Entrinsic Health Solutions and Markey Cancer Center Launch Phase II Study for Neuroendocrine Tumor Patients with Quality of Life-Limiting Diarrhea
NORWOOD, Mass., Dec. 12, 2018 /PRNewswire/ -- Entrinsic Health Solutions in partnership with the University of Kentucky (UK) Markey Cancer Center today announced initiation of active accrual and first consented patient in its Phase II study evaluating enterade® – a glucose-free, medical food – in neuroendocrine tumor and carcinoid syndrome patients. Findings from this study may show that enterade can help maintain the small bowel's ability to retain fluids leading to a reduction in stool frequency. The study will also examine the effects of enterade on patient-reported gastrointestinal symptoms and quality of life.
"One of the most debilitating symptoms as a result of neuroendocrine tumors is chronic diarrhea, which occurs in about 78% of patients with carcinoid syndrome. Moreover, despite the high prevalence of severe diarrhea in this population, there are limited nutritional options for patients," said Lowell B. Anthony, MD, FACP, Principal Investigator and Chief, Division of Medical Oncology at UK Markey Cancer Center. "By delivering distinct nutritional requirements, we hypothesize that enterade can restore electrolyte imbalance, and in turn, alleviate gastrointestinal symptoms related to neuroendocrine tumors, like diarrhea."
"In our previous pilot study, enterade was shown to be quite effective in reducing stool frequency and improving the quality of life of patients who took the product for as little as 10 days," said Stephen Gatto, Chairman and CEO for Entrinsic Health Solutions. "Our expectation is that this carefully designed Phase II study will provide the necessary validation to support enterade's broad use as a front line supportive care approach to addressing the negative side effects due to neuroendocrine tumors and carcinoid syndrome."
Leveraging the power of amino acids, oncologists and gastroenterologists developed enterade to actively address the distinct changes to the gastrointestinal tract during cancer treatment which impact absorption, digestion and immune function.
For the study, two distinct patient cohorts will be enrolled: carcinoid syndrome diarrhea and non-carcinoid syndrome diarrhea. The primary endpoint is restoration of gut health by improving intestinal absorption and reduction in frequency of diarrhea. Weeks 1-4 will be an observation period to assess baseline stool output. During weeks 5-8, eligible patients will drink two bottles of enterade each day. After this point, patients will be off enterade and observed for four weeks.
For more information on the study, please visit ClinicalTrials.gov (ID: NCT:03722511).
enterade is a first-in-class, glucose-free medical food that is composed of five critical amino acids (Valine, Aspartic Acid, Serine, Threonine, Tyrosine) and electrolytes (potassium and sodium) to help manage debilitating gastrointestinal (GI) side effects. With no sugar to exacerbate the GI tract, enterade supports the small bowel's ability to absorb fluids, nutrients, and electrolytes and leads to improved digestive function. By helping to restore normal GI function, enterade reduces dehydration and related diarrhea, leading to a significant improvement in the patient's overall quality of life and a healthier GI tract. For more information, please visit www.enterade.com and connect with the brand on Facebook, Instagram, and Twitter.
About University of Kentucky Markey Cancer Center
Markey Cancer Center has provided state-of-the-art cancer care for more than 20 years and is the only cancer center in Kentucky designated by the National Cancer Institute. In August 2017, Markey was designated as one of the Top 50 Cancer Centers in the nation by U.S. News & World Report. Its expert teams of physicians, nurses and other health care providers have experience working with patients in a compassionate and caring environment.
About Entrinsic Health Solutions Inc.
Entrinsic Health Solutions, Inc., is a recognized leader in the development, manufacturing and commercialization of disruptive, science-derived amino-acid technologies that are clinically-proven to deliver better health outcomes in a broad range of therapeutic areas including gut health, hydration, skin and respiratory health. The Company's proprietary Amino Acid Coupled-Transport (A₂CT™) technology platform leverages gold-standard science and harnesses game-changing amino acid technology to address critical health issues. A₂CT™ is a highly customizable transport system for addressing multiple target conditions and disease states. EHS has ongoing research and development that leverages amino acid science and technology for consumer health, therapeutics and performance hydration.
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