Lixte Biotechnology's Lead Compound Lb-100 Reported To Enhance Chemotherapy Effectiveness In Animal Models Of Liver Cancer

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EAST SETAUKET, N.Y., June 18, 2014 /PRNewswire/ -- The journal Molecular Cancer Therapeutics has published an article on Lixte's lead compound LB-100 entitled "Inhibition of protein phosphatase 2A enhances cytotoxicity and accessibility of chemotherapeutic drugs to hepatocellular carcinomas." The article details a study showing that LB-100 increases the efficacy of two widely used anti-cancer drugs against liver cancers in model systems.

Performed at the Zhejiang University School of Medicine in Hangzhou, China, researchers reported that "LB-100 significantly enhanced inhibition of hepatocellular carcinoma (HCC) by doxorubicin and cisplatin in vitro and in vivo" and suggested that using LB-100 in combination with other drugs "may be a novel approach for enhancing the cytotoxic treatment of HCC and potentially other cancers."

John S. Kovach, M.D., President, Lixte Biotechnology Holdings, Inc. (LIXT.PK), commented on the study, "HCC is the most common cancer worldwide occurring primarily in individuals with underlying hepatitis B infection and is the third leading cause of all cancer-related deaths. While relatively uncommon in the US, the incidence of HCC appears to be increasing, most likely related to hepatitis C infection" (see more details at: http://www.cancer.gov/cancertopics/pdq/treatment/adult-primary-liver/HealthProfessional/page1).

Dr. Kovach noted, "Therapies for patients with advanced HCC have been relatively ineffective. Present standard treatment with a single drug, a protein kinase inhibitor, increases median survival of patients less than 3 months, from 7.9 months in patients receiving a placebo to 10.7 months without significant improvement in the median time to progression of symptoms due to the cancer. The Chinese investigators studied the ability of Lixte's compound, LB-100, to increase the efficacy of cisplatin or doxorubicin in animal models of HCC. Both of these drugs have been shown to have modest clinical activity in HCC patients but have not been associated with an increase in survival, the gold standard for determining anti-cancer treatment benefit."

"The potentiation of cisplatin or doxorubicin when combined with LB-100 in animal models of HCC without a significant increase in toxicity is encouraging," Dr. Kovach added. "The safety and toxicity of LB-100 in patients are currently under study in a Phase I trial in the USA. If LB-100 combined with cisplatin or doxorubicin is subsequently demonstrated to be safe in patients at concentrations which potentiate these drugs in animal models, we believe combination therapy with LB-100 will merit clinical evaluation in patients with advanced HCC, perhaps beginning with treatment of patients, who progress on standard chemotherapy."

An abstract of the article may be accessed at: http://mct.aacrjournals.org/content/early/2014/05/24/1535-7163.MCT-13-0800.abstract

About Lixte Biotechnology Holdings, Inc.

Lixte is a drug discovery company that uses biomarker technology to identify enzyme targets associated with serious common diseases and then design novel compounds to attack those targets. Lixte's product pipeline encompasses two major categories of compounds at various stages of pre-clinical and clinical development which the company believes have broad therapeutic potential not only for cancer but for other debilitating and life-threatening diseases. Lixte's unique phosphatase inhibitor, LB-100, is in a Phase I cancer trial at two NCI designated Comprehensive Cancer Centers (see ClinicalTrials.gov: Identifier NCTO1837667). For further discussion of the Lixte pipeline, go to: http://lixte.com/Nature_Biotechnology_2013_Lixte_Ad.pdf

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 condensed consolidated financial statements and notes thereto in the Annual Report on Form 10Q for September 30, 2013.

For additional information, please see: www.lixte.com

SOURCE Lixte Biotechnology Holdings, Inc.

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