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Head-to-Head Data to Support Consumer Health Dose Selection
HONOLULU–(BUSINESS WIRE)–June 18, 2015–
Cardax, Inc. (“Cardax”) (OTCQB:CDXI) announced today that it initiated a single-dose pharmacokinetic study in non-human primates (monkeys) to compare the bioavailability (exposure) of CDX-085, the Company’s patented consumer health product candidate, to microalgal astaxanthin, the predominate astaxanthin consumer health form on the market.
Results are anticipated in July and will inform the selection of a consumer health dose based on the relative exposure of nature-identical astaxanthin following oral administration of CDX-085. CDX-085 has demonstrated oral bioavailability in multiple animal studies in different species (mice, rats, dogs, monkeys) but has not been tested head-to-head against microalgal astaxanthin. Cardax is targeting product launch in 2016 following GRAS designation.
Cardax believes that the current manufacturing capability of microalgal astaxanthin producers will not satisfy the growing demand for astaxanthin in human health applications and there is a need for synthetic production of bioavailable nature-identical astaxanthin products with high-purity, batch-to-batch consistency, and reliable large-volume supply at economical costs.
“We look forward to the results of this study,” said Cardax CEO, David G. Watumull. “It furthers a critical component of our development strategy.”
Cardax is a development stage life sciences company that devotes substantially all of its efforts to developing consumer health and pharmaceutical products that it believes will provide many of the anti-inflammatory benefits of steroids or NSAIDS by targeting many of the same inflammatory pathways and mediators, but with exceptional safety profiles. Cardax is preparing proprietary nature-identical products and related derivatives by total synthesis to provide scalable, pure, and economical therapies for diseases where inflammation and oxidative stress are strongly implicated, including, but not limited to, osteoarthritis, rheumatoid arthritis, dyslipidemia, metabolic disease, diabetes, cardiovascular disease, hepatitis, cognitive decline, macular degeneration, and prostate disease. The initial primary focus of Cardax is its astaxanthin technologies. Astaxanthin is a powerful and safe naturally occurring anti-inflammatory and anti-oxidant without the adverse side effects typical of anti-inflammatory treatments using steroids or NSAIDS, including immune system suppression, liver damage, cardiovascular disease risk, and gastrointestinal bleeding. The safety and efficacy of Cardax’s product candidates have not been directly evaluated in clinical trials or confirmed by the FDA.
This release may contain certain forward-looking statements regarding our prospective performance and strategies within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995, and are including this statement for purposes of said safe harbor provisions. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of our company, are generally identified by use of words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “project,” “seek,” “strive,” “try,” or future or conditional verbs such as “could,” “may,” “should,” “will,” “would,” or similar expressions. Our ability to predict results or the actual effects of our plans or strategies is inherently uncertain. Accordingly, actual results may differ materially from anticipated results. Some of the factors that could cause our actual results to differ from our expectations or beliefs include, without limitation, the risks discussed from time to time in our filings with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Except as required by applicable law or regulation, we undertake no obligation to update these forward-looking statements to reflect events or circumstances that occur after the date on which such statements were made.
Janice Kam, 1-808-457-1400
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