HERENTALS, Belgium, July 6 /PRNewswire/ -- Researchers at Kemin Pharma announce a significant breakthrough in the treatment of Clostridium difficile associated diarrhea (CDAD), the most common form of antibiotic-associated diarrhea among hospital and long-term care facility patients. Recently completed in vitro assays by Kemin Pharma, scientists confirmed that their unique and patented biotherapeutic, KPE02004001, is active against C. difficile NAP1/027, a lethal strain of the bacteria linked to hospital outbreaks of CDAD in Canada, the United States, Great Britain and the Netherlands. The NAP1/027 strain produces a large quantity of toxins and is resistant to fluoroquinolone antibiotics. Unusual frequency, greater severity and more unexpected cases of CDAD may indicate new, more virulent strains of the bacteria.
Kemin scientists were aware of KPE02004001's ability to selectively kill pathogenic bacteria like Clostridium, Campylobacter and Helicobacter pylori without being harmful to health-promoting bacteria such as lactobacilli. In fact, the compound actually promotes the growth of lactobacilli and stimulates the immune system.
Kemin Pharma has conducted extensive safety and toxicity studies with KPE02004001 and has observed no toxicity even when dosed at 5000mg/Kg of body weight. As dictated by law, the product was first tested in healthy volunteers without any side effects. In vivo animal models that mimic the CDAD conditions in humans have shown that the compound is as effective as vancomycin, one of the antibiotics currently used to treat the disease, without the adverse events associated with the antibiotic.
CDAD is most common in hospitalized patients or patients in long-term care facilities, presumably because of the increased antibiotic usage in these settings. C. difficile and its spores survive well in these environments and are easily transmitted from infected patients to susceptible persons. Controlling CDAD is difficult because the infected patient does not often exhibit noticeable symptoms. In addition, a number of recently isolated strains of C. difficile have become resistant to antibiotics.
Antibiotic therapy often causes a severe disruption of the ecological balance of microbial flora in the gastrointestinal tract. This imbalance can lead to an overgrowth of potentially pathogenic microorganisms often resulting in antibiotic-associated diarrhea (AAD). In 15 to 25% of the cases, AAD is caused by C. difficile. CDAD is currently treated with antibiotics such as metrodinazole or vancomycin. Patients often have a relapse or develop a resistance to these treatments. In these instances, there is no alternative recourse for the patient.
Kemin Pharma has received approval from the Ministry of Health to start a double-blinded, placebo controlled clinical trial with CDAD patients. Researchers anticipate the results will be similar to those observed in the animal models. Kemin Pharma hopes that the final product will provide a solution to AAD, specifically CDAD.
CONTACT: Dr. Benedikt Sas, President, Kemin Pharma Europe, Atealaan 4H,+22.214.171.124.60 (phone), or +126.96.36.199.68 (fax), orBenedikt.Sas@kemin.com