Emmaus Medical, Inc., a biopharmaceutical company engaged in the discovery, development and commercialization of innovative and cost-effective treatments and therapies primarily for rare and orphan diseases, today announced it has completed all patient visits for its Phase 3 clinical trial for the treatment of sickle cell disease. Emmaus expects top-line data from the Phase 3 clinical trial to be available in the first quarter of 2014.
The Phase 3 trial, which completed enrollment in December 2012, was a prospective, randomized, double-blind, placebo-controlled, parallel-group, multi-center study designed to evaluate the safety and efficacy of L-glutamine as a therapy for sickle cell anemia and sickle β0-thalassemia. Study enrollment totaled 230 patients across 31 sites in the United States.
“We are very proud to have completed the last patient visit of our Phase 3 clinical trial,” said Dr. Yutaka Niihara, M.D., M.P.H., founder and CEO of Emmaus Medical. “As a physician and researcher, I have dedicated much of my life to treating patients with sickle cell disease and to finding a widely available, safe and effective treatment to help them. With the completion of our patient visits for this trial, we are now potentially one step closer to bringing the first new treatment to patients in more than 20 years.”
L-glutamine treatment for sickle cell anemia and sickle β0-thalassemia is a patent protected treatment, for which research has been led by Dr. Niihara and investigators at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center. L-glutamine for the treatment of sickle cell disease has received Fast Track designation from the U.S. Food and Drug Administration (FDA), as well as Orphan Drug designation from both the FDA and the European Commission.
About Emmaus Medical, Inc.
Founded in 2000, Emmaus Medical, Inc. is a biopharmaceutical company engaged in the discovery, development and commercialization of innovative and cost-effective treatments and therapies primarily for rare and orphan diseases, and subsidiary of Emmaus Life Sciences, Inc. The company has completed all patient visits for its Phase 3 clinical trial for a treatment for sickle cell disease and has entered into a collaborative agreement for the research, development and commercialization of regenerative medicine products.
For more information, please visit www.emmausmedical.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 for the year ended December 31, 2012 and Quarterly Reports on Form 10-Q the quarters ended March 31, 2013, June 30, 2013 and September 30, 2013. 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.