Emmaus Medical Marks Progression of Phase 3 Sickle Cell Disease Clinical Trial During Sickle Cell Awareness Month
- Study Now Underway at More than 30 Clinical Sites Throughout U.S.; Trial Enrollment Nears Completion
- Interim Data Analysis Submitted to FDA
- Company to participate in 40th Annual Sickle Cell Disease Association of America National Convention
TORRANCE, Calif., Sept. 13, 2012 /PRNewswire/ -- 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."
Emmaus' 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.
To discuss 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.
About Sickle Cell Disease
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. An estimated 200,000 people in the United States and the Europe Union, and four to five million people worldwide, primarily in Latin America and Africa, are afflicted. Currently, there is no universal cure for sickle cell disease.
About Emmaus Medical, Inc.
Founded in 2000, Emmaus Medical, Inc. is a specialty pharmaceutical company, and subsidiary of Emmaus Life Sciences, Inc., dedicated to the discovery, development and commercialization of innovative and cost-effective treatments and therapies for rare diseases. The company is completing its Phase III 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 technology products. For more information, please visit www.emmausmedical.com and www.nutrestore.com.
This press release contains forward-looking statements that involve substantial risks and uncertainties. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include, without limitation, statements regarding completion of the Phase III clinical trial in 2013, the potential for the L-Glutamine treatment for sickle cell disease, the timing, progress and anticipated results of the clinical development of the L-Glutamine treatment for sickle cell disease, Emmaus' ability to fund the development of the L-Glutamine treatment to completion, as well as Emmaus' plans and objectives. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Various important factors could cause actual results or events to differ materially from the forward-looking statements that we make. Such factors include, among others, risks that the results of clinical trials will not support our claims or beliefs concerning the effectiveness of the L-Glutamine treatment or any of our other product candidates, our ability to finance the development of our product candidates, regulatory risks, including our ability to obtain FDA, European Commission and other regulatory approval for L-Glutamine treatment for sickle-cell disease, our ability to commercialize our L-Glutamine treatment for sickle cell disease, and our reliance on third party researchers and other collaborators. 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, 2011. 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.
Lori Teranishi for Emmaus Medical, Inc.
Matt Sheldon for Emmaus Medical, Inc.
Clinical Trial Information:
Dr. Henry Macan or Dr. Rafael Razon
SOURCE Emmaus Medical, Inc.