Woulgan®Biogel available for professional wound and ulcer treatment in 2013
The company Biotec BetaGlucans AS in Tromsø, Norway, has developed a new product - Woulgan® Biogel – which effectively enhances the body’s own ability to heal wounds and ulcers, and which may shorten the treatment time for ulcers and slow-healing wounds.
There is a pressing need for more effective treatments of painful and often debilitating ulcers and slowly healing wounds, and today there are no medical products that effectively enhance the natural process of wound healing. The new product Woulgan® Biogel contains an active beta-glucan which enhances the body’s ability to produce new, healthy cell-tissue, while simultaneously enhancing mechanisms involved in removal of dead cells and repair of cell-damages in wounds and ulcers. Woulgan® Biogel is the result of the company’s basic research for very many years on chemistry and mode of action of the beta-glucan named SBG, followed by clinical studies with SBG, and during the last 2-3 years, final product formulation.
Woulgan® Biogel may reduce the severe pain and sufferings of people having chronic wounds and ulcers, and in addition reduce the very high monetary costs in the society as a whole of this debilitating condition. The risk of developing slow- and non-curable wounds increases with age of a person, and the risk is particularly high among diabetics since their natural wound healing ability is impaired. Diabetics are therefore at highest risk of developing chronic ulcers which may need lengthy and very expensive hospital treatments. Their wounds may in many cases become so serious that amputation becomes the only way out.
Western hospitals treat at least 16 million ulcer cases every year. The costs of such treatment amount to about 16 billion USD a year. The market today for advanced products like Woulgan® Biogel is estimated to be in the range of 5 billion USD. Woulgan® Biogel may serve a significant proportion of this market, since the product has notably better healing properties than hydrogel products used in wound management today – as documented in model studies with animals.
Woulgan® Biogel is a highly viscous fluid – a biogel – that can be applied directly onto wound or ulcer surfaces and covered with standard dressings. The product is unique in that it in addition to having moistening effect, like hydrogels, is supporting the healing process and hence may shorten the time to healing. The product was developed particularly for use on ulcers, and on wounds that will not grow by themselves.
Woulgan® Biogel contains glycerol, carboxymethylcellulose and 2% SBG in water. The product is sterile and contains no additives or preservatives. The company has applied for approval of the product as a medical device containing SBG as the medicinal component. This product category falls within Class III, Rule 13 of the EU regulation on medical devices.
Woulgan® Biogel is easy to use, has no side-effects and satisfies criteria for professional use in hospitals and medical centra. Since only a few specialized companies are the suppliers to this professional market, it will be most expedient to let Woulgan® Biogel be distributed by one or a few of those companies.
Woulgan® Biogel is suitable also for personal usage at home, because no special skills are needed for using the product against common problems like abrasions, blisters, minor burns, and cuts.
Woulgan® Biogel will be available in tubes containing 4 grams each, for use on individual patients. The biogel is to be applied onto dry or slightly running skin wounds, such as for instance diabetic ulcers, leg ulcers, graft and donor sites, post-operative surgical wounds, trauma wounds, 1st and 2nd degree burns, and abrasions and lacerations.
Model experiments using animals have shown that Woulgan® Biogel has good wound healing effects compared to hydrogels with established and recognized position in the wound healing market. SBG has previously been tested out in patients with diabetic leg ulcers, with good results.
SBG - the bioactive component in Woulgan® Biogel - is a solubilized (and patented) version of a beta-1,3/1,6-glucan present in baker’s yeast (S. cerevisiae). The compound combines many advantageous properties for medicinal usage. Animals and humans will “perceive” the chemical structure of SBG as being alien to the body, and when SBG comes in contact with immune cells, for instance in wounds, it will therefore elicit and enhance a number of natural defense and repair mechanisms. When macrophages - the body’s most important defense cells - interact with beta-glucan, they elicit a concerted action of tissue-repair mechanisms and prepare themselves for attacking and destroying intruding microbes.
It should be noted that there are many different types of beta-glucans in nature, with highly different properties. Only very few beta-glucans, however, have properties which make them relevant for use in modern medicinal products. Nevertheless, beta-glucans from mushrooms are often referred to as being the active component present in ”folk medicines” with a recognized position in ancient Oriental medicine.
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In 2011 Biotec Pharmacon ASA separated all assets related to its research on beta-glucans and development of beta-glucan products into its fully owned subsidiary Biotec BetaGlucans AS. Biotec Pharmacon ASA is listed on Oslo Børs in Norway (ticker: BIOTEC).
Biotec Pharmacon ASA started development of pharmaceutical products based on its own, patented soluble beta-glucan (SBG®) in 2000. A number of clinical trials with SBG were carried out in the period 2002 to 2010, among others clinical trials which resulted in an internationally patented method on using SBG to enhance the efficacy of monoclonal antibodies against cancer. Clinical application of SBG to treat diabetic ulcers got however, highest priority.
A phase II clinical trial on patients with diabetic foot and leg ulcers were completed with promising results. In the follow-up clinical phase III studies, however, SBG had lost its activity. The reason for this inactivation was a highly unexpected interaction between SBG and the plastic material in the packing, a packing material normally used for gel products. The company thus developed an improved formulation to stabilize the gel. This new product formulation opened to position the product as a medical device in Europe and the company decided on a new strategy to develop a new wound healing product. Woulgan® Biogel is the result of this change of strategy.
ArcticZymes AS is another subsidiary of Biotec Pharmacon ASA. The company develops, produces and sells cold adapted marine enzymes used in diagnostics and gene research.
Company contacts:
Chief scientific officer (CSO) Rolf Engstad: Telephone (+47) 959 41 542
CEO Svein Lien: Telephone (+47) 922 89 323
VP Finance & Administration Arvid Vangen: Telephone (+47) 950 38 794
Biotec BetaGlucans AS; Telephone (+47) 776 48 900
Sykehusveien 23, PO Box 6463, N-9294 Tromsø, Norway
More information: www.biotec.no