As presented in Part 1 there is compelling evidence for the testing of CHD-FA™ against the present coronavirus strain Covid-19. Fifteen years have passed since the original coronavirus testing and Fulhold Pharma Ltd has conducted further research and development during this time.
CHD-FA™ as far as we know, is the only fulvic acid in the world that is:
- Pure, no heavy metals, no toxins and chemical residues.
- The production process is consistent from batch to batch.
- The process can be easily scaled up to meet volume requirements.
- Is produced from a sustainable source.
- The production process is a green technology, the only by products being carbon dioxide and water.
- Has followed a typical pharmaceutical development program which is described below.
- Initial screening for efficacy
CHD-FA™ was initially screened for activity in vitro in four first world countries. The categories of screening were antibacterial, antifungal, antiviral, anti-inflammatory, type 2 diabetes and as a carrier of minerals into cells. This research is readily available to interested parties/ partners.
CHD-FA™ passed all tests in first world laboratories.
- Safety and toxicity testing
Pharmaceutical safety and toxicity testing was performed over a two-year period at a Good Laboratory Practice (GLP) facility in the UK and passed all tests to the highest standard. As far as is known, no other fulvic acid has been subjected to such testing, primarily as they suffer from contaminants and would fail.
- ADME testing
ADME stands for Adsorption, Distribution, Metabolism and Excretion of CHD-FA™ when both ingested and applied to the skin. The tests were performed at TNO in Holland in 2012. TNO is a respected government test facility based in Zeist.
The reason for these tests was to find out what happens to CHD-FA™ when ingested or applied to the skin in an animal model. All tests were passed. Further skin testing was then performed in Germany at DermaConsult using the skin patch test to check for skin safety in humans. The report concluded that CHD-FA™ is harmless when applied to the skin. This period of research resulted in the formation of a cosmetic company based on CHD-FA™ as the active ingredient.
- Humans ingested trials
Following successful safety and toxicity trials Fulhold undertook two human clinical trials for the ingested use of CHD-FA™.
The first study report was defined as: `A phase 1 clinical trial on the acute and sub-acute safety and proof of concept of CHD-FA™’.
The hypothesis was that CHD-FA™ was safe at the oral dosage tested and that CHD-FA™ demonstrated anti-inflammatory properties.
The study design was an investigational, single centre, randomized, double blind, placebo phase 1 safety study involving 30 subjects lasting 41 days.
The conclusion of the report stated: `No severe adverse events occurred, proving CHD-FA™ to be safe at the dosage tested, and with a significant decrease in wheal formation in the skin prick test, that CHD-FA™ acts as an anti-inflammatory agent. With all of the data from previous toxicity studies it can be stated with confidence that a daily dose of 15 ml CHD-FA™ diluted in water or juice, as recommended by the manufacturer, can be used safely for extended periods of time’.
This cannot be said for all other fulvic acids as they have not been subject to human clinical trials as they contain harmful contaminants.
The second study was a formulation of CHD-FA™ with selenium and L-glutamine which lasted 36 months with over 300 patients. The Investigational Drug Brochure Code was (FH0210).
Page 120 of the report concludes the following:
- CHD-FA™ is indicated as a complementary treatment for a broad spectrum of bacterial, viral and fungal conditions.
- No contraindications noted.
- No special warnings for use.
- No indication of interaction with other medicines.
- No trials on pregnant or lactating women have been conducted. Trials on pregnant animals have indicated no toxicity.
- CHD-FA™ has no narcotic effect.
- Occasional instances of diarrhoea and / or mild headache have been noted at the beginning of treatment. These have all disappeared after a day or two.
- No special first aid measures are required for inhalation, ingestion or skin contact.
- Contact with eyes or open wounds can cause stinging due to low pH. In such cases rinsing with water will relieve symptoms. Without rinsing the symptoms only last a few seconds.
- Safety trials up to 80 ml per day (administered as 40 ml twice per day) have noted no adverse effects.
CHD-FA™ is thus a safe candidate to advance to clinical trials in humans following successful in- vitro testing against coronavirus strain Covid-19.