In conjunction with Sickle Cell Awareness Month, Emmaus Medical, Inc., a specialty pharmaceutical and regenerative medicine technology company, announced that its U.S. Phase III clinical trial to study L-Glutamine as a treatment for sickle cell disease is nearing target enrollment completion, with investigation now underway at more than 30 clinical study sites throughout the U.S. For a complete list of the clinical trial sites please visit http://www.clinicaltrials.gov (NCT01179217).
With the clinical trial already in progress, Emmaus Medical also announced that an interim subset of data was analyzed and submitted to the U.S. Food and Drug Administration (FDA) by an independent committee. Currently, more than 190 of up to 225 patients are enrolled in the trial, and the company said it expects final data collection to be complete in 2013.
"During Sickle Cell Awareness month, we are reminded of the pain and suffering of those affected by this debilitating disease and the need for a widely available treatment," said Yutaka Niihara, M.D., MPH, founder and CEO of Emmaus Medical. "Today, we believe Emmaus is the only company with a Phase III trial underway for a new sickle cell treatment. With research grants and through the generous support of friends and family over the past 20 years, we have progressed to the point where we are confident in our treatment and hopeful that it will be in the hands of patients worldwide in the not too distant future."
patent-protected treatment, whose research was led by Dr. Niihara and
investigators at the Los Angeles Biomedical Research Institute at Harbor-UCLA
Medical Center, has orphan drug designation and Fast Track status in the United
States and Orphan Medicinal Product designation in the European Union.
its research, Emmaus will be participating in the 40th Annual Sickle
Cell Disease Association of America National Convention, from September 25 to
29 at the Baltimore Marriot Waterfront Hotel in Baltimore.
SOURCE Emmaus Medical, Inc.