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Microbial Glyco 23 is a new a class of membrane-derived glycolipids that have wide-ranging potential in clinical practice. We have demonstrated that Glyco 23 possesses remarkable protective effect, in terms of survival, anti-inflammatory and anti-necrotic activity in sepsis. Compelling preclinical survival and histological data was obtained from lung, liver and kidney, as well as cytokine profiles in small animals. In vivo experiments indicate that both intraperitoneal and intravenous injection of natural and select Glyco 23 components during cecal ligation, in puncture and endotoxin (galactosamine-LPS model)-induced rodent sepsis models, have a protective effect against the morbidity of systemic sepsis; and that these protective effects persist when sophorolipids are administered during and after the sepsis insult. In vitro experiments indicate that Glyco 23 derivatives and mixtures have immunomodulatory characteristics after exposure to lipopolysaccharide, specifically by decreasing production of pro-inflammatory cytokines. Furthermore, Glyco 23 affects other important anti-inflammatory immune responses, including regulation of cell surface adhesion molecule expression, and the ability to exert antimicrobial effects.

About Sepsis
Sepsis is widely regarded as the most challenging problem in intensive care, a direct consequence of the complexity of the disease, and heterogeneity of the patient population. It is a rapidly progressing disease with up to 80% associated mortality. Disease management is predominantly non-specific, relying on a range of interventions. Current diagnostics fail to allow for rapid and accurate diagnosis. Incidence of sepsis continues to rise across the developed world, with US increases of 1.5% per annum expected until 2020. Over 7 million people annually become susceptible to sepsis, and 250,000 Americans die from sepsis each year. Severe sepsis has an annual incidence exceeding three quarters of a million cases, a 28.6% overall hospital mortality rate, and an average cost of $22,100 per case,. Total annual costs for severe sepsis were estimated to be $16.7 billion.
The rate of sepsis due to fungal organisms increased by 207 percent; with gram-positive bacteria becoming the predominant pathogen after 1987. Rising disease incidence has been fueled by the growing number of surgical interventions, and an increase in immunocompromization.

Strategic Advantage
Glyco 23 has two fundamental advantages over competitors: Minimal toxicity and low cost. While activated protein C-as well as several of the above-mentioned technologies, as of yet not completely understood-has a narrow use and high price point, which limit sales; Glyco 23 would be recommended with almost no contraindications; and could be marketed at a very affordable cost. It is clear that price reduction may lead to wider use, and provide a substantial market advantage.

The cost-effectiveness of monoclonal antibodies against gram-negative endotoxin (MAbGNE) in the treatment of presumed gram-negative sepsis for $2,000 and $4,000 acquisition costs, for example, was, according to the E5 or HA-1A MAbGNE study estimated at $71,674 and $74,900 per probability of survival, respectively. MAbGNE-as well as several of the agents being studied-is expensive and cannot be justified on a cost-saving basis, though it may be cost-effective throughout a reasonable range of assumptions.

Drotrecogin alpha (Xigris, recombinant activated protein C) is an anticoagulant developed and launched by Eli Lilly & Co for the treatment of sepsis; it is likely to cost from $3,000 to $10,000 per patient per course of therapy, which is 10 times higher as compared to the estimated cost of sophorolipids.

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	Microbial Glyco 23 is a new a class of membrane-derived glycolipids that have wide-ranging potential in clinical practice. We have demonstrated that Glyco 23 possesses remarkable protective effect, in terms of survival, anti-inflammatory and anti-necrotic activity in sepsis. Compelling preclinical survival and histological data was obtained from lung, liver and kidney, as well as cytokine profiles in small animals. In vivo experiments indicate that both intraperitoneal and intravenous injection of natural and select Glyco 23 components during cecal ligation, in puncture and endotoxin (galactosamine-LPS model)-induced rodent sepsis models, have a protective effect against the morbidity of systemic sepsis; and that these protective effects persist when sophorolipids are administered during and after the sepsis insult. In vitro experiments indicate that Glyco 23 derivatives and mixtures have immunomodulatory characteristics after exposure to lipopolysaccharide, specifically by decreasing production of pro-inflammatory cytokines. Furthermore, Glyco 23 affects other important anti-inflammatory immune responses, including regulation of cell surface adhesion molecule expression, and the ability to exert antimicrobial effects. About Sepsis Sepsis is widely regarded as the most challenging problem in intensive care, a direct consequence of the complexity of the disease, and heterogeneity of the patient population. It is a rapidly progressing disease with up to 80% associated mortality. Disease management is predominantly non-specific, relying on a range of interventions. Current diagnostics fail to allow for rapid and accurate diagnosis. Incidence of sepsis continues to rise across the developed world, with US increases of 1.5% per annum expected until 2020. Over 7 million people annually become susceptible to sepsis, and 250,000 Americans die from sepsis each year. Severe sepsis has an annual incidence exceeding three quarters of a million cases, a 28.6% overall hospital mortality rate, and an average cost of $22,100 per case,. Total annual costs for severe sepsis were estimated to be $16.7 billion. The rate of sepsis due to fungal organisms increased by 207 percent; with gram-positive bacteria becoming the predominant pathogen after 1987. Rising disease incidence has been fueled by the growing number of surgical interventions, and an increase in immunocompromization. Strategic Advantage Glyco 23 has two fundamental advantages over competitors: Minimal toxicity and low cost. While activated protein C-as well as several of the above-mentioned technologies, as of yet not completely understood-has a narrow use and high price point, which limit sales; Glyco 23 would be recommended with almost no contraindications; and could be marketed at a very affordable cost. It is clear that price reduction may lead to wider use, and provide a substantial market advantage. The cost-effectiveness of monoclonal antibodies against gram-negative endotoxin (MAbGNE) in the treatment of presumed gram-negative sepsis for $2,000 and $4,000 acquisition costs, for example, was, according to the E5 or HA-1A MAbGNE study estimated at $71,674 and $74,900 per probability of survival, respectively. MAbGNE-as well as several of the agents being studied-is expensive and cannot be justified on a cost-saving basis, though it may be cost-effective throughout a reasonable range of assumptions. Drotrecogin alpha (Xigris, recombinant activated protein C) is an anticoagulant developed and launched by Eli Lilly & Co for the treatment of sepsis; it is likely to cost from $3,000 to $10,000 per patient per course of therapy, which is 10 times higher as compared to the estimated cost of sophorolipids.