Full Press Release Details
Biotechnology Announces Sarah Cannon Research Institute Joins City of Hope's Ongoing Phase 1b Clinical Trial in Evaluating Lixte's
Lead Anti-Cancer Compound, LB-100, in Small Cell Lung Cancer
Trial Focuses on Assessing Whether LB-100 Enhances the Effectiveness of a Standard Regimen Combining Immunotherapy and Chemotherapy for
Untreated Small Cell Lung Cancer as it Does in Animal Models
CA, April 4, 2023 - LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT) ("LIXTE" or the "Company"),
a clinical-stage drug discovery company developing pharmacologically active drugs for use in cancer treatment, announced that Sarah Cannon
Research Institute (SCRI) ) at Tennessee Oncology in Nashville, Tennessee, is joining an ongoing Phase 1b clinical trial initiated at
City of Hope, one of the largest cancer research and treatment organizations in the United States, to assess the combination of LIXTE's
first-in-class protein phosphatase 2A (PP2A) inhibitor LB-100 with a standard regimen for previously untreated, extensive stage disease
small cell lung cancer (ED-SCLC) (NCT04560972).
of Hope continues as the coordinating center for the trial with Ravi Salgia, M.D., PhD, as the principal investigator. The SCRI component
of the trial will be led by Melissa Johnson, M.D. Drs. Salgia and Johnson are nationally recognized leaders in lung cancer research and
S. Kovach, M.D., LIXTE's founder and Chief Executive Officer, commented, "We are excited to have SCRI at Tennessee Oncology
joining this important clinical trial. The involvement of SCRI, one of the world's leading oncology research organizations, is
expected to increase the accrual of patients to this clinical trial, thus reducing the time required to demonstrate the feasibility,
tolerability, and efficacy of adding LB-100 to this regimen. If a significant improvement in outcome is seen with the addition of LB-100
to this regimen, this would be an important advance in the treatment of this very aggressive disease."
Salgia, M.D., Ph.D., City of Hope's Arthur & Rosalie Kaplan Chair in Medical Oncology, commented, "City of Hope is
pleased that this trial is continuing and will be accessible to more small cell lung cancer patients who are in need of more therapeutics
Johnson, M.D., Director, Lung Cancer Research, SCRI, commented, "Small cell lung cancer is a very aggressive cancer with few therapeutic
advances in recent years. We remain committed to identifying and advancing novel therapies for these patients. Dr. Salgia's protocol
adds Lixte's lead compound, LB-100, to both chemotherapy and immunotherapy in a promising new approach to this disease."
LIXTE Biotechnology Holdings, Inc.
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 with its novel, first-in-class lead clinical compound and PP2A
inhibitor, LB-100, demonstrating that 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.
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 U.S. and one of the leading research centers for diabetes
and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines, as
well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer
center at its core, City of Hope brings a uniquely integrated model to patients spanning cancer care, research and development, academics
and training, and innovation initiatives. City of Hope's growing national system includes its Los Angeles campus, a network of
clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta,
Chicago and Phoenix. City of Hope's affiliated group of organizations includes Translational Genomics Research Institute
Sarah Cannon Research Institute
Cannon Research Institute (SCRI) is one of the world's leading oncology research organizations conducting community-based clinical
trials. In 2022, SCRI formed a joint venture with US Oncology Research to enhance clinical trial access and availability across the country.
Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. It has conducted more
than 600 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer
therapies approved by the FDA today. SCRI's research network brings together physicians who are actively accruing patients to clinical
trials at more than 250 locations in 26 states across the United States.
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, and the patent and
legal costs to protect and maintain the Company's intellectual property worldwide, 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, research results, competition from other similar businesses, and market and general economic factors. This
discussion should be read in conjunction with the Company's filings with the United States Securities and Exchange Commission at
more information about LIXTE, Contact:
Phone: (631) 830-7092
Phone: (888) 289-5533
Inc. Investor Relations
Pondel: (310) 279-5965
Berman: (310) 279-5962