Nutraceuticals as Pharmaceuticals: Disruptive New Therapeutics from Cardax

By May 21, 2014 Management Insights

By Gilbert Rishton, Ph.D., Cardax Chief Science Officer

I accepted my position at Cardax as a seasoned veteran of the pharmaceutical industry. And, while my industry experience was indeed marked with satisfying projects, and even a successful drug launch with my former colleagues at Amgen, my most profound impression of modern drug development is in its epic failures. Particularly, the industry has failed to deliver the innovative new drugs that were to address society’s most dramatically unmet medical needs: The chronic and progressive age-related diseases including metabolic disease (liver disease, obesity, metabolic syndrome), arthritis, and neurodegeneration (cognitive decline and dementia).

Shock waves emanating from these decades-long drug development failures go way beyond balance sheets and patent cliffs. The persistent drumbeat of consolidation, with pharma mergers followed closely by R&D contraction and lab closures, makes the point quite dramatically that the pharmaceutical industry’s focus has shifted away from medical need and toward the near-term bottom line. In 2014, at a time when our aging society needs it most, the pharmaceutical industry has stepped back from the challenge of these most difficult and devastating diseases, choosing instead to focus on lower risk acute infectious diseases and cancer.  This ensures that our aging population will face a future of unmanageable lifelong progressive disease requiring expensive patient care and resulting in heavily burdened healthcare systems around the world.

There is a concise reasoning for this failure to address the most dramatically unmet medical needs. In the early 1990s a confluence of new technologies promised to make drug development a more rational and “targeted” endeavor. The human genome was being solved and the golden age of biotechnology had provided insight into genetic markers of disease. The new biotechnologies enabled the development of transgenic disease models and provided ready access to isolated protein “targets;” these being the enzymes and receptors that were to be our drug intervention points for countless diseases. Miniaturization and automation technologies enabled high-throughput screening of large chemical collections in cell-free assays. Biological testing now had become “targeted biochemical screening.” But, in the end, after the near global implementation of these “high-throughput screening” methods, the study of isolated enzymes and receptors in little plastic wells ultimately proved to have little to do with the diseases we were trying to treat. The target-driven new technologies had largely failed to produce safe and efficacious drug candidates. These same technologies had, along the way, replaced much of the good biology and good pharmacology that had previously existed as the backbone of our drug development programs. To be sure, there is currently a “back to the future” effort to restore classical biology and a holistic “phenotypic” drug development paradigm but, across the industry, it seems the damage has been done.

So, as today’s risk-averse pharmaceutical industry steps back from the most dramatically unmet medical needs, Cardax is actively pursuing a solution. We simply asked the question: Why are age-related diseases age-related? Our answer: Age-related systemic inflammation drives chronic age-related disease. The normal processes of aging are associated with gradually increasing oxidative stress and inflammation. This normal aging can be enjoyed in relative good health given good nutrition and properly functioning antioxidant responses in our various tissues and organs. But, a lack of redox balance in one or more organs can accelerate oxidative stress and progressive age-related systemic inflammation—leading to one or more of the chronic age-related diseases including liver disease, arthritis, and dementia. Herein lies the common mechanism underlying all of the age-related diseases and also, quite possibly, the key to chronic disease treatment and prevention.

Currently available medicines do not address the root cause of the chronic age-related diseases. The pharmaceutical industry’s paradigm for drug development and clinical testing is necessarily focused on “downstream” symptomology. The Cardax anti-inflammatory therapeutics, derived from natural nutrients with centuries of human exposure, impact the earliest “upstream” mechanisms of chronic disease and aim to normalize systemic inflammatory processes and slow or even halt disease progression before the appearance of severe symptoms and thereby lessen or perhaps even prevent the need for expensive patient care. For example, currently marketed drugs that treat one of the largest unmet medical needs, rheumatoid arthritis, focus on more advanced symptoms and a particular pathogenic biomarker known as TNF-alpha.  These treatments require patients seeking relief to inject anti-TNF agents with significant side-effects and yet still have global annual sales of about $28B.1 In contrast, Cardax’s first oral product, astaxanthin, addresses the mechanisms causing the pathological overproduction of TNF-alpha in the first place but without the side effects of these agents. Astaxanthin could, by regulating the “upstream” cellular processes that lead to pathological TNF-alpha overproduction, safely restore normal levels of TNF-alpha and treat these large patient populations therapeutically and perhaps even preventatively.

Cardax plans to continue its disruptive therapeutic approach.  We are planning Phase II clinical programs to demonstrate efficacy in multiple therapeutic areas including osteoarthritis, liver disease, metabolic syndrome and age-related cognitive decline. The Cardax product platform including astaxanthin and its various orally bioavailable formulations promises to deliver robust efficacy and superior safety to nutraceutical and pharmaceutical consumers in both the earliest and later stages of chronic age-related disease.  Given the current hesitancy of the pharmaceutical industry, it seems to me that Cardax is particularly well-positioned to carry out the mission to treat and prevent age-related chronic disease and thereby address the dramatically unmet medical needs of our time.

1 FirstWord Lists – Pharma’s 50 biggest selling drugs, March 2014: http://www.firstwordpharma.com/node/1194000

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