National Cancer Institute (NCI)-designated
research and treatment center City of Hope, in Duarte, CA, to participate in the University of Minnesota (UMN) Masonic Cancer
Center's ongoing Phase 1 trial to determine the maximum tolerated
dose of LYMPHIR plus CAR-T therapy
CRANFORD,
N.J., April 11, 2024 /PRNewswire/ -- Citius
Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a
late-stage biopharmaceutical company developing and commercializing
first-in-class critical care products, today announced that
the University of Minnesota Masonic
Cancer Center intends to expand their ongoing
investigator-initiated Phase 1 trial of LYMPHIR™ (denileukin
diftitox) in combination with FDA-approved CAR-T products for the
treatment of B-cell lymphomas. The ongoing study, led by Dr.
Veronika Bachanova at the University of
Minnesota (UMN), will include an additional study site at
City of Hope (COH), a world-renowned cancer treatment and research
institution, with Dr. Matthew Mei as
the principal site investigator at COH. City of Hope is one of only
53 National Cancer Institute (NCI)-designated comprehensive cancer
centers in the U.S.
"We are encouraged by the scientific community's
interest in exploring the potential benefits of LYMPHIR beyond
cutaneous T-cell lymphoma, for which a Biologics License
Application is currently under review by the FDA. We are very
excited to support UMN's expansion of its study to City of Hope as
distinguished oncologists Dr. Bachanova and Dr. Mei conduct
innovative research to evaluate LYMPHIR in combination with CAR-T
treatment," stated Dr. Myron
Czuczman, Chief Medical Officer of Citius. "This
first-of-its-kind study will evaluate the potential value that
transient depletion of T-regs within the tumor microenvironment by
LYMPHIR has upon CAR-T-based anti-tumor activity," added Dr.
Czuczman.
"This trial is designed to augment
lymphodepletion prior to CAR-T cells by administration of targeted
immunotoxin against IL-2 receptor-positive regulatory T-cells. The
lymphodepleting chemotherapy augmented with LYMPHIR was combined
with all three standard of care CAR-T products for diffuse large
B-cell lymphomas in second or third line of therapy. We look
forward to welcoming patients from City of Hope as we expand the
trial and evaluate the maximum tolerated dose," stated principal
investigator Veronika Bachanova, MD, PhD, Division of Hematology,
Oncology, and Transplantation, Department of Medicine, University of Minnesota.
Citius is collaborating with the University of Minnesota (UMN) in this
investigator-initiated study. This Phase 1 dose-finding study to
evaluate LYMPHIR prior to CAR-T therapies tisagenlecleucel
(KYMRIAH®), axicabtagene ciloleucel
(YESCARTA®), or lisocabtagene
maraleucel/BREYANZI®), in patients with B-cell lymphomas
(BCL) (NCT0485525) was initiated in May
2021 and has been expanded to include City of Hope.
Enrollment is underway for patients diagnosed with relapsed or
refractory BCL, for which treatment with CAR-Ts is planned, and who
are considered at high risk for progression after CAR-T
therapy.
About University of Minnesota
Masonic Cancer Center
The Masonic Cancer Center serves as the hub for cancer
research at the University of
Minnesota. More than 600 members apply their expertise to
the broad problem of cancer with research in cancer causes,
prevention, treatment, outcomes, and survivorship. Founded in 1991,
the cancer center became a National Cancer Institute (NCI)
designated Comprehensive Cancer Center in 1998, one of only 53
institutions in the United States
and two in Minnesota to hold that
designation.
About City of Hope
City of Hope, a National Cancer Institute
(NCI)-designated comprehensive cancer center, is a world-renowned
pioneer in cancer research, treatment and prevention. City of
Hope's mission is to deliver the cures of tomorrow to the people
who need them today. Founded in 1913, City of Hope has
grown into one of the largest cancer research and treatment
organizations in the U.S. and one of the leading research centers
for diabetes and other life-threatening illnesses. City of Hope
research has been the basis for numerous breakthrough cancer
medicines, as well as human synthetic insulin and monoclonal
antibodies. City of Hope brings a uniquely integrated model to
patients spanning cancer care, research and development, academics
and training, and innovation initiatives. City of Hope's growing
national system includes its Los
Angeles campus, a network of clinical care locations across
Southern California, a new cancer
center in Orange County,
California, and treatment facilities in Atlanta, Chicago and Phoenix. City of Hope's affiliated group of
organizations includes Translational Genomics Research
Institute and AccessHope™.
About Citius Pharmaceuticals, Inc.
Citius Pharma is a late-stage biopharmaceutical
company dedicated to the development and commercialization of
first-in-class critical care products. The Company's diversified
pipeline includes two late-stage product candidates. At the end of
2023, Citius completed enrollment in a Phase 3 pivotal superiority
trial of Mino-Lok®, an antibiotic lock solution to
salvage catheters in patients with catheter-related bloodstream
infections. Citius resubmitted the Biologics License Application
for LYMPHIR, a novel IL-2R immunotherapy for an initial indication
in cutaneous T-cell lymphoma, in early 2024, and announced plans to
form Citius Oncology, a standalone publicly traded company with
LYMPHIR as its primary asset. LYMPHIR received orphan drug
designation by the FDA for the treatment of CTCL and PTCL. In
addition, Citius completed enrollment in its Phase 2b trial of CITI-002 (Halo-Lido), a topical
formulation for the relief of hemorrhoids. For more information,
please visit www.citiuspharma.com.
Forward-Looking Statements
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," "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:
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; our need for substantial
additional funds; our ability to commercialize our products if
approved by the FDA; our dependence on third-party suppliers; our
ability to procure cGMP commercial-scale supply; the estimated
markets for our product candidates and the acceptance thereof by
any market; the ability of our product candidates to impact the
quality of life of our target patient populations; our ability to
obtain, perform under and maintain financing and strategic
agreements and relationships; 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 identify, acquire, close and integrate
product candidates and companies successfully and on a timely
basis; 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 and could be impacted by any future
public health risks. 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, 2023, filed with the SEC on
December 29, 2023, and updated by our
subsequent filings with the Securities and Exchange Commission.
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.
KYMRIAH® is a registered trademark of
Novartis Pharmaceuticals Corporation.
YESCARTA® is a registered trademark of
Kite Pharma, Inc., a Gilead Sciences, Inc. company.
BREYANZI® is a registered trademark of
Juno Therapeutics, Inc., a Bristol Myers Squibb company.
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.