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Novel Therapeutic Approaches to Treatment of Parasitic Disease and Related Clinical Conditions.
University of Kentucky Between 40 and 80% of all humans are infected with Toxoplasma gondii; in "healthy" adults, signs of infection are subtle, and include reduced IQ, reduced educational attainment and behavioral changes. There is a body of evidence that suggests a causative role for T. gondii in schizophrenia, and acute toxoplasmosis is difficult to distinguish clinically from schizophrenia. T. gondii readily produces clinical disease in AIDS or transplant patients, or early fetal life, where immune responses are reduced. T. gondii is an apicomplexan organism; and therefore very specifically and selectively inhibited by triazinone (dicalzuril) drugs. They have a highly specific mechanism of action, the mammalian toxicity is minimal, and they have long been used in prophylaxis/treatment of intestinal coccidiosis in animals and birds. We have established the therapeutic efficacy and low toxicity of diclazuril in the treatment of an equine myeloencephalitis (Equine Protozoal Myeloencephalitis, EPM) caused by an apicomplexan, S. Neurona. We obtained a patent (5,883,095, 1999) which is licensed to Bayer Animal Health; In 2001, Bayer Marquis®, toltrazuril sulfone, became the first FDA-approved treatment for EPM (http://www.yourhorseshealth.com/epm/treat.html). We propose to follow this Equine Protozoal Myeloencephalitis model by demonstrating the therapeutic efficacy of diclazuril and or related triazinones in animal models or clinical cases of schizophrenia or other human T. gondii disease(s), thereby reducing this concept to practice and enabling patenting. UK patent #5,883,095 above was licensed in State, and then sub-licensed to Bayer. The licensing fee was US $1,000,000 and annual royalties approach US$500,000; successful completion of this project could yield 100 times this income.
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