The Need

Infectious diarrhea

Worldwide, infectious diarrhea is responsible for approximately 20% of all mortality in children under the age of 5, and for an estimated 2 million deaths annually. In addition to directly causing illness and death, diarrhea contributes to mortality from other diseases in children, including malnutrition and malaria. In the United States, although the overall infectious diarrhea mortality rate is lower, the disease nevertheless has an annual incidence of over 375 million cases in pediatric and adult populations, and is responsible for approximately 900,000 hospitalizations and 6,000 deaths per year. Included in these numbers are 200,000 children under five years of age hospitalized in the U.S. each year with active diarrheal disease, accounting for nearly 880,000 inpatient days, over 500 deaths, and almost one billion dollars of inpatient cost.

Traveler's diarrhea

Traveler's diarrhea impacts 20-50% of international travelers each year, with an incidence of more than 10,000,000 cases annually. In addition, there is recent data indicating that as many as 10% of traveler's diarrhea cases progress to irritable bowel syndrome. A recently completed study indicates that the traveler's diarrhea prophylactic market could exceed $750 million annually. Currently, the only effective treatments involve antibiotics, resulting over time in increased pathogen resistance. Glycosyn's OTC products will be available following production development and testing.

Animal Health

Glycosyn's preliminary data suggests that its products may significantly impact diarrhea in animals, including cattle, pigs, horses and chickens. Debilitating and fatal diarrhea in calves, shoats and other young animals is a major problem for the US and global animal industries. Scours, a diarrheal disease caused primarily by E. coli, (a pathogen targeted by Glycosyn's products), causes about 25% of all nursery and pre-weaned swine deaths and is the largest single cause of disease and death in calves. Products should be available for testing and distribution early in 2010.

Necrotizing enterocolitis (NEC)

Necrotizing Enterocolitis (NEC) is a major cause of illness and death for low-birthweight babies in the US and around the world. It is their most common gastrointestinal medical/ surgical emergency, occurring in 7-13% of very low birthweight infants, and involves bowel injury and intestinal necrosis. Mortality rates from NEC range from 20-40%, and may exceed 50% for premature infants. Surgery is required in about 30% of the cases, with surgery-associated mortality as high as 50%. Overall, about 25,000 US babies per year develop NEC, and at least 20% die. Currently there are no available methods for diagnosing relative risk of NEC, and no generally accepted treatment.