Fulhold Pharma is a UK-registered company which produces the patented CarboHydrate Derived Fulvic Acid (CHD-FA) and formulations containing this product. CHD-FA provides a new pharmaceutical platform technology with a wide range of applications in human and animal health. CHD-FA is a broad-spectrum anti-microbial/anti-inflammatory compound active on drug resistant Gram positive, Gram negative, and fungal pathogens that can be both ingested and topically applied safely. This powerful antimicrobial activity makes CHD-FA an effective agent in the fight against infection, including drug-resistant forms, in human and animal health and oral health applications.
In addition, CHD-FA in combination with lower levels of antibiotics has demonstrated the same efficacy as higher levels of the same antibiotics alone. This has the potential in both human and animal health to reduce the quantity (and therefore over-use) of antibiotics being taken whilst retaining equal efficacy. This also presents opportunities to extend the life (and therefore patents) of antibiotics which are or are becoming ineffective due to drug-resistance.
Founded as Ful Hold Ltd in 2002, Fulhold Pharma plc has a proven track record of the production and supply of pure CHD-FA together with a range of formulated products using CHD-FA as the platform technology. We hold a range of patents for the manufacture and use of CHD-FA in human and animal health applications.
We produce CHD-FA using a sustainable, environmentally-friendly technology and currently have two manufacturing plants, one in Stellenbosch in South Africa and the latest in Mauritius which was built to the same standards and production capacity as the original manufacturing plant in less than 100 days.
CHD-FA is a novel pharmaceutical platform technology and the base active ingredient in many current and planned formulations for the prevention or treatment of a wide variety of medical conditions.
CHD-FA is a safe, non-toxic, water soluble and heat stable ingredient that is manufactured to GMP standards. It is a new, pure, uniform version of an ancient natural ingredient – environmental fulvic acid. Environmental fulvic acid is derived from the microbial breakdown of plant and animal carbohydrate and has been present in the environment for millions of years.
CHD-FA, however, is a pure form of fulvic acid but without environmental contaminants such as heavy metals, herbicide and pesticide residues. It is therefore a safer and more effective form of fulvic acid than that sourced from the environment.
Re-usable evidence such as the proven safety and toxicity data means that CHD-FA can provide the platform technology for a wide range of applications at vastly reduced timeframes and cost.
Research & Development
This research has been carried out by a team of scientists at the New Jersey Medical School’s Public Health Research Institute (PHRI), led by Professor David Perlin and funded by the U.S. Congressionally Directed Medical Research Programs (CDMRP), which foster novel approaches to biomedical research in response to the expressed needs of its stakeholders- the American public, the U.S. military, and Congress.
It is our intention to develop and commercialise the use of CHD-FA in the treatment and/or prevention of wound infections, and the evidence base we have built through the PHRI research and other work makes this a compelling proposition in human and animal health, not just because of the demonstrable efficacy but that it could play a major role in the reduction of antibiotic use. Furthermore, as a safe and highly heat stable product, it has the potential to be deployed under a variety of field conditions.
Extensive research, primarily led by Professor Gordon Ramage, Infection and Immunity Research Group, Glasgow Dental School, University of Glasgow has shown that CHD-FA displays broad-spectrum activity against bacterial and fungal biomass, to similar levels as Chlorhexidine (CHX). CHD-FA is safe, organic and non-toxic to epithelial cells making it an attractive option for the development of a topical agent such a mouthwash or denture cleanser to treat microbial oral disease. We are currently developing both mouthwash and denture soak formulations (e.g. there is currently no effective topical antifungal agent in oral healthcare).
Both of these initiatives are critical to our strategy of focussing a large proportion of our R&D into high-value areas through the development of formulated products but also by establishing CHD-FA as a novel Platform Technology in those areas and attracting interest for further product development.
Mode of Action:
During 2015/2016, Fulhold sponsored a post-doctorate project with Dr Leighann Sherry, hosted by Professor Perlin, to attempt to discover the mode of action of CHD-FA against bacteria. The results are currently being analysed.
Testing against Xylella, a bug which is blighting the olive/olive oil industry, is currently underway
Our R&D activities also include areas such as Veterinary, Sports Nutrition, feminine hygiene, eczema, sanitizing and disinfectant formulations.
We are currently working with a Regulatory consultancy to create a series of dossiers with a view to seeking EU and FDA regulatory advice and achieving regulatory approvals for:
- a) CHD-FA as a chemical entity.
- b) A wound gel product.
- c) A mouthwash and/or other oral health products
We anticipate meeting the FDA and EMA in early 2017
Author: David Squire, March 2016