LIXTE Adds Northwestern University’s Lurie Cancer Center as Second Site in Ongoing Clinical Trial for Ovarian Clear Cell Cancer
LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT) has expanded its clinical trial for ovarian clear cell cancer by adding the Robert H. Lurie Comprehensive Cancer Center of Northwestern University as a second site. The trial combines LIXTE's proprietary compound LB-100 with GSK's immunotherapy Dostarlimab.
Dr. Emily M. Hinchcliff will lead the trial at Lurie Cancer Center, where patient recruitment is underway and the first patient has already been dosed. This expansion follows the trial's initial launch in January 2024 at The University of Texas MD Anderson Cancer Center under lead investigator Dr. Amir Jazaeri.
The clinical trial aims to determine if adding LB-100 to Dostarlimab enhances immunotherapy effectiveness in treating ovarian clear cell carcinoma, which represents a disease with high unmet medical needs.
LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT) ha ampliato il suo studio clinico per il cancro ovarico a cellule chiare aggiungendo il Robert H. Lurie Comprehensive Cancer Center della Northwestern University come secondo sito. Lo studio combina il composto proprietario di LIXTE, LB-100, con l'immunoterapia di GSK, Dostarlimab.
La Dr.ssa Emily M. Hinchcliff guiderà lo studio presso il Lurie Cancer Center, dove è in corso il reclutamento dei pazienti e il primo paziente ha già ricevuto il trattamento. Questa espansione segue il lancio iniziale dello studio a gennaio 2024 presso il The University of Texas MD Anderson Cancer Center sotto la direzione del ricercatore principale, il Dr. Amir Jazaeri.
Lo studio clinico ha l'obiettivo di determinare se l'aggiunta di LB-100 a Dostarlimab migliori l'efficacia dell'immunoterapia nel trattamento del carcinoma ovarico a cellule chiare, che rappresenta una malattia con elevate esigenze mediche insoddisfatte.
LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT) ha ampliado su ensayo clínico para el cáncer de ovario de células claras al agregar el Robert H. Lurie Comprehensive Cancer Center de la Universidad Northwestern como segundo sitio. El ensayo combina el compuesto propietario de LIXTE, LB-100, con la inmunoterapia de GSK, Dostarlimab.
La Dra. Emily M. Hinchcliff liderará el ensayo en el Lurie Cancer Center, donde se está llevando a cabo el reclutamiento de pacientes y el primer paciente ya ha sido tratado. Esta expansión sigue al lanzamiento inicial del ensayo en enero de 2024 en el The University of Texas MD Anderson Cancer Center bajo la dirección del investigador principal, el Dr. Amir Jazaeri.
El ensayo clínico tiene como objetivo determinar si la adición de LB-100 a Dostarlimab mejora la efectividad de la inmunoterapia en el tratamiento del carcinoma de ovario de células claras, que representa una enfermedad con altas necesidades médicas insatisfechas.
LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT)는 난소 투명 세포 암에 대한 임상 시험을 확장하여 Northwestern University의 Robert H. Lurie Comprehensive Cancer Center를 두 번째 사이트로 추가했습니다. 이 시험은 LIXTE의 독점 화합물 LB-100과 GSK의 면역 요법 Dostarlimab를 결합합니다.
Emily M. Hinchcliff 박사가 Lurie Cancer Center에서 시험을 이끌며, 현재 환자 모집이 진행 중이고 첫 번째 환자가 이미 치료를 받았습니다. 이 확장은 2024년 1월에 Texas MD Anderson Cancer Center에서 Amir Jazaeri 박사가 주도한 시험의 초기 출시를 따릅니다.
임상 시험의 목표는 LB-100을 Dostarlimab에 추가함으로써 난소 투명 세포 암 치료에 있어 면역 요법의 효과를 향상시키는지 여부를 확인하는 것입니다. 이 질병은 높은 의료적 필요가 있는 상태입니다.
LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT) a élargi son essai clinique pour le cancer ovarien à cellules claires en ajoutant le Robert H. Lurie Comprehensive Cancer Center de l'Université Northwestern comme deuxième site. L'essai combine le composé propriétaire de LIXTE, LB-100, avec l'immunothérapie de GSK, Dostarlimab.
