New Therapeutic Option for Irritable Bowel Syndrome: Serum-Derived Bovine Immunoglobulin

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Entera Health, Inc. Announces the Publication of a Case Series that Summarizes Positive Responses to Oral Administration of Serum-Derived Bovine Immunoglobulin/Protein Isolate (SBI) in Patients with Multiple Forms of IBS.

Entera Health

Entera Health, Inc. announced today the publication of a new report in World Journal of Gastroenterology, that outlines a series of clinical cases on the use EnteraGam™ (serum-derived bovine immunoglobulin/protein isolate; SBI) in the management of different forms of irritable bowel syndrome (IBS). Authors include: Larry Good, MD (Lynbrook, NY USA), Roxanne Rosario, BS (Lynbrook, NY USA) and Raymond Panas, PhD (Cary, NC USA).

This retrospective case analysis describes 14 IBS patients who received SBI in addition to standard of care at the clinical practice of a physician. The IBS patients described in the study included 2 with constipation (IBS-C), 7 with diarrhea (IBS-D), 2 with mixed diarrhea and constipation (IBS-M), and 3 with bloating or undefined IBS (IBS-U), who ranged in age from 22-87 years. Twelve of the 14 patients who continued on therapy reported better overall management of their IBS conditions. Reported symptom outcomes were better stool consistency, decreased frequency as well as reductions in abdominal discomfort, bloating, distention, and incontinence. In most cases, therapeutic effects of SBI were seen within the first four weeks of therapy with continued improvements in condition management at subsequent visits. Authors of the study concluded that SBI as a medical food provides a safe option for patients with IBS-D but may also have application in other forms of IBS.

About Irritable Bowel Syndrome (IBS)
Irritable bowel syndrome (IBS) is a complex and commonly diagnosed gastrointestinal disorder, characterized by recurrent abdominal pain or discomfort associated with altered bowel habits, that negatively affects patients’ daily activities and quality of life. Population-based studies indicate that the worldwide prevalence of IBS is approximately 9% to 22%. Symptoms may include abnormal stool form or frequency, defecation straining, bloating, urgency, feelings of incomplete bowel movement, and passing mucus. It is further categorized based upon stool consistency leading to a diagnosis of IBS with either constipation (IBS-C), diarrhea (IBS-D), mixed with alternating constipation and diarrhea (IBS-M) or undefined (IBS-U) which may have symptoms of bloating and distention. 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 for these patients.

About EnteraGam®
EnteraGam® is a prescription medical food product intended to provide for distinctive nutritional requirements that are unique for the clinical dietary management of specific intestinal disorders [e.g., in irritable bowel syndrome with diarrhea (IBS-D), inflammatory bowel disease (IBD), 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@enterahealth.com

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Tom Heck, Chief Operating Officer
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