene
editing, and cell reprogramming technologies. Novellus is privately
held and is headquartered in Cambridge,
MA. For more information, please visit
www.novellus-inc.com.
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 risk
of successfully negotiating a license agreement with Novellus
within the option period; our need for substantial additional
funds; the estimated markets for our product candidates, including
those for ARDS, and the acceptance thereof by any market; risks
associated with conducting trials for our product candidates,
including those expected to be required for any treatment for ARDS
and our Phase III trial for Mino-Lok; risks relating to the results
of research and development activities; risks associated with
developing our product candidates, including any licensed from
Novellus, including that preclinical results may not be predictive
of clinical results and our ability to file an IND for such
candidates; uncertainties relating to preclinical and clinical
testing; the early stage of products under development; risks
related to our growth strategy; our ability to obtain, perform
under, and maintain financing and strategic agreements and
relationships; our ability to identify, acquire, close, and
integrate product candidates and companies successfully and on a
timely basis; our ability to attract, integrate, and retain key
personnel; 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
ascott@citiuspharma.com
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SOURCE Citius Pharmaceuticals, Inc.