Potential benefits of EnteraGam™ (Serum-derived bovine immunoglobulin/protein isolate,SBI)
Entera Health, Inc. announces today three poster presentations that were presented at the annual Crohn’s & Colitis Foundation’s Clinical & Research Conference , titled "2014 Advances In Inflammatory Bowel Diseases", held on December 4-6 in Orlando, FL.
Dr. Larry Good (State University of New York, Stonybrook, NY) presented a retrospective case study on the use of the prescription medical food, EnteraGam™ (serum-derived bovine immunoglobulin/protein isolate, SBI) to manage symptoms in three patient with ulcerative colitis (UC). In each of the cases, the patients had experienced episodes of chronic loose and frequent stools, along with a variety of other symptoms, and had been treated for their ulcerative colitis with conventional therapy but failed to respond adequately. The addition of SBI at 5 g/day resulted in a significant and/or complete management of symptoms associated with their ulcerative colitis, which included significant reductions in bowel movements, urgency, and nocturnal episodes as well as elimination of blood and mucus in stools.
Dr. Larry Good (State University of New York, Stoneybrook, NY) also presented results from a second case study on four patients with Crohn's disease and their response to SBI therapy. The four patients ranged in age from 21 to 54 and had experienced recent exacerbations of their Crohn's disease with varying symptoms that included abdominal pain, diarrhea, anorexia, and weight loss. Several patients had received conventional treatment regimens for their Crohn's disease but they continued to experience symptoms. In each of these cases, the use of SBI therapy 5g QD or BID provided for initial management of symptoms, which differed among patients but included a reduction in ostomy output, elimination of cramps and abdominal pain, steady weight gain, and overall decrease in use of concurrent conventional medications used to manage their Crohn’s disease. The ongoing use of SBI therapy has helped in the continued management of each of the patient’s chronic condition.
Dr. Abigail Henderson (Cary, NC USA) presented new results from preclinical studies conducted with colleagues at Harvard Medical School on the potential use of SBI for antibiotic-associated diarrhea caused by the bacterium known as Clostridium difficile. Dr. Henderson reported that mice maintained on a low protein diet and undergoing experimental infection with C. difficile showed lower overall mortality when given SBI compared to mice given collagen as a control protein (P=0.005). No difference was observed in mortality among mice given SBI or collagen when they were maintained on a normal protein diet. Future studies will focus on how the immunoglobulin protein mixture in SBI impacts either intestinal colonization by C. difficile or the ability of mice to resist infection in the malnourished state.
EnteraGam™ (serum-derived bovine immunoglobulin/protein isolate, SBI) is a prescription medical food product indicated for the clinical dietary management of enteropathy [e.g., in diarrhea-predominant irritable bowel syndrome (IBS-D) and HIV-associated enteropathy]. EnteraGam™ is required to be used under physician supervision as part of ongoing medical care for a specific condition or disease. EnteraGam™ is also indicated for the clinical dietary management of enteropathy in patients who, because of therapeutic or chronic medical needs, have limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients. For full prescribing information, please visit our product website at www.enteragam.com.
Important Safety Information
EnteraGam™ is a specially formulated protein source for the management of intestinal disorders. The product has been extremely well tolerated for up to a year in HIV patients and up to 8 months in infants. The major side effects in clinical trials (2-5%) have included mild nausea, constipation, stomach cramps, headache, and increased urination. EnteraGam™ is contraindicated for patients with a hypersensitivity (allergy) to beef, or any components in EnteraGam™. Therefore, patients who have an allergy to beef or any component of EnteraGam™ should not take this product. EnteraGam™ has not been studied in pregnant and nursing mothers. The choice to administer EnteraGam™ in pregnant or nursing mothers is at the clinical discretion of the physician. Medical foods like EnteraGam™ are required by FDA regulations to be dosed and monitored by physicians as part of ongoing care for patients with chronic conditions or diseases.
About Entera Health, Inc.
Entera Health, Inc. is focused on improving worldwide health through the development of clinically safe biotherapeutics to address unmet needs. Our passion is to help people thrive through healthier living. Our motivation for conducting basic research, clinical studies, and appropriately educating patients and healthcare providers is driven to meet this goal. Visit us at www.enterahealth.com.
For questions, please contact:
Tom Heck, Chief Operating Officer