Emmaus CEO Yutaka Niihara, M.D., Issues Statement In Connection with Status of Company’s Phase III FDA Sickle Cell Treatment Trials
TORRANCE, Calif., Nov. 19, 2012 /PRNewswire/ — Following a meeting on November 5, 2012 with the U.S. Food & Drug Administration (FDA), Dr. Yutaka Niihara offered the following remarks:
“The FDA’s review group unanimously recommended that we proceed to complete our Phase III trial without any modification to the protocol. The trial is directed to study L-glutamine as a treatment for sickle cell disease.
“We currently have 220 patients enrolled at 32 study sites throughout the United States. We will continue enrollment until the end of 2012, with an objective to complete the trial in 2013.
“The FDA’s recommendation on proceeding to complete the trial follows the preliminary review of a subset of data from the Phase III clinical trial that was completed by an independent third party in August of this year. Emmaus received its initial authorization from the FDA to begin the Phase III trial in August 2009, with the first patient enrolled in mid-2010.
“We continue to believe that Emmaus is the only company with a Phase III trial underway for a new sickle cell treatment. With research grants and through the support of friends, family and private investors over the past 20 years, we have progressed to the point where we are confident in our treatment and hopeful it will be in the hands of patients worldwide in the not too distant future.”
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.
Lori Teranishi for Emmaus Medical, Inc.
Roger Pondel for Emmaus Medical, Inc.
SOURCE Emmaus Medical, Inc.