NEW CASE REPORT SERIES: ORAL IMMUNOGLOBULIN AND IBD

Entera Health, Inc. announced today the publication of a new clinical case series report in the Journal of Gastrointestinal & Digestive System that summarizes a retrospective evaluation of seven patients with ulcerative colitis (UC) or Crohn’s disease (CD) who had EnteraGam® (serum-derived bovine immunoglobulin/protein isolate, SBI) incorporated into their therapeutic regimens after failing to respond adequately to conventional therapies. Authors include: Larry Good, MD (South Nassau Communities Hospital, Oceanside, NY) and Raymond Panas, PhD (Cary, NC).

This case series report describes the clinical response of seven patients with UC (n=3) or CD (n=4) in a standard clinical practice who were all determined to be refractory to conventional IBD therapy and subsequently were provided SBI as part of a standard-of-care nutritional therapy regimen. SBI was considered for therapy in these patients due to earlier reports of positive results in the management of chronic loose and frequent stools associated with a variety of gastrointestinal conditions [1-3]. All three UC patients in this new study reported improvement of symptoms, starting 3 to 6 weeks after initiating SBI therapy at 5 g once or twice daily. Symptom improvement included decreases in rectal bleeding, diarrhea, urgency, and/or nocturnal incontinence. In two of the three UC patients, complete resolution of loose and frequent stools was reported. Likewise, all four patients with CD experienced improvements in symptoms or other beneficial outcomes as early as 4 weeks after initiating SBI therapy. One patient experienced a dramatic reduction in daily ileostomy output and creatinine levels, two patients were able to reduce levels of concurrent drug therapies, and the fourth patient experienced an increase in body weight. The authors conclude that SBI may be a unique nutritional add-on therapy that can assist in the clinical management of IBD patients whose symptoms are not fully controlled on traditional therapies alone.

READ THE FULL ARTICLE.

About Inflammatory Bowel Disease (IBD)

Inflammatory Bowel Disease (IBD) is a chronic inflammatory condition resulting from an immune dysregulation of the intestinal tract, the cause of which remains to be determined [4]. In the US alone, it is estimated that IBD affects more than 1.6 million individuals [5]. The immune dysregulation that occurs in patients with IBD results in two distinct disease states: ulcerative colitis (UC) and Crohn’s disease (CD). Ulcerative colitis is a disease of unknown etiology that produces chronic inflammation of the colon, whereas CD is a relapsing inflammatory condition affecting any part of the gastrointestinal tract. Patients with UC often present with symptoms of bloody loose stools, abdominal cramps, and fatigue [6], while patients with CD frequently present with symptoms of abdominal pain, fever, and clinical signs of bowel obstruction or bloody loose stools or mucus [7]. Evidence suggests that many factors contribute to IBD, which partly explains why current treatment methods target the clinical symptoms associated with the inflammatory and immune response in an effort to avoid the need for surgery and address complications associated with IBD [4]. Since there is no cure for IBD, current treatment goals recommended by the Crohn’s and Colitis Foundation of America are to induce remission, maintain remission by preventing flare-ups, and improve overall quality of life.

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.

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. The staff’s passion is to help people thrive through healthier living. The staff’s 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 information, please contact:

Tom Heck, Chief Operating Officer

515-963-7560

Tom.Heck@enterahealth.com

REFERENCES:

1. Wilson, D., et al. (2012) Evaluation of serum-derived bovine immunoglobulin protein isolate in subjects with diarrhea-predominant irritable bowel syndrome. Clin Med Insights Gastroenterol l6: 49-60.

2. Good, L., and B.P. Burnett. (2015) Management of Loose, Frequent Stools and Fecal Incontinence in a Chronic Mesenteric Ischemia Patient with Oral Serum-derived Bovine Immunoglobulin. Clin Med Insights Gastroenterol 8: 7-11.

3. Dryden, G.W., and V.S. Jasion. (2014) Use of serum-derived bovine immunoglobulin/protein isolate (SBI) to manage refractory ulcerative colitis symptoms and avoid surgery. Presented at 2014 Annual Meeting American College of Gastroenterology (ACG), October 17-22, 2014, Philadelphia, PA.

4. Levesque, B.G., et al. (2015) Converging goals of treatment of inflammatory bowel disease from clinical trials and practice. Gastroenterology 148: 37-51.

5. Baumgart, D.C., and W.J. Sandborn. (2012) Crohn's disease. Lancet 380: 1590-1605.

6. Crohn’s and Colitis Foundation of America. (2014) The facts about inflammatory bowel disease 1-20.

7. Danese, S, and C. Fiocchi. (2011) Ulcerative colitis. N Engl J Med 365: 1713-1725.

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