Enterade USA Announces Enrollment of the First Patient in a Phase II Study of Enterade® to Maintain Bowel Regularity in Individuals with GI Toxicity from Cancer Therapy
Medical Food Offers New Promise as Adjunct to Standard of Care to Reduce Diarrhea Incidence and Restore Normal Bowel Function
Newberry, Fla. and Boston, MA (May 7th 2015): Entrinsic Health Solutions LLC, an innovative health sciences company, today announced the enrollment of the first patient in its Phase II clinical trial to investigate the impact of Enterade® medical food on restoring and maintaining bowel regularity in individuals receiving chemotherapy and radiation therapy. Nearly half of all individuals receiving cancer therapy experience treatment-induced gastrointestinal (GI) toxicity and enteritis often leading to acute diarrhea, dehydration, which ultimately can lead to breaks in cancer treatment, undermining the clinical efficacy of therapy.
“We believe there is a clear unmet need in oncology for a product that can help individuals with cancer better tolerate therapy and minimize the debilitating side effects of treatment that significantly undermine quality of life,” said Stephen J. Gatto, Chairman and Chief Executive Officer at Entrinsic Health Solutions. “The dosing of the first patient represents a significant milestone towards the commercialization of Enterade as an important and critical adjunct product for healthcare professionals and individuals with cancer. We look forward to this trial advancing quickly and to making this product broadly available as a physician-recommended medical food.”
The Phase II clinical study is a randomized, open label trial in which approximately 46 patients with cancer treatment-induced diarrhea will be randomized to receive Enterade and loperamide (standard-of-care) or loperaminde alone for GI symptom management. The primary endpoint is the improvement in bowel regularity and hydration status in patients undergoing chemotherapy and radiation. The trial is statistically powered to recognize a 20% improvement in bowel regularity. Secondary endpoints include improvements in quality of life and fatigue, nausea reduction, and loss of appetite, weight loss, and alteration in the use of other bowel symptom medications. The clinical study is being conducted at 21st Century Oncology. For more information, please refer to www.clinicaltrials.gov, NTC02381405.
Enterade is an innovative medical food that improves uptake of fluids and electrolytes in individuals undergoing cancer treatment. Its amino acid, glucose-free formulation helps to repair and restore normal GI function and aids individuals with cancer manage the side effects of treatment including diarrhea and dehydration. Enterade may help individuals maintain normal body weight and therefore, may assist individuals better tolerate their full course of cancer therapy. All ingredients contained in Enterade are GRAS (Generally Accepted as Safe), a designation used by the U.S. Food and Drug Administration to classify components of food that are safe and suitable for extensive use in the US population.
About Enterade® Medical Food
Enterade medical food was formulated based on seminal research conducted by Entrinsic Health Solutions. This research demonstrated that well-known ion transport pathways in the intestinal villi are severely compromised when the body is subjected to extreme stress, as from cancer therapy (chemotherapy or radiation), bacterial or viral infections, or other environmental / external factors, such as extreme exercise. In these conditions, damaged or blunted villi in the gut ileum interrupt the normal sodium and glucose transport mechanism in the intestinal epithelial, thereby shutting down absorption of these key nutrients. This diminished absorption leads to increased concentrations of glucose in the intestinal lumen, which stimulates secretion of chloride and water into the lumen, causing diarrhea or worsening a diarrheal state that may already be present. Enterade, in preclinical models, has increased electrolyte absorption, decreased paracellular permeability, tightened the mucosal barrier and improved the size and shape of the blunted villi.
About Entrinsic Health Solutions
Entrinsic Health Solutions LLC, is an innovative health sciences company advancing patient care and wellness through health and nutritional sciences. Our mission is to provide products that help people realize a better quality of life by providing solutions to optimize gastrointestinal health in times of sickness as well as through top performance periods.
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