Resubmission to FDA planned for early
2024
CRANFORD, N.J., Sept. 8,
2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc.
("Citius" or the "Company") (Nasdaq: CTXR) is pleased to
announce the Company has received additional guidance from the U.S.
Food and Drug Administration (FDA) regarding the planned
resubmission of the Company's Biologics License Application (BLA)
for LYMPHIR™ (denileukin diftitox), an engineered
IL-2-diphtheria toxin fusion protein for the treatment of patients
with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after
at least one prior systemic therapy.
The FDA has agreed with the Company's plans to address the
requirements outlined in the complete response letter (CRL)
received July 28, 2023. The guidance
from the FDA provides Citius with a path for completing the
necessary activities to support the resubmission of the Company's
Biologics License Application (BLA) for denileukin diftitox. No
additional clinical efficacy or safety trials have been requested
by FDA for the resubmission.
"We are encouraged by the constructive engagement with the FDA,"
stated Leonard Mazur, Chairman and
CEO of Citius. "Based on the clear feedback from the FDA, Citius
plans to complete the CRL remediation activities by the end of the
year and file the resubmission in early 2024. We do not expect
these efforts will impact our cash runway."
About LYMPHIR™ (denileukin diftitox-cxdl)
LYMPHIR is a recombinant fusion protein that combines the
interleukin-2 (IL-2) receptor binding domain with diphtheria toxin
fragments. The agent specifically binds to IL-2 receptors on the
cell surface, causing diphtheria toxin fragments that have entered
cells to inhibit protein synthesis. In 2011 and 2013, the FDA
granted orphan drug designation to LYMPHIR for the treatment of
PTCL and CTCL, respectively. In 2021, denileukin diftitox received
regulatory approval in Japan for
the treatment of CTCL and peripheral T-cell lymphoma (PTCL).
Subsequently in 2021, Citius acquired an exclusive license with
rights to develop and commercialize LYMPHIR in all markets except
for Japan and certain parts of
Asia.
About Cutaneous T-cell Lymphoma
Cutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin
lymphoma (NHL) that comes in a variety of forms and is the most
common type of cutaneous lymphoma. In CTCL, T-cells, a type of
lymphocyte that plays a role in the immune system, become cancerous
and develop into skin lesions, leading to a decrease in the quality
of life of patients with this disease due to severe pain and
pruritus. Mycosis Fungoides (MF) and Sézary Syndrome (SS) comprise
the majority of CTCL cases. Depending on the type of CTCL, the
disease may progress slowly and can take anywhere from several
years to upwards of ten to potentially reach tumor stage. However,
once the disease reaches this stage, the cancer is highly malignant
and can spread to the lymph nodes and internal organs, resulting in
a poor prognosis. Given the duration of the disease, patients
typically cycle through multiple agents to control disease
progression. CTCL affects men twice as often as women and is
typically first diagnosed in patients between the ages of 50 and 60
years of age. Other than allogeneic stem cell transplantation, for
which only a small fraction of patients qualify, there is currently
no curative therapy for advanced CTCL.
About Citius Pharmaceuticals, Inc.
Citius is a late-stage biopharmaceutical company dedicated to
the development and commercialization of first-in-class critical
care products, with a focus on oncology, anti-infectives in adjunct
cancer care, unique prescription products, and stem cell therapies.
The Company's diversified pipeline includes two late-stage product
candidates, Mino-Lok®, an antibiotic lock solution for
the treatment of patients with catheter-related bloodstream
infections, which is currently enrolling patients in a Phase 3
Pivotal superiority trial, and LYMPHIR, a novel IL-2R immunotherapy
for an initial indication in
CTCL. Mino-Lok® was granted Fast Track
designation by the FDA. LYMPHIR has received orphan drug
designation by the FDA for the treatment of CTCL and PTCL. At the
end of March 2023, Citius completed
enrollment in its Phase 2b trial of
CITI-002, a topical formulation for the relief of hemorrhoids. For
more information, please visit www.citiuspharma.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 "believe," "anticipate,"
"estimate," "expect," "plan," "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 cost
and timing of the resubmission of the BLA for LYMPHIR; the FDA may
not approve our BLA for LYMPHIR; our need for substantial
additional funds; the estimated markets for our product candidates
and the acceptance thereof by any market; our ability to
commercialize our products if approved by the FDA; our dependence
on third-party suppliers; the ability of our product candidates to
impact the quality of life of our target patient populations; our
ability to successfully undertake and complete clinical and
non-clinical trials and the results from those trials for our
product candidates; risks relating to the results of research and
development activities, including those from existing and new
pipeline assets; uncertainties relating to preclinical and clinical
testing; the early stage of products under development; market and
other conditions; our ability to attract, integrate, and retain key
personnel; risks related to our growth strategy; patent and
intellectual property matters; 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 procure cGMP commercial-scale supply; government
regulation; competition; as well as other risks described in our
SEC filings. These risks have been and may be further impacted by
Covid-19. Accordingly, these forward-looking statements do not
constitute guarantees of future performance, and you are cautioned
not to place undue reliance on these forward-looking statements.
Risks regarding our business are described in detail in our
Securities and Exchange Commission ("SEC") filings which are
available on the SEC's website at www.sec.gov, including in our
Annual Report on Form 10-K for the year ended September 30, 2022, filed with the SEC on
December 22, 2022 and updated by our
subsequent filings with the SEC. These forward-looking statements
speak only as of the date hereof, and 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.
Investor Contact:
Ilanit Allen
ir@citiuspharma.com
908-967-6677 x113
Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com
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SOURCE Citius Pharmaceuticals, Inc.