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Compound Platform Rationale
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Cardax Pharmaceuticals develops proprietary small molecule therapies for large unmet medical needs where oxidative stress and inflammation play important causative roles—including aging-related chronic disorders such as dyslipidemia, metabolic syndrome, arthritis, atherosclerosis, hepatitis, macular degeneration, prostate disease, and more.
Anti-inflammatory drugs typically have significant issues, including long-term side effects that limit their utility. In contrast, the Company's proprietary, synthetic, natural compound derivatives have an outstanding safety profile, are orally bioavailable, and tissue selective.
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Safety
Most drugs target highly specific biological enzymes or receptors such as COX-2, TNF-α, CCR2, etc. While these natural targets play a significant role in inflammation, they are also critical components of important biological pathways. With chronic use of these drugs, these pathways may not function normally—resulting in adverse events. Also, these treatments often negatively affect other crucial biological systems, creating additional side effects. The Company's proprietary compounds:
- Localize in the plasma, mitochondrial, and nuclear membranes;
- Scavenge or quench the unwanted initiators and perpetuators of inflammation—reactive oxygen and nitrogen species (ROS and RNS); and
- Decrease infections in animals; with
- No evidence of off-target effects (e.g. receptor or pathway).
As a result, the Company's compounds are inherently safer than most other anti-inflammatory treatments.
Mechanism of Action
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Location, location, location. Unlike other well-known anti-oxidants, the active metabolite of our lead proprietary compound completely spans plasma, mitochondrial, and nuclear membranes of the targeted tissue, stabilizing these membranes and reducing or preventing lipid peroxidation, including the oxidation of LDL (see Fig. 1).
Its localization as well as its anti-oxidant and related anti-inflammatory effects reduce the oxidative stress that initiates and/or perpetuates the chronic and pathological activation of a number of inflammatory pathways, including NF-KB, JNK, and others. These data may help explain why other well-known anti-oxidants, such as beta-carotene, Vitamin C, and Vitamin E have not had clinical success.
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Fig. 1 McNulty, et. al. Biochimica Biophys Acta. 2007;1768(1): 167-174
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Our Drugs vs Dietary Supplements
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Our drugs are proprietary modifications (or “prodrugs”) of powerful anti-oxidant/anti-inflammatory xanthophyll carotenoid compounds, usually found in esterified form in nature, that have evolved over millions of years. Like astaxanthin dietary supplements made from extracts of the microalgae Haematococcus Pluvialis, CDX-085 is comprised of astaxanthin esters but in a far purer form (>90% vs. 5%-16%). Despite the increased purity, however, CDX-085 costs substantially less than dietary supplements per mg of astaxanthin to produce and its production is cleaner and more sanitary.
Importantly, unlike dietary supplements, our drugs will go through the rigorous FDA process to prove safety and efficacy in human clinical trials with manufacturing purity/control, thereby providing doctors and patients with the assurance of the consistency, efficacy, and safety of an FDA approved drug.
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Fig. 2 The source of astaxanthin-containing dietary supplement is the microalgae Haematococcus Pluvialis which is grown in large open ponds, then concentrated by centrifugation and other methods (photo source: Nutrex Hawaii).
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