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:
ArizonaThe University of Arizona Pediatric Multidisciplinary Research Unit (Tucson) Southwest Autism Research & Resource Center (Phoenix)
ArkansasArkansas Children's Research Institute (Little Rock)
CaliforniaN.R.C. Research Institute (Orange)UC Davis MIND Institute (Sacramento) University of California, San Francisco (San Francisco)
ColoradoIMMUNOe Research Centers (Centennial)
ConnecticutYale Child Study Center (New Haven)
FloridaLake Mary Pediatrics (Orange City) A.P.G. Research, LLC (Orlando)
IndianaResearch Institute of Deaconess Clinic (Evansville)
LouisianaLake Charles Clinical Trials (Lake Charles) LSU Health Shreveport (Shreveport)
MichiganDetroit Clinical Research Center, PC (Bingham Farms)
New JerseyChildren's Specialized Hospital (Toms River) Clinical Research Center of New Jersey, LLC (Voorhees)
New MexicoLovelace Scientific Resources, Inc. (Albuquerque)
New YorkMontefiore Medical Center, Autism & Obsessive Compulsive Spectrum Program (Bronx)Richmond Behavioral Associates (Staten Island)
North CarolinaDuke Center for Autism & Brain Development (Durham)
OhioCleveland Clinic Children's Hospital (Cleveland) The University of Toledo and the ProMedica Toledo Children's Hospital (Toledo)
Rhode IslandOmega Medical Research (Warwick)
South CarolinaCarolina Clinical Trials, Inc. (Charleston)
TennesseeVanderbilt University Medical Center (Nashville)
TexasMcGovern Medical School at The University of Texas Health Science Center at Houston (Houston)
UtahEricksen Research & Development (Clinton)
VirginiaNeuroScience, 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, LLCCuremark, 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 StudyTMCM-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.
Safe HarborThis 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.
These forward-looking statements are neither promises nor guarantees, but involve risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements. These risks and uncertainties include, among other things: (i) uncertainties inherent in research and development; (ii) the ability to meet anticipated clinical trial commencement and completion dates and regulatory submission dates; (iii) the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; (iv) whether and when any New Drug Applications may be filed with any jurisdiction for CM-AT; (v) whether and when any such applications may be approved by regulatory authorities, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; (vi) decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of CM-AT; and (vii) competitive developments.
Readers should not place undue reliance on any forward-looking statements, which speak only as of the date they are made. Except as may be required by law, Curemark, LLC undertakes no obligation to update any forward-looking statements contained in this press release to reflect any change in Curemark, LLC's expectations or any change in information, events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
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"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."
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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:
ArizonaThe University of Arizona Pediatric Multidisciplinary Research Unit (Tucson) Southwest Autism Research & Resource Center (Phoenix)
ArkansasArkansas Children's Research Institute (Little Rock)
CaliforniaN.R.C. Research Institute (Orange)UC Davis MIND Institute (Sacramento) University of California, San Francisco (San Francisco)
ColoradoIMMUNOe Research Centers (Centennial)
ConnecticutYale Child Study Center (New Haven)
FloridaLake Mary Pediatrics (Orange City) A.P.G. Research, LLC (Orlando)
IndianaResearch Institute of Deaconess Clinic (Evansville)
LouisianaLake Charles Clinical Trials (Lake Charles) LSU Health Shreveport (Shreveport)
MichiganDetroit Clinical Research Center, PC (Bingham Farms)
New JerseyChildren's Specialized Hospital (Toms River) Clinical Research Center of New Jersey, LLC (Voorhees)
New MexicoLovelace Scientific Resources, Inc. (Albuquerque)
New YorkMontefiore Medical Center, Autism & Obsessive Compulsive Spectrum Program (Bronx)Richmond Behavioral Associates (Staten Island)
North CarolinaDuke Center for Autism & Brain Development (Durham)
OhioCleveland Clinic Children's Hospital (Cleveland) The University of Toledo and the ProMedica Toledo Children's Hospital (Toledo)
Rhode IslandOmega Medical Research (Warwick)
South CarolinaCarolina Clinical Trials, Inc. (Charleston)
TennesseeVanderbilt University Medical Center (Nashville)
TexasMcGovern Medical School at The University of Texas Health Science Center at Houston (Houston)
UtahEricksen Research & Development (Clinton)
VirginiaNeuroScience, 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, LLCCuremark, 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 StudyTMCM-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.
Safe HarborThis 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.
These forward-looking statements are neither promises nor guarantees, but involve risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements. These risks and uncertainties include, among other things: (i) uncertainties inherent in research and development; (ii) the ability to meet anticipated clinical trial commencement and completion dates and regulatory submission dates; (iii) the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; (iv) whether and when any New Drug Applications may be filed with any jurisdiction for CM-AT; (v) whether and when any such applications may be approved by regulatory authorities, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; (vi) decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of CM-AT; and (vii) competitive developments.
Readers should not place undue reliance on any forward-looking statements, which speak only as of the date they are made. Except as may be required by law, Curemark, LLC undertakes no obligation to update any forward-looking statements contained in this press release to reflect any change in Curemark, LLC's expectations or any change in information, events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
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SOURCE Curemark, LLC
