The limitations of current animal and in vitro cell culture testing have long been a stumbling block for pharmaceutical companies as they endeavor to develop new lifesaving drugs. A drug candidate that has shown great promise in preclinical development can come to a dead end in human trials due to unanticipated heart or liver toxicity or metabolism issues, costing pharmaceutical companies hundreds of millions of dollars they’ve invested in discovering, optimizing, and validating the potential efficacy of the drug candidate. However, one biotechnology company is working to remedy this problem by meeting the tremendous need for predictive toxicology screening systems with greater accuracy.
VistaGen Therapeutics is currently developing Human Clinical Trials in a Test Tube, a versatile new stem cell technology platform that will bring human biology to the forefront of drug development.
Human Clinical Trials in a Test Tube provides clinically relevant predictions of the potential toxicity of new drug candidates long before they ever reach human trials. Human biology can only be approximated by animal testing and other nonclinical techniques and technologies currently being used in drug development, but VistaGen’s human pluripotent stem cell-based bioassay systems are able to much more closely emulate human biology. Ultimately, the company’s revolutionary stem cell technology platform is expected to result in greater success for pharmaceutical companies and their drug candidates that have been stalled in human trials.
By overcoming the limitations of current testing methods, VistaGen hopes to enable pharmaceutical companies to recapture substantial value from their prior investments in drug candidates that were once promising. The company’s goal is to create, using its stem cell technology, a diverse pipeline of new proprietary small molecule variants (drug rescue variants) of small molecule drug candidates that once showed great potential but have been discontinued by pharmaceutical companies, the NIH, or academic laboratories due to heart or liver toxicity or metabolism concerns in humans. By focusing exclusively on these discontinued drug candidates that showed positive preclinical efficacy data, VistaGen believes it will capture a valuable advantage in its efforts to identify and develop new, safe drug rescue variants faster and more cost-effectively than companies that are discovering and developing drug candidates through conventional animal studies and in vitro cell culture testing systems.
Through Human Clinical Trials in a Test Tube, VistaGen and its medicinal chemistry partner will be able to focus drug rescue efforts on generating safer proprietary drug rescue variants and retaining the promising efficacy of discontinued drug candidates with reduced toxicity.
For more information about VistaGen and Human Clinical Trials in a Test Tube, visit www.VistaGen.com
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