Lixte Biotechnology and City of Hope enroll first patient in Phase 1b trial with lead compound LB-100 for the treatment of small cell lung cancer

  • Comprehensive preclinical data shows elevations in LB-100 the effectiveness of chemotherapy in animal models

  • Due to the aggressive progression of small cell lung cancer, It is possible that therapeutic benefit in patients May are seen in this early stage clinical trial

EAST SETAUKET, NY, June 02, 2021 (GLOBE NEWSWIRE) — Lixte Biotechnology Holdings, Inc. (Nasdaq: LIXT), a clinical drug discovery company developing pharmacologically active drugs for use in cancer treatment, today announced the enrollment of its first patient in a Phase 1b clinical trial with City of Hope, a world-renowned independent center for cancer research and treatment. The study will assess the combination of Lixte’s premium protein phosphatase 2A (PP2A) inhibitor LB-100 with a standard regimen for previously untreated, extensive stage disease small cell lung cancer (ED-SCLC) (NCT04560972).

John S. Kovach, MD, founder and chief executive officer of Lixte, said, “In partnership with City of Hope, we are pleased to pursue our well-founded rationale for adding LB-100 to a standard ED-SCLC regimen of carboplatin and etoposide chemotherapy plus atezolizumab to improve efficacy.In preclinical studies, the malignant cells of this uniformly lethal cancer are genetically sensitive to PP2A inhibition through a process called synthetic lethality, and the effectiveness of the standard regimen is enhanced by LB-100.

“Small cell lung cancer accounts for about 15% of all lung cancers worldwide with about 30,000 new cases per year in the US,” continued Dr. kovach. “The median survival of patients with this particularly aggressive form of lung cancer, even with the current ‘best’ therapy, is approximately nine months. Because of such rapid disease progression, the therapeutic benefit of adding LB-100 to standard treatment can be seen early in this Phase 1b clinical trial.”

Ravi Salgia, MD, Ph.D., City of Hope’s Arthur & Rosalie Kaplan Chair in Medical Oncology, said, “We are hopeful that this trial testing a potentially more effective therapeutic combination could provide another treatment option for small cell lung cancer patients. It is a disease that is currently difficult to treat, especially after a patient has relapsed, so more therapeutic options are needed.”

About the study

In the Phase 1b trial of LB-100 for the treatment of ED-SCLC, Lixte’s lead compound will be given in combination with carboplatin, etoposide and atezolizumab, an FDA-approved but marginally effective regimen, in previously untreated ED-SCLC. The dose of LB-100 will be increased with fixed doses of the 3-drug regimen to achieve a recommended phase 2 dose (RP2D). The number of patients will then be expanded to allow a total of 12 patients to be evaluated on the RP2D to confirm its safety and to seek objective evidence for potential therapeutic activity, as assessed by objective response rate, duration of overall response, progression-free survival and overall survival. The study opened in City of Hope in Duarte, California.

About City of Hope

City of Hope is an independent biomedical research and treatment center for cancer, diabetes and other life-threatening diseases. Founded in 1913, City of Hope is a leader in Bone marrow transplant and immunotherapy such as CAR T cell therapy. City of Hope’s translational research and personalized treatment protocols advance care around the world. Human synthetic insulin, monoclonal antibodies and numerous breakthrough anticancer drugs are based on technology developed in the institution. AccessHopeTMLaunched in 2019, , a wholly owned subsidiary, is committed to serving employers and their healthcare partners by providing access to City of Hope’s exceptional cancer expertise. City of Hope, a National Cancer Institute-designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, is ranked among the nation’s “best hospitals” for cancer by US News & World Report. The main campus is located near Los Angeles, with: additional locations throughout Southern California and in Arizona. For more information about City of Hope, follow us Facebook, Twitter, YouTube or Instagram.

About Lixte Biotechnology Holdings, Inc.

Lixte Biotechnology Holdings, Inc. (Nasdaq: LIXT), is a clinical-stage pharmaceutical company focused on discovering drugs for more effective treatments for many cancers and other serious common diseases. A major cause of cancer is defects in the switches that turn the biochemical pathways in cells on and off. Most cancer research of the past 30 years has focused on the “on” switches, as the “off” switches, especially the main “off” switch, protein phosphatase (PP2A), were believed to cause intolerable toxicity in patients . Lixte has made a breakthrough with its new, premium lead compound, PP2A inhibitor LB-100, by showing that it is easily tolerated by cancer patients at doses associated with anticancer activity. This innovative approach encourages cancer cells damaged by chemo or other cancer therapies to continue to replicate before the damage is repaired, leading to more efficient death and removal of those cells from the body. Lixte partners with leading medical institutions and leading academic research centers to advance the clinical development of its compounds. The LB-100 compound, of which Lixte has no competitors, is being tested in three cancer treatment clinical trials, along with others in preparation.

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 about the Company’s financial position, business strategy and other plans and objectives for future operations, and assumptions and predictions about future product demand, supply, production, costs, marketing and pricing factors are all forward-looking statements. These statements are generally accompanied by words such as “plan”, anticipate”, “believe”, “estimate”, “potential(s),”, “continue”, “forecast”, “forecast”, “plan” , “may,” “will,” “should,” “should,” “should,” “expect” or the negative of such terms or other similar terminology. The Company believes that the assumptions and expectations expressed in such forward-looking statements are made, are reasonable, based on the information available to the Company as of the date hereof, but the Company cannot guarantee that these assumptions and expectations will prove correct or that the Company will take any action the Company currently intends to take are inherently subject to known and unknown risks and uncertainties Actual results or experience may differ materially from those anticipated or expected in the forward-looking statements Factors that could cause or contribute Such differences include, but are not limited to, regulatory policies, available cash, research results, competition from other similar companies, and market and general economic factors. This discussion should be read in conjunction with the Company’s filings with the U.S. Securities and Exchange Commission at:

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General Phone: (631) 830-7092
Investor Phone: (888) 289-5533

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