Cardax launches clinical trial of anti-inflammatory pill
Cardax Inc. has launched a clinical trial to evaluate the effect on cardiovascular health for low and high doses of its new anti-inflammatory product ZanthoSyn.
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Cardax Inc. has launched a clinical trial to evaluate the
effect on cardiovascular health for low and high doses of its new anti-inflammatory product ZanthoSyn.
The Honolulu-based company, which was due to announce today that the trial is underway, said it will be the largest
astaxanthin human clinical study ever conducted. The study of Cardax’s synthetic astaxanthin dietary supplement will be held over 12 weeks in up to 360 subjects with documented cardiovascular risk factors. The first subject began the trial on Sept. 19.
“This particular trial is designed to be a supplement trial and demonstrate the impact of ZanthoSyn on cardiovascular health as measured by C-Reactive Protein (CRP), which is a well-accepted marker of inflammatory activity,” Cardax President and CEO David Watumull said Monday in an interview. “This is definitely new for us. It’s a significant size trial and looking at important end points that have been demonstrated to have significant impact on cardiovascular health in major studies.”
Cardax said there have been more than 50 human clinical trials to date with various forms of astaxanthin. It said the next three largest astaxanthin studies each had about 100 to 130 subjects and examined lower doses and/or shorter
“If we can demonstrate ZanthoSyn’s impact on cardiovascular inflammatory health as measured by CRP, it would be
a strong endorsement of the value of ZanthoSyn as a dietary supplement,” Watumull said.
The Cardiovascular Health Astaxanthin Supplement Evaluation (CHASE) trial, which is taking place in Hawaii, is expected to be more than 10 times the average reported
astaxanthin clinical trial size of approximately 30 subjects.
“This study is an important example of our commitment
to the science underlying our products,” Watumull said in a statement. “And if the results are positive, its well-controlled, scientifically credible design should provide a strong foundation for our future growth.”
The CHASE medical monitor and trial design lead is Dr. Jon L. Ruckle, Cardax’s chief medical officer, who has extensive experience as principal investigator of more than 350 clinical trials at contract research organizations. The trial is being conducted in Hawaii by Premier Medical Group, headed by Dr. Scott Miscovich, the study’s principal investigator, with the support of Dr. Josh Green, its director of clinical research and the Democratic candidate for lieutenant governor.
Cardax has seen sales soar since launching ZanthoSyn in August 2016. It began selling its product to General Nutrition Corp. stores in Hawaii on Jan. 25, 2017, and GNC stores across the United States on Aug. 10, 2017. Cardax had $585,359 in sales through the first six months of this year, which was more than triple the $174,227 it generated during the same period in 2017.
Shares of Cardax closed unchanged at 20 cents on Monday. The stock is up 25 percent this year.