Method for Pre-Determining and Reversing Toxicity of Drugs

Introduction

Side effects and toxicity are a significant issue with many promising drugs. While a drug may remedy the targeted illness, the 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. FDA approval may even be denied for an otherwise promising drug, where the side effects are very severe in only a small subset of patients.

Invention Description

This method 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 experienceIndividual patients can be tested
• Allows for determination of toxicity before prescribing

Features

• Uses a simple blood sample to test for patient sensitivity and/or toxicity
• Multiple embodiments of the method may include: a) incubating the lymphocytes with a compound with a known toxicity in the presence of a substance known to reverse the known toxicity; and b) analyzing the effect on lymphocytes
• Testing 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
• Measuring growth rate and the effect of a toxic compound on the cell size of lymphocytes

Market Potential/Applications

Initially, market potential will concern pharmaceutical manufacturers that must conduct phase testing of their pipeline drugs. Since calendar year 1998, there were about 380 new and generic U.S. drug approvals. As of July 13, 2003, there were 46 new U.S. drug approvals. 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. (Source: FDA, Center for Drug Evaluation and Research, http://www.fda.gov/cder)

IP Status

U.S. Patent issued: 6,723,527
PCT Application filed

UT Researcher

• Flora H. Pettit, Ph.D., Biochemistry Department, The University of Texas at Austin
  
• Gwyn Shive, Biochemistry Department, The University of Texas at Austi
  
• William Shive, Ph.D., (deceased), Biochemistry Department, The University of Texas at Austin

For further information please contact:

University of Texas,
Austin, USA
Website : www.otc.utexas.edu