La Dr. Emily M. Hinchcliff dirigera l'essai au Lurie Cancer Center, où le recrutement des patients est en cours et le premier patient a déjà été traité. Cette expansion fait suite au lancement initial de l'essai en janvier 2024 au The University of Texas MD Anderson Cancer Center sous la direction du chercheur principal, le Dr. Amir Jazaeri.
L'essai clinique vise à déterminer si l'ajout de LB-100 à Dostarlimab améliore l'efficacité de l'immunothérapie dans le traitement du carcinome ovarien à cellules claires, qui représente une maladie avec de grands besoins médicaux non satisfaits.
LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT) hat seine klinische Studie für ovariales klarzelliges Karzinom erweitert, indem das Robert H. Lurie Comprehensive Cancer Center der Northwestern University als zweiter Standort hinzugefügt wurde. Die Studie kombiniert die proprietäre Verbindung von LIXTE, LB-100, mit der Immuntherapie von GSK, Dostarlimab.
Dr. Emily M. Hinchcliff wird die Studie im Lurie Cancer Center leiten, wo die Rekrutierung von Patienten bereits läuft und der erste Patient bereits behandelt wurde. Diese Erweiterung folgt dem ursprünglichen Start der Studie im Januar 2024 am The University of Texas MD Anderson Cancer Center unter der Leitung des Hauptforschers Dr. Amir Jazaeri.
Die klinische Studie zielt darauf ab, zu bestimmen, ob die Hinzufügung von LB-100 zu Dostarlimab die Wirksamkeit der Immuntherapie bei der Behandlung von ovarialem klarzelligem Karzinom erhöht, das eine Krankheit mit hohen unerfüllten medizinischen Bedürfnissen darstellt.
- Clinical trial expansion to a second prestigious site (Northwestern University's Lurie Cancer Center)
- First patient already dosed at the new site
- Partnership with GSK for combination therapy testing
- Addressing high unmet medical need in ovarian clear cell carcinoma
- Trial led by expert physicians at renowned cancer centers
- Early-stage clinical trial with uncertain outcomes
- No efficacy data reported yet
Insights
LIXTE's addition of Northwestern University's Lurie Cancer Center as a second clinical trial site represents meaningful progress in their development of LB-100 for ovarian clear cell carcinoma (OCCC). This expansion beyond MD Anderson Cancer Center should accelerate patient recruitment for this difficult-to-treat cancer subtype that accounts for approximately 5-10% of all ovarian cancers but has disproportionately poor outcomes with conventional treatments.
The scientific approach here deserves attention. LB-100, LIXTE's lead compound, is a first-in-class protein phosphatase 2A (PP2A) inhibitor that has shown potential to enhance the effectiveness of immunotherapies by modulating immune checkpoints and increasing tumor susceptibility. Its combination with GSK's Dostarlimab—an FDA-approved PD-1 inhibitor—represents a rational strategy to potentially overcome the immunosuppressive microenvironment that has immunotherapy success in OCCC.
For a micro-cap biotech with resources, securing two prestigious NCI-designated cancer centers signals investigator confidence in the scientific premise. The involvement of recognized clinical investigators like Dr. Jazaeri (MD Anderson) and Dr. Hinchcliff (Northwestern) adds credibility to the program.
While this news doesn't guarantee clinical success, it does suggest operational momentum. Investors should monitor several upcoming catalysts:
- Initial safety data from this Phase 1/2 trial
- Preliminary efficacy signals in this treatment-resistant population
- Potential expansion to additional trial sites
- Updates on patient enrollment rates
From a competitive standpoint, OCCC has few targeted treatment options, creating significant commercial potential if efficacy is demonstrated. However, LIXTE faces substantial financial constraints with its $3.4 million market cap, raising questions about funding through trial completion without additional capital raises.
This development represents a positive operational milestone that advances LIXTE's clinical program, though substantial clinical and financial hurdles remain before potential commercialization.
