|Emmaus Medical, Inc., a specialty pharmaceutical and regenerative medicine technology company, has announced that it is nearing to complete enrollment target for US phase III clinical trial to study L-Glutamine as a treatment for sickle cell disease. Currently, more than 190 of up to 225 patients are enrolled in the trial, and expects final data collection to be complete in 2013.
Emmaus will be participating in the 40 th Annual Sickle Cell Disease Association of America National Convention, from September 25 to 29 at the Baltimore Marriot Waterfront Hotel in Baltimore.
“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, MD, 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.”
With the clinical trial already in progress, Emmaus Medical also announced that an interim subset of data was analyzed and submitted to the US Food and Drug Administration (FDA) by an independent committee. The invetigation is now underway at more than 30 clinical study sites throughout the US.
Emmaus’ patent-protected treatment, whose research was led by Dr Niihara and investigators at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Centre, has orphan drug designation and Fast Track status in the United States and Orphan Medicinal Product designation in the European Union.
Sickle cell disease is an inherited blood disorder causing red blood cells to become oxidized, forming rigid and sickled shaped cells that block small blood vessels. The condition causes debilitating pain crises and organ damages that can lead to death at an early age. Currently, there is no universal cure for sickle cell disease.
Emmaus Medical, Inc. a subsidiary of Emmaus Life Sciences, Inc., dedicated to the discovery, development and commercialization of innovative and cost-effective treatments and therapies for rare diseases.