CRANFORD, N.J., June 26, 2020 /PRNewswire/ -- Citius
Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a
specialty pharmaceutical company focused on developing and
commercializing critical care drug products, announced today that
the Company has received a written response from the U.S. Food and
Drug Administration (FDA) in regards to its pre-investigational new
drug (PIND) application for its induced mesenchymal stem cells
(iMSCs) to treat and reduce the severity of acute
respiratory distress syndrome (ARDS) in patients with COVID-19.
The FDA acknowledged that the Company could apply for fast track
designation and also provided Citius with the chemistry,
manufacturing, and control (CMC) requirements for the proposed
trials. The Company plans to initiate actions on the FDA's
recommendations and follow up with the FDA with an Investigational
New Drug (IND) application under the Coronavirus Treatment
Acceleration Program (CTAP).
Myron Holubiak, Chief Executive
Officer of Citius, commented, "We appreciate the FDA's thoughtful
guidance on our unique, allogenic mesenchymal stem cells derived
from induced pluripotent stem cells (iPSCs). We understand that
iPSC-derived stem cells are not the same as adult-donor derived
cells and, therefore, would require different proof of concept
studies. Since we believe in the advantages of iPSC MSCs over
donor-derived cells, we intend to develop assays recommended by the
FDA and demonstrate the safety of these MSCs in our preclinical
studies. We are committed to the successful completion of the
required clinical trials to provide an effective and safe therapy
for ARDS due to COVID-19."
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 Citius iMSC
Citius'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 iMSCs produced from
this clonal technique are differentiated from adult donor-derived
MSCs (bone marrow, placenta, umbilical cord, adipose tissue, or
dental pulp) by providing genetic homogeneity. In in-vitro studies,
iMSCs exhibit superior potency and high cell viability. The
iMSCs secrete immunomodulatory proteins that may reduce or
prevent pulmonary symptoms associated with acute respiratory
distress syndrome (ARDS) in patients with COVID-19. The Citius
iMSC is an allogeneic (unrelated donor) mesenchymal
stem-cell product manufactured by expanding material from a master
cell bank.
About Acute Respiratory Distress Syndrome (ARDS)
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 Coronavirus Treatment Acceleration Program
(CTAP)
In response to the pandemic, the FDA has created an
emergency program called the Coronavirus Treatment Acceleration
Program (CTAP) to accelerate the development of treatments for
COVID-19. By redeploying staff, the FDA is responding to
COVID-19-related requests and reviewing protocols within 24 hours
of receipt. The FDA said CTAP "uses every available method to move
new treatments to patients as quickly as possible, while at the
same time finding out whether they are helpful or harmful." In
practice, that means developers of potential treatments for
COVID-19 would benefit from an unusually faster track at the FDA to
shorten wait times at multiple steps of the process.
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 for a potential ARDS therapy with
Novellus, Inc. within the option period; the ability to access the
FDA's CTAP program for our planned ARDS therapy; risks associated
with developing our product candidates, including any licensed from
Novellus, Inc., including that preclinical results may not be
predictive of clinical results and our ability to file an IND for
such candidates; our need for substantial additional funds; risks
associated with conducting our Phase 3 trial for Mino-Lok,
including completing patient enrollment, opening study sites and
achieving the required number of catheter failure events; the
estimated markets for our product candidates, including those for
ARDS, and the acceptance thereof by any market; risks related to
our growth strategy; our ability to identify, acquire, close and
integrate product candidates and companies successfully and on a
timely basis; risks relating to the results of research and
development activities; uncertainties relating to preclinical and
clinical testing; the early stage of products under development;
our ability to obtain, perform under and maintain financing and
strategic agreements and relationships; 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 x105
ascott@citiuspharma.com
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SOURCE Citius Pharmaceuticals, Inc.