Navigation Links
Emmaus CEO Yutaka Niihara, M.D., Issues Statement In Connection with Status of Company's Phase III FDA Sickle Cell Treatment Trials
Date:11/19/2012

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.

Contacts:

Media:
Lori Teranishi for Emmaus Medical, Inc.
415-981-1964
lteranishi@iqprinc.com

Investors:
Roger Pondel for Emmaus Medical, Inc.
310-279-5965
rpondel@pondel.com


'/>"/>
SOURCE Emmaus Medical, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. European Commission Grants Orphan Medicinal Product Designation for Emmaus Medicals Sickle Cell Treatment
2. Emmaus Medical Marks Progression of Phase 3 Sickle Cell Disease Clinical Trial During Sickle Cell Awareness Month
3. Synthetic Biologics Appoints Carol Reed, M.D., as Senior Vice President of Clinical & Regulatory Affairs
4. Nile Therapeutics Appoints Darlene Horton, M.D., as Chief Medical Officer
5. Nile Therapeutics Promotes Darlene Horton, M.D., to Chief Executive Officer and Director
6. NIH Director Francis S. Collins, M.D., Ph.D. Selected as 2012 Pro Bono Humanum Honoree by Prix Galien USA
7. Sequenom Welcomes Myla Lai-Goldman, M.D., To Board Of Directors
8. Icahn Issues Statement Regarding Amylin Pharmaceuticals
9. Patient Advocate Foundation Announces New Co-Pay Relief (CPR) Offerings for Patients Facing Health Issues Due to Electrolyte Imbalance
10. U.S. Patent Office Issues Sixth Patent Covering Zero-Footprint Medical Image Viewers to Heart Imaging Technologies, LLC
11. Upcoming Presentations on Global Market Access Issues and Trends in Health Economics and Outcomes Research at ISPOR 2012 by Novel Health Strategies
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/7/2017)... 7, 2017 NuvoAir (formerly called Pond ... today a partnership with Novartis Pharma AG to distribute NuvoAir,s ... as the leading mobile spirometry platform and Novartis, commitment to ... ... ...
(Date:9/7/2017)... BioLife Solutions , Inc. (NASDAQ: BLFS ), the ... and tissue hypothermic storage and cryopreservation freeze ... and CEO, will be presenting at two investment conferences in ... th Annual Global Investment Conference on Tuesday, September 12th, ... conference is being held at the New York Palace Hotel ...
(Date:9/6/2017)... Sept. 6, 2017  Medical professionals are ... skills while treating their patients. Medical simulations ... without involving patients. Simulation provides a safe ... carry out procedures, refine techniques and build ... of new technology, such as augmented reality, ...
Breaking Medicine Technology:
(Date:9/19/2017)... ... September 19, 2017 , ... ... brand, developed by ACPG Laboratories, is coming soon to RonnieColemanNutrition.com. , ACPG ... El Naturalista is a trusted, well-respected brand reliant on the healing properties of ...
(Date:9/19/2017)... ... ... First Choice Emergency Room , the largest network of independent freestanding emergency ... of its Pflugerville- FM 685 facility. , “We are pleased to announce Dr. ... said Dr. Stephen Van Roekel, Reginal Medical Officer of First Choice Emergency Room – ...
(Date:9/19/2017)... ... 19, 2017 , ... Inc. magazine ranked Endo-Systems ... the nation's fastest-growing private companies. The list represents a unique look at the ... and midsized businesses. Endo-Systems is a leading B2B distributor of today’s most scientifically ...
(Date:9/18/2017)... ... September 19, 2017 , ... Sarantos For ... Book This December , Sarantos is proud to be the 1st (and continues to ... new song release. A new song, music video, book chapter and behind the scenes ...
(Date:9/18/2017)... ... September 18, 2017 , ... Aegis Therapies, a national ... the executive team adding a Chief Financial Officer following their announcement on January ... will support the strategic growth strategy Aegis has defined for the next several ...
Breaking Medicine News(10 mins):