Cardax Names Former Amarin Head of Development Paresh N. Soni, MD, PhD, to lead Clinical and Regulatory Strategy
HONOLULU, Nov. 28, 2018 /PRNewswire/ -- Cardax, Inc. (OTCQB: CDXI) announced that Paresh N. Soni, M.D., Ph.D., the former Senior Vice President and Head of Development for Amarin Corporation, will join Cardax as Chief Clinical and Regulatory Strategist and as a member of the Company's Scientific Advisory Board. Dr. Soni will guide clinical and regulatory strategy for Cardax's pharmaceutical platform, interact with the FDA, and advise the Company on a full range of development issues.
As Head of Development at Amarin, Dr. Soni led the development of Amarin's clinical trial and regulatory strategy for its natural product fish oil drug Vascepa, including its MARINE, ANCHOR, and REDUCE-IT clinical studies. Vascepa was approved by the FDA for reduction of triglycerides in adult patients with severe hypertriglyceridemia. Amarin recently reported that the large REDUCE-IT trial met its primary endpoint, demonstrating an approximately 25% relative risk reduction to a high degree of statistical significance (p<0.001) in major adverse CV events (MACE) in the intent-to-treat patient population with use of Vascepa 4 grams/day as compared to placebo.
"We have long thought that natural products with pleiotropic mechanisms of action can safely address unmet medical needs in chronic disease," said Cardax CEO David G. Watumull. "Dr. Soni's work at Amarin helped to validate this approach and we are delighted to be working with him."
Dr. Soni added, "Cardax has the opportunity to create significant value from its pharmaceutical platform and I look forward to using my skillset and expertise to help steer their clinical and regulatory pathway."
About Cardax
Cardax—headquartered in Honolulu, HI—develops and commercializes innovative dietary supplements and pharmaceuticals. Cardax is initially focusing on astaxanthin, which is a powerful and safe naturally occurring anti-inflammatory for: 1) health and longevity as a dietary supplement; and 2) pleiotropic anti-inflammatory and lipid benefits as a drug candidate. The safety and efficacy of Cardax's products have not been directly evaluated in clinical trials or confirmed by the FDA.
Media Contact
Janice Kam
press@cardaxpharma.com
1-808-457-1400
Safe Harbor
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.
View original content to download multimedia:http://www.prnewswire.com/news-releases/cardax-names-former-amarin-head-of-development-paresh-n-soni-md-phd-to-lead-clinical-and-regulatory-strategy-300757210.html
SOURCE Cardax, Inc.
Released November 28, 2018