National Cancer Institute (NCI)-designated research and treatment center City of Hope, in
"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
"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
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
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
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
KYMRIAH ® is a registered trademark of Novartis (LON:0QLR) (SIX:NOVN) Pharmaceuticals Corporation.
YESCARTA ® is a registered trademark of Kite Pharma, Inc., a Gilead Sciences, Inc. (NASDAQ:GILD) company.
BREYANZI ® is a registered trademark of Juno Therapeutics, Inc., a Bristol Myers (NYSE:BMY) Squibb company.
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