LIXTE Biotechnology Reports First Spanish Site Activated to Begin Accrual of Patients for a Phase 1b/2 Clinical Trial of LIXTE's Lead Anti-Cancer Compound, LB-100, Added to Doxorubicin as First-Line Treatment of Advanced Soft Tissue Sarcoma
April 24 2023 - 8:30AM
LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT) (“LIXTE”) a
clinical-stage drug discovery company developing pharmacologically
active drugs for use in cancer treatment, announced that the
Spanish Sarcoma Research Group (Grupo Español de Investigación en
Sarcomas, or GEIS) completed its first site initiation visit in
preparation for the advanced soft tissue sarcoma (ASTS) clinical
trial at Fundación Jiménez Díaz University Hospital (Madrid).
Fundación Jiménez Díaz University Hospital is
the home base of Dr. Javier Martín-Broto, Coordinating Investigator
of the clinical trial, GEIS Co-Founder, and an internationally
recognized expert in sarcoma research and therapy. Three additional
GEIS-associated cancer research centers, located in Valencia,
Barcelona, and Madrid, Spain, are expected to be activated in the
near-term, with Phase 1b patient accrual planned to begin by
mid-May 2023.
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.
John S. Kovach, MD, Founder and CEO of LIXTE,
said, “We are very pleased to finally have an opportunity to test
whether LB-100 improves the treatment of ASTS. GEIS has been very
patient, having had to wait several months for various regulatory
approvals to introduce LB-100 into a European clinical trial
program. The fact that this trial design is still relevant attests
to the slow pace of finding better treatments for this
disease."
For a more complete description of the science
underlying the study developed by Dr. Martín-Broto and his
colleagues, please see:
LIXTE Biotechnology Announces Approval of a
Phase 1b/2 Randomized Trial of Doxorubicin +/-Lb-100 in Advanced
Soft Tissue Sarcomas to be Conducted by the Spanish Sarcoma
Group
The Spanish Sarcoma Group Will Lead a European
Consortium to Evaluate the Ability of Lixte Biotechnology Holdings’
LB-100 to Improve First Line Therapy for Advanced Soft Tissue
Sarcomas
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 Statements
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:PondelWilkinson Inc. Investor
Relationspwinvestor@pondel.comRoger Pondel: (310) 279-5965Laurie
Berman: (310) 279-5962info@lixte.comGeneral Phone: (631)
830-7092Investor Phone: (888) 289-5533
Lixte Biotechnology (NASDAQ:LIXT)
Historical Stock Chart
From Aug 2024 to Sep 2024
Lixte Biotechnology (NASDAQ:LIXT)
Historical Stock Chart
From Sep 2023 to Sep 2024