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."
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.
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SOURCE Cardax, Inc.
Released November 28, 2018