Reduction in the Frequency of Sickle Cell Crisis, Frequency in Hospitalizations, Hospital Days and Fewer Cases of Acute Chest Syndrome Highlighted in Abstract
TORRANCE, Calif., February 2, 2015 – Emmaus Life Sciences, Inc. (the “Company,” or “Emmaus”), today announced that a summary of the results of the Company’s Phase 3 clinical trial of its patented oral pharmaceutical grade L-glutamine (PGLG) treatment for sickle cell anemia and sickle beta-0 thalassemia was included in the American Society of Hematology’s official 2015 Highlights of ASH, a two-day seminar program held in six cities across North America during January. These Phase 3 results were initially presented in December 2014 at the ASH Annual Meeting.
The Phase 3 multi-center, double blind clinical trial studied the efficacy and safety of PGLG for sickle cell disease (SCD) in 230 pediatric patients as young as five years old and adults. Study participants were randomized to receive daily PGLG (152 patients) or placebo (78 patients) for 48 weeks, after which treatment levels were tapered to zero. Researchers observed that patients who received PGLG experienced fewer painful crises (3 vs. 4 events during the study period, a 25% reduction) and a longer time to a pain crisis than patients receiving placebo. Treated patients were also less likely to be hospitalized for their condition (2 vs. 3 events during the study period, a 33% reduction) and spent less time in the hospital for these events (6.5 vs. 11 days, a 41% reduction) than those receiving placebo. The percentage of patients experiencing acute chest syndrome, a severe complication of SCD, was less than half among the PGLG group as compared to the placebo group (11.9% vs. 26.9%, or 58% fewer cases). The treatment was well tolerated, as safety profiles were similar among the PGLG and placebo groups.
“We are pleased that the positive safety and efficacy results of our Phase 3 trial of PGLG in treating sickle cell patients has been included in the Highlights of ASH program,” said Dr. Yutaka Niihara, M.D., M.P.H., founder and CEO of Emmaus Life Sciences. “We believe the results demonstrate a well-tolerated safety profile that has the potential to help adult and pediatric patients who are in need of new therapies to treat SCD.”
The Company’s research on sickle cell disease and sickle beta-0 thalassemia was initiated by Dr. Niihara at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center. The therapy has Orphan Drug designation in the U.S. and Europe and Fast Track designation from the FDA.
About Emmaus Life Sciences
Emmaus Life Sciences is dedicated to the discovery, development and commercialization of innovative treatments and therapies for rare diseases. 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 for the year ended December 31, 2013 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.