LIXTE Biotechnology Announces a Supported Collaborative Trial to Study LIXTE’s First-in-Class PP2A Inhibitor, LB-100, Plus GSK’s Immunotherapy, Dostarlimab, in Clear-Cell Ovarian Cancer
20 Setembro 2023 - 9:30AM
LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT) (“LIXTE”), today
announced a Phase 1b collaborative clinical trial to assess whether
adding Lixte’s LB-100 to GSK’s programmed death receptor-1
(PD-1)-blocking monoclonal antibody, dostarlimab, may enhance the
effectiveness of immunotherapy in the treatment of ovarian clear
cell carcinoma (OCCC). The clinical trial is sponsored by The
University of Texas - MD Anderson Cancer Center and will be
conducted at MD Anderson and will also be open at Northwestern
University’s Robert H. Lurie Comprehensive Cancer Center. LIXTE
will provide LB-100; GSK will provide dostarlimab and financial
support for the clinical trial.
The clinical trial is based on the observation
of longer survival of patients with OCCC treated with immunotherapy
whose cancer cells have an acquired gene mutation resulting in a
reduction in PP2A. This finding was reported by the lead clinical
investigators of this new trial1: Amir Jazaeri MD, Professor of
Gynecologic Oncology at MD Anderson, and Emily Hinchcliff, MD, MPH,
Assistant Professor of Obstetrics and Gynecology at Northwestern
University Feinberg School of Medicine. The observation by Drs.
Jazaeri and Hinchcliff, that a genetically acquired reduction in
PP2A enhances sensitivity to immunotherapy, raises the possibility
that reducing PP2A pharmacologically with LB-100 will enhance the
anti-tumor effect of the PD-1 blocking monoclonal antibody
dostarlimab in patients with OCCC lacking the genetic reduction in
PP2A.
John S. Kovach, M.D., LIXTE’s founder and Chief
Executive Officer, said, “Preclinical data supports the idea that
LB-100 enhances the efficacy of PD-1 therapy.1 Clinical data also
supports this idea, in that patients with ovarian clear cell
carcinoma with dysfunctional PP2A due to somatic mutations in
PPP2R1A have shown dramatically longer survival after treatment
with immune checkpoint blockers.”
Dr. Hinchcliff, said, “OCCC is a comparatively
chemotherapy resistant disease and therefore has very limited
options for treatment. This clinical trial is an exciting
alternative approach that leverages the potential synergy between
these two agents and is aiming to improve the impact immunotherapy
may have for these patients.”
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 achieved a breakthrough demonstrating 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
(see www.lixte.com), 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. Initial
proof-of-concept clinical trials are in progress.
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.comGeneral Phone: (631) 830-7092; Investor Phone: (888)
289-5533
or
PondelWilkinson Inc. Investor
Relationspwinvestor@pondel.comRoger Pondel: (310) 279-5965; Laurie
Berman: (310) 279-5962
1 Hinchcliff EM, Patel A,
Fellman B, Westin SN, Sood A, Soliman P, Shafer A, Meyer L, Fleming
N, Bathala Y, Ganeshan D, Hwu P, Lu K, Jazaeri A.
Loss-of-function mutations in PPP2R1A Correlate with Exceptional
Survival in Ovarian Clear Cell Carcinomas Treated with Immune
Checkpoint Inhibitors. National oral presentation at SGO Annual
Meeting, March 2022
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