Method for Pre-Determining and Reversing Toxicity of Drugs

Background Side effects and toxicity are a significant issue with many promising drugs. While a drug may remedy the targeted illness, serious side effects can, in some cases, be worse than the initial malady. In general, the side effects of a given drug are known, but may often be limited to a small subset of individuals. In such a subset, side effects may often be so severe that alternate therapies are required. In some instances, FDA approval can even be denied for an otherwise promising drug, if the side effects are severe.

Invention Description This University of Texas at Austin invention is a method that can test a substance's ability to ameliorate the toxic effects of a drug compound. It is a simple two-step process comprising: a) incubating lymphocytes in the presence of the compound and in the presence and absence of the substance; and b) comparing the toxic effect of the drug compound on the lymphocytes incubated in the presence of the substance to the effect of the drug compound on the lymphocytes in the absence of the substance. Compounds that can be addressed include drugs, food additives, herbs and herbal extracts, and other chemicals and biochemicals that are used by humans.

Benefits

The invention provides a reliable, safe, and effective means of identifying substances that can overcome, ameliorate, or at least reduce side effects, toxic effects, or sensitivities to different compounds that an individual may experience. Individual patients can be tested. The method allows for determination of toxicity before prescribing.

Features

Uses a simple blood sample to test for patient sensitivity and/or toxicity Tests a range of concentrations of a substance identified by the method of the invention to obtain the lowest possible dosage at which the substance can reverse the toxic effect of the compound Measures growth rate and the effect of a toxic compound on the cell size of lymphocytes

Market Potential/Applications Initial target market segments would include pharmaceutical manufacturers that must conduct phase testing of their pipeline drugs. Approximately 30% of drug applications are not successful, but they must still use testing apparatus and methods. Therefore, this is a multimillion-dollar market. With the additional application to individual prescriptions, this could increase into the billion-dollar range. (FDA, Center for Drug Evaluation and Research)

Development Stage Proof of concept

IP Status One U.S. patent issued: 6,723,527

UT Researcher William Shive, Ph.D., Chemistry, The University of Texas at Austin Flora H. Pettit, Ph.D., Chemistry and Biochemistry, The University of Texas at Austin


OTC Contact Information , Licensing Specialist

512-471-4919

Type of Offer: Licensing



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