-- Lurie Cancer Center Completes Dosing of First Patient with LIXTE’s LB-100
in Combination with GSK’s Immunotherapy Dostarlimab --
PASADENA, CALIF., Feb. 25, 2025 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. (“LIXTE” or the “Company”) (Nasdaq: LIXT and LIXTW), a clinical stage pharmaceutical company, today announced it has added the Robert H. Lurie Comprehensive Cancer Center (Lurie Cancer Center) of Northwestern University as a second site in a clinical trial combining the Company’s proprietary compound LB-100 with GSK’s Dostarlimab to treat ovarian clear cell cancer.
Emily M. Hinchcliff, MD, MPH, will lead the clinical trial at Lurie Cancer Center, a renown Chicago-based National Cancer Institute-designated Comprehensive Cancer Center, which is located at Northwestern Memorial Hospital’s downtown medical campus. Patient recruitment is underway, and the first patient has been dosed.
“Clinical trials testing potentially effective therapies are essential to move our field forward, with many recent great successes,” said Dr. Hinchcliff. “We are pleased to be participating in this important clinical trial to assess whether adding LIXTE’s LB-100 to GSK’s Dostarlimab will enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma, a disease of high unmet need.”
Bas van der Baan, LIXTE’s Chief Executive Officer, said, “The addition of Lurie Cancer Center is a positive step in expanding the patient population and accelerating this clinical trial, which was initiated in January 2024 at The University of Texas MD Anderson Cancer Center. The trial is directed by lead clinical investigator Amir Jazaeri, MD, Professor of Gynecologic Oncology.”
About LIXTE Biotechnology Holdings, Inc.
LIXTE Biotechnology Holdings, Inc. is a clinical-stage pharmaceutical company focused on new targets for cancer drug development and developing and commercializing cancer therapies. LIXTE has demonstrated that its first-in-class lead clinical PP2A inhibitor, LB-100, is well-tolerated in cancer patients at doses associated with anti-cancer activity. Based on extensive published preclinical data, LB-100 has the potential to significantly improve outcomes for patients undergoing various chemotherapies or immunotherapies. LIXTE's new approach has no known competitors and is covered by a comprehensive patent portfolio. Proof-of-concept clinical trials are in progress. LB-100 is part of a pioneering effort in an entirely new field of cancer biology – activation lethality – that is advancing a new treatment paradigm. Additional information about LIXTE can be found at www.lixte.com.
Forward-Looking Statement Disclaimer
This announcement contains certain 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. For example, statements regarding the Company's financial position, business strategy and other plans and objectives for future operations, and assumptions and predictions about future activities, including the continuing development of proprietary compounds, the planning, funding, coordination and potential results of clinical trials, the patent and legal costs to protect and maintain the Company's intellectual property worldwide, and the Company’s ability to obtain and maintain compliance with Nasdaq’s continued listing requirements, are all forward-looking statements. These statements are generally accompanied by words such as "intend," anticipate," "believe," "estimate," "potential(ly)," "continue," "forecast," "predict," "plan," "may," "will," "could," "would," "should," "expect" or the negative of such terms or other comparable terminology.
The Company believes that the assumptions and expectations reflected in such forward-looking statements are reasonable, based on information available to it on the date hereof, but the Company cannot provide assurances that these assumptions and expectations will prove to have been correct or that the Company will take any action that the Company may presently be planning. However, these forward-looking statements are inherently subject to known and unknown risks and uncertainties. Actual results or experience may differ materially from those expected or anticipated in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, regulatory policies, available cash resources, research results, competition from other similar businesses, and market and general economic factors.
Readers are urged to read the risk factors set forth in the Company’s filings with the United States Securities and Exchange Commission at https://www.sec.gov. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For more information about LIXTE, contact: info@lixte.com
General Phone: (631) 830-7092; Investor Phone: (888) 289-5533
or
PondelWilkinson Inc. Investor Relations
pwinvestor@pondel.com
Roger Pondel: (310) 279-5965; Laurie Berman: (310) 279-5962
FAQ
What is the purpose of LIXTE's clinical trial for ovarian clear cell cancer?
When did LIXT begin its ovarian clear cell cancer clinical trial?
Who is leading LIXT's clinical trial at Northwestern University?
What compounds are being tested in LIXT's ovarian cancer trial?
Has LIXT begun dosing patients at the Lurie Cancer Center site?
