Lixte Biotechnology Holdings, Inc. (OTCQB: LIXT) announced the opening of a pharmacologic study of the ability of its lead clinical compound, LB-100, to enter the brain and penetrate recurrent glioblastoma multiforme tumors in patients in which surgical removal of their cancers is indicated (clinical trials registry: NCT03027388). The study is being conducted by the National Cancer Institute under a Cooperative Research and Development Agreement (CRADA) with Lixte.

Dr. John S. Kovach, founder and CEO of Lixte, said, “Glioblastoma brain tumors (GBMs) are very challenging to treat. Radiation combined with the chemotherapeutic drug, temozolomide has been the mainstay of GBM therapy for decades with some further benefit gained by the addition of one or more anti-cancer drugs but without major advances in overall survival for the majority of patients. In animal models of GBM, Lixte’s novel protein phosphatase inhibitor, LB-100, enhances the effectiveness of radiation, temozolomide chemotherapy treatments and immunotherapy, raising the possibility that LB-100 may improve outcomes of standard GBM treatment in the clinic. Although LB-100 has proven safe in patients at doses associated with apparent anti-tumor activity against several human cancers arising outside the brain, the ability of LB-100 to penetrate tumor tissue arising in the brain is not known. Unfortunately, many drugs potentially useful for GBM treatment do not enter the brain in amounts necessary for anti-cancer action.

The NCI study is designed to determine the extent to which LB-100 enters recurrent GBMs and related brain tumors. Patients having surgery to remove one or more tumors will receive one dose of LB-100 prior to surgery and have blood and tumor tissue analyzed for the amount of LB-100 present and to determine whether the cells in the tumors show the biochemical changes expected to be present if LB-100 reaches its molecular target. The goal is to obtain data in up to eight patients. Thanks to the innovative design of the NCI study, data from so few patients should be sufficient to provide a sound rationale for a conducting a larger clinical trial to determine the effectiveness of adding LB-100 to the standard treatment regimen for GBMs.”

For patients interested in enrolling in this clinical study, please contact NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615) and/or the Web site: https://trials.cancer.gov.

About Lixte Biotechnology Holdings, Inc.

Lixte is a biotech company that identifies enzyme targets associated with serious common diseases and then designs novel compounds to attack those targets. Lixte’s product pipeline is primarily focused on inhibitors of protein phosphatases, used alone and in combination with cytotoxic agents and/or X-ray and immune checkpoint blockers.