New Data Presented At The 2014 Annual Meeting Of The American College Of Gastroenterology (ACG)

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New Findings for EnteraGam™ (Serum-derived bovine immunoglobulin/protein isolate, SBI)

Entera Health

Entera Health, Inc. announced today three poster presentations that were given at the Annual Meeting of the American College of Gastroenterology meeting (ACG 2014), held on October 17-22 in Philadelphia, PA.

Dr. Gerald Dryden (University of Louisville School of Medicine, Louisville, KY) presented a case report on the use of the prescription medical food, EnteraGam™ (serum-derived bovine immunoglobulin/protein isolate, SBI) to provide for the distinct nutritional requirements to manage refractory ulcerative colitis (UC) in this patient (1). The 60-year old patient with a 10-year history of UC had discontinued anti-TNF therapy and later experienced 2 episodes of Clostridium difficile infection (following antibiotic treatment for septic arthritis) that led to the development of a severe flare of UC about 3 months later (grade 2 colitis by sigmoidoscopy). The patient was reluctant to re-initiate anti-TNF therapy due to her history of septic arthritis and in declining health (including 10 to 15 watery stools per day with frequent bleeding), which led to consideration of planned surgery. Initiation of SBI therapy at 5 g QID for one week and then decreased to 5 g per day led to dramatically improved symptoms (1 to 2 formed bowel movements per day, no rectal bleeding or abdominal cramps) and endoscopic improvement (grade 0 colitis), leading to over 6 months of remission and discontinued consideration of the planned surgery to resolve symptoms. In addition, the patient’s albumin levels normalized illustrated a dietary impact.

Dr. Larry Good (State University of New York, Stonybrook, NY) presented a second case report of a patient with severe fecal incontinence (FI) associated with chronic mesenteric ischemia (CMI) due to obstructions in the arteries that feed the intestine in the patient who received SBI therapy (2). The patient had a 20-year history of chronic diarrhea (6-8 watery stools per day) and FI and was unresponsive to a number of conventional anti-diarrheal drug therapies. Within four weeks of initiating oral SBI therapy (5 g daily), the patient reported a dramatic amelioration of symptoms, including reductions in abdominal pain, diarrhea (2-3 formed stools per day), incontinence, and urgency to defecate along with an improvement in quality of life, which after 20 years, has allowed this patient to resume normal activities, including travel and socialization.

Dr. Raouf Hilal (Center for Advanced Gastroenterology, Maitland, FL) presented a third case report on the effect of SBI therapy in providing for distinctive nutritional requirements in in a 37-year old patient with short bowel syndrome (95 cm of remaining small bowel) (3). The patient had multiple comorbidities and continued to experience generalized abdominal pain, bloating/distention, chronic diarrhea, weight loss, below normal nutritional blood markers and poor quality of life. Initially placing the patient on SBI 5 g/d for 6 months resulted in only minor improvements in gastrointestinal (GI) symptoms, but normalized nutritional blood markers like calcium, total protein, albumin and hemoglobulin. Discontinuation of SBI led to a flare up of symptoms that plummeted these nutritional markers and resulted in hospitalization where the patient began to receive total parental nutrition (TPN) along with 5 g SBI BID. The addition of SBI as part of standard-of-care nutritional support again led to a dramatic reduction in bloating/distention, abdominal pain, diarrhea frequency and consistency (i.e. 5-10 stools per day decreased to 2-3 stools per day), along with normalized levels of serum calcium, total protein and albumin levels as well as other nutritional markers. The patient also experienced dramatically improved quality of life and is now weaned TPN.

Three educational presentations on EnteraGam™ were also featured during a 60-minute product theater event. These presentations provided summary information on: (1) the mechanism of action and medical food designation of SBI; (2) evidence of clinical benefit for SBI in patients with enteropathy due to IBS-D or HIV infection (see references 4, 5 below); and (3) a series of case reports describing self-reported benefits from SBI by patients with IBS-D.    

About EnteraGam™
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 http://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 http://www.enterahealth.com/.

For questions, please contact:
Tom Heck, Chief Operating Officer
515-963-7560
tom.heck(at)enterahealth(dot)com

Citations:
1.Dryden G. Use of Serum-Derived Bovine Immunoglobulin/Protein Isolate (SBI) to Manage Refractory Ulcerative Colitis Symptoms and Avoid Surgery. American College of Gastroenterology, Oct 17-22, 2014, Philadelphia, PA.
2. Good L. Fecal Incontinence with Chronic Mesenteric Ichemia: Case Report in Response to Serum-Derived Bovine Immunoglobulin/Protein Isolate. American College of Gastroenterology, Oct 17-22, 2014, Philadelphia, PA.
3. Hilal R. A Case of Short Bowel Syndrome Managed with a Prescription Medical Food Product, Serum-Derived Bovine Immunoglobulin/Protein Isolate (SBI). American College of Gastroenterology, Oct 17-22, 2014, Philadelphia, PA.
4. Asmuth DM, et al. Oral Serum-Derived Bovine Immunoglobulin Improves Duodenal Immune Reconstitution and Absorption Function in Patients with HIV Enteropathy. AIDS 2013; 27: 2207-2217
5. Wilson D et al. Evaluation of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects with Diarrhea-Predominant Irritable Bowel Syndrome. Clin Med Insights: Gastroenterol 2013: 6:49-60.

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Tom Heck, Chief Operating Officer
Entera Health
+1 (515) 963-7560
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