Lixte Biotechnology and City of Hope to Initiate Phase 1b Clinical Trial of Lixte’s Lead Compound LB-100 to Treat Small Cell Lung Cancer

EAST SETAUKET, NY, Jan. 19, 2021 (GLOBE NEWSWIRE) -- . (NASDAQ: LIXT), a clinical-stage drug discovery company developing pharmacologically active drugs for use in cancer treatment, today announced an agreement on a Phase 1b clinical trial with , a world-renowned independent cancer research and treatment center. The trial will assess the combination of Lixte’s first-in-class protein phosphatase inhibitor LB-100 with a standard regimen for untreated, extensive stage-disease small cell lung cancer (ED-SCLC).

LB-100 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 escalated with fixed doses of the 3-drug regimen to reach a recommended Phase 2 dose (RP2D). Patient entry will then be expanded so that a total of 12 patients will be evaluable at the RP2D to confirm its safety and to look for objective evidence of potential therapeutic activity as assessed by objective response rate, duration of overall response, progression-free-survival and overall survival.

John S. Kovach, M.D., Lixte founder and chief executive officer, said “Small cell lung cancer (SCLC) comprises approximately 15% of all lung cancers worldwide with about 30,000 new cases annually in the US. Although this very aggressive neuroendocrine tumor is much more sensitive to cytotoxic chemotherapy and radiation than the most common type of lung cancer, SCLC patients soon relapse after treatment and have a dismal prognosis. Recently, the addition of an immune blocker, atezolizumab, to carboplatin plus etoposide showed the first significant but modest improvement in median progression free survival from 4.3 to 5.2 months, and in median overall survival from 10.3 to 12.3 months.”

Kovach continued, “In animal models, LB-100 significantly enhances the antitumor activity of cytotoxic chemotherapy in general, and in particular, the combination of carboplatin and etoposide against SCLC cells without enhancing toxicity. Mice models may not be predictive for humans, but if the extensive preclinical data showing LB-100 increases the effectiveness of chemotherapy applies to patients, we should see clear evidence of therapeutic benefit even in this early trial.”

, M.D., Ph.D., the trial’s principal investigator and City of Hope’s Arthur & Rosalie Kaplan Chair in Medical Oncology, said, “City of Hope is in constant pursuit of more effective therapies for its cancer patients, and this therapeutic combination could be one for patients with small cell lung cancer, which is currently difficult to treat, particularly after a patient has relapsed. We look forward to working with Lixte on this important trial that we hope will make more therapeutic options available for patients with small cell lung cancer.”

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  and immunotherapy such as . City of Hope’s translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin, monoclonal antibodies and  are based on technology developed at the institution. ^TM, a wholly owned subsidiary, was launched in 2019 and is dedicated to serving employers and their health care partners by providing access to City of Hope’s exceptional cancer expertise. A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nation’s “Best Hospitals” in cancer by U.S. News & World Report. Its main campus is located near Los Angeles, with  throughout Southern California and in Arizona. For more information about City of Hope, follow us on , ,  or .

About Lixte Biotechnology Holdings, Inc.

() is a clinical-stage pharmaceutical company dedicated to discovering drugs for more effective treatments for many forms of cancer and other serious common diseases. A major driver of cancer is defects in the switches that turn the biochemical pathways in cells on and off. Most cancer research over the past 30 years has focused on the “on” switches because the “off” switches, especially the master “off” switch protein phosphatase (PP2A), were believed to cause intolerable toxicity in patients. Lixte has achieved a breakthrough with its novel, first-in-class lead compound, PP2A inhibitor LB-100, by demonstrating that it is readily tolerated in cancer patients at doses associated with anti-cancer activity. This innovative approach encourages cancer cells, weakened by chemo or other cancer therapies, to continue to replicate, leading to the more efficient death and elimination of those cells from the body. Lixte has partnered with top medical institutions and leading academic research centers to advance the clinical development of its compounds. The LB-100 compound, of which there are no competitors in the clinic, is currently being tested in three clinical studies with others in planning.

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 product demand, supply, manufacturing, costs, marketing and pricing factors 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 .

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