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Dr Richard Robson was the investigator for our Phase I program. Each single and multiple ascending dose group consisted of 8 subjects, 6 were randomized to MitoQ® and 2 received placebo.
Our target in Phase I was to produce MitoQ® plasma levels in the ng/ml range and this was achieved. From animal studies we can correlate such levels with effective tissue and mitochondrial concentrations of MitoQ®. The results of this study confirmed that the doses for the Phase II studies.
The Phase II clinical efficacy study of MitoQ® began in May, 2006, and enrollment was completed in October, 2006. The Principal Investigator is Dr Barry Snow, Head of the Department of Neurology, Auckland Hospital. Enrolling sites are from both New Zealand and Australia. The study demonstrated the long term safety of MitoQ® in elderly patients.
This single-center 28-day Phase II trial, conducted in New Zealand, was initiated in February, 2007, to study liver disease in 30 patients who are chronically infected with Hepatitis C virus. The Principal Investigator for this study is Dr. Edward Gane, Associate Professor of Medicine, Auckland Hospital.
Information on clinical trial enrollment is available through this website under the Clinical Trial Info page.
Antipodean consults with Pacific BioDevelopment LLC, Burlingame, CA and maintains an office in Auckland, NZ for the management and monitoring of clinical trials.
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