TORRANCE, Calif.--(BUSINESS WIRE)--Emmaus will present results of a Phase 3 study of Endari (L-glutamine oral powder) for sickle cell disease treatment at the 59th Annual Meeting of the American Society of Hematology (ASH) taking place in Atlanta, Georgia December 9-12, 2017. The ASH abstract is now available at https://ash.confex.com/ash/2017/webprogram/Paper108433.html.
Details of the oral presentation are as follows:
Publication Number: 685
TITLE: Phase 3 Study of L-glutamine in Sickle Cell Disease: Analyses of Time to First and Second Crisis and Average Cumulative Recurrent Events
Name: 114. Hemoglobinopathies, Excluding Thalassemia—Clinical II
Date: Monday, December 11, 2017
Time: 2:45 PM – 4:15 PM
Room: Georgia World Congress Center, Building B, Level 3, B308-B309
The results to be presented demonstrated that the average cumulative crisis count was reduced by approximately 25% over the 48-week study. Endari, approved by the Food and Drug Administration (FDA), is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older. The most common adverse reactions occurring in greater than 10 percent in clinical studies were constipation, nausea, headache, abdominal pain, cough, pain in extremity, back pain, and chest pain. Endari is the first FDA-approved treatment for pediatric patients with sickle cell disease, and the first new treatment in nearly 20 years for adult patients. Endari has received Orphan Drug designation in the U.S., Orphan Medicinal Product designation in the EU.
About Sickle Cell Disease
Sickle Cell Disease is an inherited blood disorder characterized by the production of an altered form of hemoglobin which polymerizes and becomes fıbrous, causing red blood cells to become rigid and change form so that they appear sickle shaped instead of soft and rounded. Patients with Sickle Cell Disease suffer from debilitating episodes of sickle cell crises, which occur when the rigid, adhesive and inflexible red blood cells occlude blood vessels. Sickle cell crises cause excruciating pain as a result of insufficient oxygen being delivered to tissue, referred to as tissue ischemia, and inflammation. These events may lead to organ damage, stroke, pulmonary complications, skin ulceration, infection and a variety of other adverse outcomes. Sickle Cell Disease is an orphan disease, affecting approximately 100,000 patients in the U.S. and millions worldwide with significant unmet medical needs.
About Emmaus Life Sciences
Emmaus Life Sciences, Inc. is engaged in the discovery, development and commercialization of innovative treatments and therapies for rare diseases. The company's research on sickle cell disease was initiated by Yutaka Niihara, MD, MPH, Chairman and CEO of Emmaus, at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center. For more information, please visit www.emmauslifesciences.com.
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and potential commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. Additional risks and uncertainties are described in reports filed by Emmaus Life Sciences, Inc. with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Emmaus is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.