Cardax, Inc. (“Cardax”) (OTCQB:CDXI) and the University of Hawaii (“UH”) announced today that the National Institute on Aging (“NIA”), one of the federal government’s National Institutes of Health (“NIH”), has selected Cardax’s proprietary astaxanthin compound CDX-085 for its anti-aging Interventions Testing Program (“ITP”). Only 4-5 compounds per year are typically chosen by the NIA for this program.
This selection resulted from a proposal to the ITP submitted by UH faculty Bradley Willcox, M.D. and Richard Allsopp, Ph.D. that was given a “high priority” ranking by the NIA. Dr. Willcox is Professor and Director of Research at the Department of Geriatric Medicine, John A. Burns School of Medicine), University of Hawaii (“JABSOM”), Principal Investigator of the NIH-funded Kuakini Hawaii LIFESPAN and HEALTHSPAN Studies, and Cardax Scientific Advisory Board member. Dr. Allsopp is an Associate Professor at the Institute for Biogenesis Research at JABSOM.
Assuming pilot studies to confirm stability in mouse chow and bioavailability are successful, the NIA would begin studies with CDX-085 in 2018.
The ITP, according to Longevity Magazine, is the most rigorous aging research program in the U.S. It is funded by the NIA and conducted through cooperative agreement grants at the University of Michigan, the University of Texas Health Science Center at San Antonio, and Jackson Labs. Anti-aging research candidates selected for the NIA program (“ITP selectees”) are extensively screened and chosen by NIH for their potential impact on lifespan extension and their ability to delay disease and dysfunction in mice at different ages. ITP selectees are sourced from pharmaceuticals, nutraceuticals, foods, diets, dietary supplements, plant extracts, hormones, peptides, amino acids, chelators, redox agents, and other agents or mixtures of agents.
The ITP testing protocols provide sufficient statistical power to detect lifespan changes in the 10–15 percent range. In addition, ITP selectees are tested to determine if they have effects on a range of late-life traits, potentially including studies of immune function, hormonal and metabolic profiles, and behavioral outcomes. Priority consideration is given to ITP selectees that are easily obtainable, reasonably priced, and can be delivered in the diet (preferred) or water.
The NIA study would build upon research recently announced by the University of Hawaii and Cardax demonstrating the ability of CDX-085 to activate the important anti-aging gene FOXO3 in mice. CDX-085, like the Company’s first generation dietary supplement, ZanthoSyn™, delivers astaxanthin to the blood stream with optimal absorption and purity, but in a more concentrated form, allowing higher doses per capsule and improved dosing convenience.
“This is a game changer,” said Dr. Willcox. “Through its inclusion in the federally funded ITP program, CDX-085 has now been elevated to a select group of compounds that hold the most promise for potential anti-aging activity—compounds we hope will foster longer and healthier lives for aging Americans, and others around the world. This builds on a growing number of success stories for Cardax and CDX-085.” Dr. Willcox and Dr. Allsopp conducted the CDX-085/FOXO3 study, mentioned above, and will be working closely with the NIA during testing of CDX-085 through the ITP.
“We are excited that the NIA has recognized the potential of our astaxanthin compound CDX-085 in aging,” added David G. Watumull, Cardax CEO. “Selection by NIA into this important anti-aging research program underscores the company’s strategic approach. It also highlights the importance of the science-based business model we share with our retail partner, General Nutrition Corporation (“GNC”), and will help us extend the strong ZanthoSyn brand preference we see in Hawaii amongst the GNC sales staff, consumers, and physicians to other parts of the U.S.”
Cardax devotes substantially all of its efforts to developing and commercializing safe anti-inflammatory dietary supplements and drugs. Cardax is initially focusing on astaxanthin, which is a powerful and safe naturally occurring anti-inflammatory without the side effects of currently marketed anti-inflammatories. The safety and efficacy of Cardax's products have not been directly evaluated in clinical trials or confirmed by the FDA.
About the National Institute on Aging
The National Institute on Aging (NIA) is one of the federal government’s 27 institutes and centers of the National Institutes of Health (NIH), and leads a broad scientific effort to understand the nature of aging and to extend the healthy, active years of life. NIA, the leader in aging research, is also the primary Federal agency supporting and conducting Alzheimer's disease research.
CDX-085 is Cardax’s patented astaxanthin compound and is designed to deliver a highly concentrated form of astaxanthin to the bloodstream. The Company is developing CDX-085 initially as a dietary supplement and possibly later as an OTC drug. In monkey studies it was nearly 18x stronger than a leading microalgal astaxanthin dietary supplement.
ZanthoSyn™ is a physician recommended anti-inflammatory supplement for health and longevity that features astaxanthin with optimal absorption and purity. ZanthoSyn is sold online and in Hawaii GNC stores. ZanthoSyn contains astaxanthin, which is Generally Recognized as Safe (GRAS) according to FDA regulations.
Astaxanthin is a clinically studied compound with safe anti-inflammatory activity that supports joint health, cardiovascular health, metabolic health, liver health, and mental health.*
FOXO3 is a member of the forkhead family of transcription factors. The human homolog in C. elegans, daf-16, has profound effects on longevity (Kenyon et al. A C. elegans mutant that lives twice as long as wild type. Nature 1993). Scientists led by Dr. Bradley Willcox MD, member of the Cardax scientific advisory board, discovered a genetic variant of FOXO3 in humans that is strongly associated with longevity (Willcox et al. Proc US Natl Acad Sci 2008). This observation has since been replicated in >20 independent studies. The protective FOXO3 allele (SNP rs 2802292 – G allele) doubled the odds to live to 100 and two G alleles (GG genotype) tripled the odds to live to 100. The protective FOXO3 allele is strongly associated with reduced coronary heart disease mortality (p=0.00004)) and is also associated with reduced serum inflammatory markers (CRP and TNF-?) (Willcox et al. Aging Cell 2016; Willcox et al. J Gerontol Biol Med Sci 2017).
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