RYE, N.Y., Sept. 22, 2016 /PRNewswire/ -- Curemark, LLC announced today that the Blüm Study, a Phase 3 clinical trial to evaluate the safety and efficacy of CM-AT in children aged 3-8 with Autism, is now enrolling at 30 clinical sites across the United States.
"There are limited medical treatment options available for children with Autism, particularly for children aged 3-8, which is when Autism is generally diagnosed," said Dr. Joan Fallon, CEO of Curemark. "CM-AT has the potential to serve this clear unmet medical need. With all 30 of our clinical trial sites now enrolling across the United States, we look forward to the trial's completion and submitting our New Drug Application for CM-AT."
This 14-week, double-blind, randomized, placebo-controlled Phase 3 study is designed to determine if CM-AT may help improve core and non-core symptoms of Autism. CM-AT is designed to enhance protein digestion thereby potentially restoring the pool of essential amino acids. Essential amino acids play a critical role in the expression of several genes important to neurological function and serve as precursors to key neurotransmitters such as serotonin and dopamine.
The Blüm trial sites in this ongoing Phase 3 study of CM-AT include:
The University of Arizona Pediatric Multidisciplinary Research Unit (Tucson)
Southwest Autism Research & Resource Center (Phoenix)
Arkansas Children's Research Institute (Little Rock)
N.R.C. Research Institute (Orange)
UC Davis MIND Institute (Sacramento)
University of California, San Francisco (San Francisco)
IMMUNOe Research Centers (Centennial)
Yale Child Study Center (New Haven)
Lake Mary Pediatrics (Orange City)
A.P.G. Research, LLC (Orlando)
Research Institute of Deaconess Clinic (Evansville)
Lake Charles Clinical Trials (Lake Charles)
LSU Health Shreveport (Shreveport)
Detroit Clinical Research Center, PC (Bingham Farms)
Children's Specialized Hospital (Toms River)
Clinical Research Center of New Jersey, LLC (Voorhees)
Lovelace Scientific Resources, Inc. (Albuquerque)
Montefiore Medical Center, Autism & Obsessive Compulsive Spectrum Program (Bronx)
Richmond Behavioral Associates (Staten Island)
Duke Center for Autism & Brain Development (Durham)
Cleveland Clinic Children's Hospital (Cleveland)
The University of Toledo and the ProMedica Toledo Children's Hospital (Toledo)
Omega Medical Research (Warwick)
Carolina Clinical Trials, Inc. (Charleston)
Vanderbilt University Medical Center (Nashville)
McGovern Medical School at The University of Texas Health Science Center at Houston (Houston)
Ericksen Research & Development (Clinton)
NeuroScience, Inc. (Herndon)
Carilion Clinic (Roanoke)
Charlottesville: see www.blumstudy.com for contact information
For more information about the Blüm Study or to find a Clinical Trial Site near you, visit: www.blumstudy.com.
About Curemark, LLC
Curemark, LLC is a clinical-stage biopharmaceutical company focused on developing novel therapies for the treatment of neurological disorders.
Curemark's pipeline includes preclinical and clinical-stage programs for the treatment of Autism, ADHD, addiction, Schizophrenia and Parkinson's disease. For additional information, please visit our website at http://www.curemark.com or follow @curemark on Twitter.
About CM-AT & The Blüm StudyTM
CM-AT, Curemark's lead drug candidate, has been granted "Fast Track" designation by the U.S. Food and Drug Administration for the investigation of Autism. The company is currently enrolling a Phase 3 double-blind, randomized, placebo-controlled clinical trial (known as the Blüm Study) to examine the effect of CM-AT in children ages 3-8 with Autism. The trial is enrolling at 30 sites across the United States. For additional information, please see: http://www.blumstudy.com.
This press release, as well as information about the Blüm Study located at www.blumstudy.com, includes forward-looking statements. These forward-looking statements include statements regarding (i) the development of Curemark, LLC's lead drug candidate, CM-AT, for Autism, (ii) CM-AT's potential to serve medical needs, (iii) the anticipated completion of the Blüm Study to evaluate CM-AT, (iv) the anticipated submission of a New Drug Application for CM-AT and (v) CM-AT's mechanism of action. In some cases, forward-look statements can be identified by words such as "may," "will," "should," "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," "predict," "potential," the negative of such words, variations of such words and similar expressions, although not all forward-looking statements contain these identifying words.
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Last updated on: 23/09/2016
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