MANAGEMENT OF DRUG-REFRACTORY IBS WITH BOVINE IMMUNOGLOBULIN PROTEIN ISOLATE

Entera Health, Inc. Announces the Publication of a Scientific Article Summarizing Positive Responses to Oral Administration of Serum-Derived Bovine Immunoglobulin/Protein Isolate (SBI) in 10 Patients with Drug-Refractory IBS.

Entera Health, Inc. announced today the publication of a new case series report in the Open Journal of Gastroenterology (OJG), supporting the benefits of EnteraGam™ (serum-derived bovine immunoglobulin/protein isolate, SBI) in 10 patients with histories of long-standing, intractable and drug-refractory irritable bowel syndrome with diarrhea (IBS-D) or with abdominal pain, gas/bloating and distention, referred to as undefined IBS (IBS-U). Authors include: Raouf Hilal, MD (University of Central Florida Medical School, Orlando, FL United States and Center for Advanced Gastroenterology, Maitland, FL), Patricia Mitchell, MD (San Antonio, TX), Ernesto Guerra Jr., MD (San Antonio, TX), and Bruce P. Burnett, PhD (Cary, NC).

Oral administration of immunoglobulin-containing serum protein preparations such as SBI, specially formulated to increase levels of IgG and other proteins in the intestinal tract, have been recently found to provide for the distinct nutritional requirement of these proteins in the effective management of enteropathy associated with IBS-D and HIV infection (1,2). The case series report published in OJG evaluated the responses of 10 patients who met Rome III criteria for IBS and were deemed refractory to a variety of treatment options (i.e. anti-diarrheal and antispasmodic medications, serotonin 5-HT3 receptor antagonists, selective serotonin re-uptake inhibitors (SSRIs), antibiotics, etc.), and were administered SBI at 5 g/day as standard-of-care nutritional support. When prompted, patients reported significant IBS symptom improvement, which averaged between 50 to 100% (p = 0.002) with an average for management in all patients of 69%. No side effects were reported after SBI administration even when taken for up to 28 weeks. The article can be accessed on line at: http://www.scirp.org/journal/PaperInformation.aspx?PaperID=50521

About Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

Irritable bowel syndrome (IBS) is a complex and commonly diagnosed gastrointestinal (GI) disorder characterized by recurrent abdominal pain or discomfort associated with altered bowel habits that negatively affects patients’ daily activities and quality of life. Symptoms may include abnormal stool form or frequency, defecation straining, bloating, urgency, feelings of incomplete bowel movement, and passing mucus. Studies indicate that the worldwide prevalence of IBS is approximately 10% to 20%. While the cause of IBS is still largely unknown, a variety of factors have been considered to play a role, including genetics, diet, infections, psychosocial factors, and changes in gut motility or barrier function. Recent studies have also highlighted the potential role of low grade inflammation, often in association with alterations in the microbiota composition or metabolism, which may cause changes in gut barrier function with increased permeability and subsequent malabsorption of water, electrolytes, and nutrients. Such factors or host system changes can lead to alterations in nutritional status, which can further contribute to symptoms. Unfortunately, most therapies that are currently used to manage patients with IBS are aimed at lessening symptoms rather than the underlying cause of the disorder, which has led to an increased interest in multi-modal therapeutic approaches aimed at restoring intestinal health and nutritional status.

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 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
515-963-7560
Tom.heck@enterahealth.com

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