LIXTE Biotechnology and the Spanish Sarcoma Group Enroll First Patient in a Phase 1b/2 Randomized Trial of Doxorubicin +/- LIXTE’s Lead Anti-Cancer Compound, LB-100, in Advanced Soft Tissue Sarcomas
2023年6月7日 - 9:30PM
LIXTE Biotechnology Holdings, Inc.
(Nasdaq:
LIXT) (“LIXTE”), a clinical-stage drug discovery company developing
pharmacologically active drugs for use in cancer treatment, today
announced the enrollment of the first patient in the Phase 1b
portion of the Phase 1b/2 protocol (NCT05809830) to determine the
appropriate dose of LB-100 given with a standard dose of
doxorubicin. Once the dose is determined, a randomized Phase 2
study will be initiated seeking to gain evidence that the inclusion
of doxorubicin increases time to a progression and/or overall
survival of patients with advanced soft tissue sarcomas
(ASTS).
John S. Kovach, MD, LIXTE’s founder and Chief
Executive Officer, commented, “The Phase 1b portion of the clinical
trial to determine the recommended phase 2 dose (RP2D) is expected
to be completed within approximately nine months from commencement.
Subsequently, up to ten more clinical sites are expected to join
the international Phase 2 portion of the study to enter up to 150
patients, randomized to standard cytotoxic chemotherapy with
doxorubicin alone, versus doxorubicin plus LB-100. Given the lack
of effective first-line treatments for ASTS, this trial has been
designed to provide data expected to be sufficient to justify
proceeding to a Phase 3 comparative study.”
Dr. Javier Martin-Broto, sarcoma expert at the
Fundación Jiménez Díaz University Hospital, Madrid, Spain, the
principal investigator of the clinical trial, commented, “This
clinical trial offers innovative research in the sarcoma field
aiming to explore in the clinic a combination of doxorubicin and
LB-100, an inhibitor of PP2A, which has proved to be synergistic in
the preclinical setting. The Phase 1b part is starting now, while
deep investigations are being developed to search the most robust
predictive biomarkers for LB-100 activity in the sarcoma context.
Investigators of this trial are excited and hopeful, with the idea
of potentially improving the efficacy exhibited by doxorubicin
alone during its solo 40-year reign. We have 3 activated sites in
Spain right now and 3 additional sites will join the Phase 1b part
in the coming weeks.”
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.
About GEIS (Grupo Español
de Investigación en Sarcomas)
GEIS is a non-profit organization in Spain
engaged in the research, development and management of studies and
clinical trials for sarcomas. GEIS has a mission to ensure the best
healthcare to sarcoma patients by helping bring new treatments to
them through clinical research. GEIS has successfully partnered
with various institutions and companies to help bring new
treatments to patients with sarcomas. Through the group’s many
research projects it has created or participated in over the years,
it has made a significant impact in the global research effort to
better treat patients with sarcomas. For more
information: http://www.grupogeis.org.
Forward-Looking StatementsThis
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) 830-7092Investor Phone: (888)
289-5533
or
PondelWilkinson Inc. Investor
Relationspwinvestor@pondel.comRoger Pondel: (310) 279-5965Laurie
Berman: (310) 279-5962
Lixte Biotechnology (NASDAQ:LIXT)
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