On June 3, 2021 Lixte Biotechnology Holdings, Inc. (Nasdaq: LIXT), a clinical-stage drug discovery company developing pharmacologically active drugs for use in cancer treatment, reported the enrollment of the first patient in a Phase 1b clinical trial with City of Hope, a world-renowned independent cancer research and treatment center (Press release, Lixte Biotechnology, JUN 3, 2021, View Source [SID1234583455]). The trial will 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).
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John S. Kovach, M.D., Lixte founder and chief executive officer, said, "In collaboration with City of Hope, we are eager to pursue our well-grounded rationale for adding LB-100 to a standard ED-SCLC regimen of carboplatin and etoposide chemotherapy plus atezolizumab to enhance effectiveness. In preclinical studies, the malignant cells of this uniformly fatal cancer are genetically sensitive to PP2A inhibition by a process termed synthetic lethality and the effectiveness of the standard regimen is enhanced by LB-100.
"Small cell lung cancer comprises approximately 15% of all lung cancers worldwide with about 30,000 new cases annually in the U.S.," Dr. Kovach continued. "The median survival of patients with this especially aggressive type of lung cancer, even with current ‘best’ therapy, is approximately nine months. Because of such rapid disease progression, the therapeutic benefit of adding LB-100 to the standard treatment may be seen early on in this Phase 1b clinical trial."
Ravi Salgia, M.D., 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, particularly 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 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. The study is open at City of Hope in Duarte, California.