Otsuka's OPC-14117 In Trials For Dementia

Otsuka's OPC-14117, a vitamin E derivative with free radical-scavenging properties, has been entered into a Phase I/II trial in the USA for the treatment of HIV dementia. The hypothesis behind using this agent in this indication is that HIV causes indirect injury to neurons by triggering a cascade of degenerative events, associated with oxidative damage, which are common to other neurodegenerative disorders.

The trial is the first to be carried out by the Dana Consortium on Therapy for HIV Dementia and Related Cognitive Disorders, which has been created with a $1.9 million, three-year award from the Charles A Dana Foundation to researchers from the University of Rochester, Johns Hopkins and the University of Columbia. Otsuka is donating the drug for the trial to Dana, but is not licensing the compound, and retains rights to all applications of OPC-14117. The company is also testing the drug in Phase II trials as a treatment for Huntington's and Parkinson's disease.

The Phase I/II study began in December 1994 and aims to enroll 25 patients in the later stages of HIV infection at each consortium site for 12 weeks of blinded therapy, followed by a 12-week open-label extension, reports the Pink Sheet. The target dose is 24mg. Patients will be monitored with neuropsychological tests and questionnaires. The consortium also hopes to expand trials to include other potential agents of value in HIV dementia, including an excitoxicity inhibitor and a cytokine inhibitor.