Lixte Biotechnology Announces Initiation of a Phase I Trial of Its Lead Anti-Cancer Compound, LB-100

EAST SETAUKET, N.Y., April 25, 2013 /PRNewswire/ -- Lixte Biotechnology Holdings, Inc. (LIXT), reported the start of a Phase I trial to determine the appropriate dose of its potentially first-in-class, anticancer compound, LB-100, when given alone and then when given in combination with docetaxel (Taxotere®). Details of the trial underway at an NCI-designated Comprehensive Cancer Center are available in the clinical trials registry: http://clinicaltrials.gov/show/NCT01837667.

Dr. John Kovach, the founder of Lixte said that "LB-100 inhibits an enzyme necessary for cancer cells to recover from damage to DNA. In mouse model systems of human cancers, LB-100 potentiates the activity of widely used anti-cancer regimens that exert their therapeutic benefit by damaging DNA without apparent increases in their toxicity. We hope the same benefit of the combination of LB-100 and known anti-cancer drugs will be seen in patients. In the present trial, LB-100 will be partnered with the versatile drug, docetaxel. As a single agent, docetaxel is the treatment of choice for several common cancers after failure of first-line therapy. Enhancement of the therapeutic benefit of docetaxel for these cancers is the initial goal in the clinical development of our novel DNA-repair disrupter."

About Lixte Biotechnology Holdings, Inc.

Lixte is a drug discovery company, using biomarker technology to identify enzyme targets associated with serious common diseases and then design novel compounds to attack those targets. Lixte is engaged primarily in development of improved treatments for cancer.

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 10K for December 31, 2012.

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

SOURCE Lixte Biotechnology Holdings, Inc.