Pre-Specified Interim Review Demonstrated Beneficial Changes in Markers of Cardiovascular Health

– CRP, LDL, total cholesterol, triglycerides, oxidized LDL, and blood pressure reduced

– Interim results support excellent safety profile

– Enrollment continues

Cardax, Inc. (OTCQB: CDXI) today announced results from the pre-specified interim review of its ongoing CHASE (Cardiovascular Health Astaxanthin Supplement Evaluation) clinical trial.

The CHASE clinical trial is a double-blind, randomized, placebo-controlled clinical trial evaluating the effect of the Company’s astaxanthin dietary supplement ZanthoSyn®, on cardiovascular health, as measured by C-Reactive Protein or “CRP” levels over 12 weeks in up to 120 subjects with documented cardiovascular risk factors. Pre-specified secondary cardiovascular/inflammatory health markers, safety parameters, exploratory endpoints, and pre-specified sub-groups are also being assessed. The trial also includes an optional open-label extension through 48 weeks.

The interim results were based on data from 40 subjects administered high dose ZanthoSyn® (96 mg/day astaxanthin—48 mg twice a day), low dose ZanthoSyn® (24 mg/day astaxanthin—12 mg twice a day), or placebo. The Company believes these findings provide:

• Further mechanistic support for the Company’s astaxanthin pharmaceutical development program
• Basis for additional patent filings
• Support for the cardiovascular health benefits of ZanthoSyn*

“We are encouraged by the pleiotropic effects and excellent safety demonstrated in this interim review,” said Paresh Soni, M.D., Ph.D., the Company’s Chief Clinical and Regulatory Strategist. “We are continuing enrollment and look forward to the final results.”

Highlights from the interim review shown below are median percentage changes from baseline to week 12 unless otherwise stated. While the interim review was not powered for statistical significance, p-values less than 0.05 compared to placebo are provided.

• CRP: 28% decrease (high dose), 32% decrease (low dose), 5% decrease (placebo)
• Low-density lipoprotein cholesterol (LDL-C): 12% decrease (high dose), 7% decrease (low dose), 5% increase (placebo) (p<0.01 high dose)
• Total cholesterol: 8% decrease (high dose), 5% decrease (low dose), 4% increase (placebo) (p<0.05 high dose)
• Triglycerides: 16% decrease (high dose), 13% decrease (low dose), 6% increase (placebo)
• Oxidized LDL: 10% decrease (high dose), 3% increase (low dose), 4% increase (placebo) (p<0.05 high dose)
• Diastolic blood pressure: 5% decrease (high dose), 4% decrease (low dose), 6% increase (placebo) (p<0.05 high dose and p<0.05 low dose)
• Median astaxanthin blood levels at 12 weeks: 2,184 ng/mL (high dose), 790 ng/mL (low dose), below quantification limit of 10 ng/mL (placebo)

The interim results also underscore astaxanthin’s safety profile with no safety signals observed. The CHASE Data Safety Review Board recommended that the clinical trial continue enrollment.

“These cardiovascular health findings are promising and we are grateful to all the study participants and study staff for their hard work and dedication,” added David G. Watumull, Cardax President and CEO.

About Cardax
Cardax is a development stage biopharmaceutical company primarily focused on the development of pharmaceuticals for chronic diseases driven by inflammation. The Company also has a commercial business unit that markets ZanthoSyn®, a physician recommended astaxanthin dietary supplement for inflammatory health.* CDX-101, the Company’s astaxanthin pharmaceutical candidate, is being developed for cardiovascular inflammation and dyslipidemia, with a target initial indication of severe hypertriglyceridemia. CDX-301, the Company’s zeaxanthin pharmaceutical candidate, is being developed for macular degeneration, with a target initial indication of Stargardt disease. The Company’s pharmaceutical candidates are currently in pre-clinical development, including the planning of IND enabling studies. The safety and efficacy of the Company’s pharmaceutical candidates have not been directly evaluated in clinical trials or confirmed by the FDA.

Media and Investors
Janice Kam
1-808-457-1400
[email protected]