Cardax, Inc. Launches Human Clinical Trial Targeting Cardiovascular Inflammatory Health
October 02, 2018 at 08:00 am EDT
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Cardax, Inc. has launched its Cardiovascular Health Astaxanthin Supplement Evaluation (CHASE) clinical trial targeting cardiovascular inflammatory health. The first subject was dosed on September 19, 2018. The randomized, double-blind, placebo-controlled CHASE clinical trial will evaluate the effect of low-dose and high-dose ZanthoSyn®, Cardax's premium astaxanthin supplement, on cardiovascular health, as measured by C-Reactive Protein (CRP) levels, over 12 weeks in up to 360 subjects with documented cardiovascular risk factors. The study will also include an optional open label extension through 48 weeks. Of the more than 50 human clinical trials conducted to date with various forms of astaxanthin, this pioneering study is believed to be the larger ever reported. The next three larger astaxanthin studies each had approximately 100 to 130 subjects and examined lower doses and/or shorter durations. The CHASE trial is expected to be more than 10 times the average reported astaxanthin clinical trial size of approximately 30 subjects. In addition to CRP as a primary endpoint, other markers of inflammatory health will be measured as exploratory endpoints in CHASE, including activation of FOXO3, the important anti-aging gene. Previous work with the University of Hawaii demonstrated that one of Cardax's astaxanthin compounds, CDX-085, activated FOXO3 in mammals (mice) for the first time. Extensive safety parameters will also be assessed. The trial is being conducted in Hawaii by Premier Medical Group (PMG), headed by Scott Miscovich, MD, the study's principal investigator, with the support of its Director of Clinical Research, Josh Green, MD. The unique structure of the collaboration between PMG and Cardax is expected to provide efficient recruitment of subjects and an economical cost structure consistent with the Company's resources and planned R&D expenditures.
Cardax, Inc. is a consumer health company focused on marketing ZanthoSyn, an astaxanthin dietary supplement for inflammatory health. It seeks to monetize CDX-101, the Company's pre-clinical pharmaceutical candidate for cardiovascular inflammation and dyslipidemia, and CDX-301, the Company's pre-clinical pharmaceutical candidate for macular degeneration. CDX-101 is a proprietary astaxanthin prodrug that cleaves following oral administration and delivers astaxanthin to the bloodstream. Astaxanthin is a naturally occurring molecule with safe anti-inflammatory activity that supports cardiovascular health, metabolic health, liver health, joint health, and longevity. It intends to develop zeaxanthin pharmaceutical candidate, CDX-301, for macular degeneration. Zeaxanthin accumulates in the human eye through uptake by a retinal receptor, providing protection against blue light, oxidative damage, and related inflammation that occurs in macular degeneration.