On January 19, 2021 Lixte Biotechnology Holdings, Inc. (NASDAQ: LIXT), a clinical-stage drug discovery company developing pharmacologically active drugs for use in cancer treatment, reported an agreement on a Phase 1b clinical trial with City of Hope, a world-renowned independent cancer research and treatment center (Press release, Lixte Biotechnology, JAN 19, 2021, View Source [SID1234574205]). 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).

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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."

Ravi Salgia, 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."