Cardax has dosed the first patient in its Cardiovascular Health Astaxanthin Supplement Evaluation (CHASE) clinical trial that aims to investigate the effect of ZanthoSyn for the treatment of cardiovascular inflammatory health.
The randomised, double-blind, placebo-controlled trial intends to analyse low-dose and high-dose ZanthoSyn on the basis of C-Reactive Protein (CRP) levels over a period of 12 weeks.
The trial is expected to enrol up to 360 subjects who showed cardiovascular risk factors.
Led by Scott Miscovich, the trial aims to include an optional open-label extension phase through 48 weeks.
The primary endpoint of the CHASE trial is measuring the CRP levels, while other exploratory endpoints include the activation of FOXO3, an important anti-ageing gene.
In addition, the trial, which is being performed in Hawaii by Premier Medical Group (PMG) under collaboration with Cardax, will evaluate various safety parameters.
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Cardax president and CEO David Watumull said: “This study is an important example of our commitment to the science underlying our products and if the results are positive, its well-controlled, scientifically credible design should provide a strong foundation for our future growth.”
The CHASE trial is based on the results of Canakinumab Anti-inflammatory Thrombosis Outcomes Study (CANTOS), which was sponsored by Novartis.
The trial demonstrated that reduction of CRP below 2mg/l led to a reduction of 25% in non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, as well as a 31% reduction in all-cause mortality.
It studied canakinumab, a monoclonal antibody targeting IL-1β, for the treatment of inflammation in cardiovascular health.
During the study, patients were also treated with standard of care, including statins, which did not bring any significant differences to the patient’s total cholesterol levels or other defined aspects of the study.