Cardax, Inc. Announces CHASE Clinical Trial Initiated- Rx Development Plans for CDX-101 and CDX-301
March 28, 2019 at 08:00 am EDT
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Cardax, Inc. announced that the Company's double-blind, randomized, placebo controlled, CHASE clinical trial was initiated in September 2018 and is currently enrolling subjects. The clinical trial is evaluating the effect of low-dose and high-dose ZanthoSyn® on cardiovascular inflammatory health, as measured by high sensitivity C-Reactive Protein (hsCRP), over 12 weeks in subjects with documented cardiovascular risk factors. The study will also include an optional open label extension through 48 weeks. Positive results from this clinical trial, if achieved, could help to: Drive scientific and consumer awareness of ZanthoSyn®'s health benefits. Support additional patent filings. Serve as proof of concept for astaxanthin Rx program. The Company's pharmaceutical development plans for CDX-101 and CDX-301 are underway: CDX-101 is being developed for cardiovascular inflammation and dyslipidemia. The Company believes that an initial indication of severe hypertriglyceridemia provides an efficient clinical pathway to drug approval for CDX-101. CDX-101 is currently in pre-clinical development, including the planning of IND enabling studies. An Investigational New Drug, or IND, must be submitted to the FDA and become effective before clinical trials with a pharmaceutical candidate can begin.CDX-301 is being developed for macular degeneration. The Company believes that an initial indication of Stargardt disease (juvenile macular degeneration) provides an efficient clinical pathway to drug approval for CDX-301.
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.