Navigation Links
Curemark Announces Further Expansion of Clinical Sites For Its Phase 3 Clinical Trial for Children with Autism – The Blüm Study
Date:2/23/2017

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 three new sites. These new sites are in addition to the 30 clinical sites already enrolling children across the United States.

“There are currently no approved drugs that address the core symptoms of autism,” said Dr. Joan Fallon, founder and CEO of Curemark. “Making our clinical trial available to as many children across the United States as possible, is an important step toward seeking FDA approval of CM-AT.”

This 14-week, double-blind, randomized, placebo-controlled Phase 3 study is being conducted to determine if CM-AT may help improve core and non-core symptoms of Autism. CM-AT, which has been granted Fast Track designation by FDA, 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 three new Blüm trial sites are:

Colorado
IMMUNOe Research Centers (Thornton)

Florida
Segal Institute for Clinical Research (Miami)

New Jersey
Children's Specialized Hospital (Egg Harbor Township)

For more information about the Blüm Study or to find a Clinical Trial Site near you, visit: http://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 33 sites across the United States. For additional information, please see: http://www.blumstudy.com.

Safe Harbor
This press release, as well as information about the Blüm Study located at http://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.

# # #

Read the full story at http://www.prweb.com/releases/2017/02/prweb14088362.htm.


'/>"/>
Source: PRWeb
Copyright©2017 Vocus, Inc.
All rights reserved


Related medicine news :

1. Curemark Celebrates World Autism Awareness Day as a Visionary Sponsor of Several Autism Speaks 2016 Walks
2. Curemark’s Dr. Joan Fallon Honored at Fred and Adele Astaire Awards for Her Work in Autism
3. Dr. Joan Fallon, Founder & CEO of Curemark, Named One of the 2016 PM360 Elite 100
4. Diet Doc’s Prescription Hormone Diets & Weight Loss Plans Announces New Clean Eating Diet Plans to Slim the Waistline While Reducing the Risk for Colorectal Cancer
5. EmpowHER’s Michelle King Robson Announces Launch of HER Radio – Exploring all things Woman
6. Innovations with Ed Begley, Jr. Announces New Episode Airing November 14, 2013 via Discovery Channel
7. T.E.N. Announces Winners of the ISE® North America Awards
8. AED.com Announces That All Employees Now Carry a Personal AED
9. Phoenix Treatment Center Announces New Video Explaining Its Services for Drug, Alcohol Addiction
10. Innovaacom Announces November Launch of New Hospital-Based Physician Training Program
11. Coffee Beanery Announces Grand Opening of New Store in Memorial City Mall
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2017)... Bethesda, Md (PRWEB) , ... June 26, 2017 ... ... largest orthopaedic group in the country, today announced the hiring of Richard Robinson ... years of diverse leadership and operations experience, with a proven track record of ...
(Date:6/26/2017)... ... ... LARKR™ , an innovative new smartphone app providing on-demand talk therapy, ... join its online treatment platform. , Launching in just a few days, LARKR ... of people in need nationwide, and to supplement their traditional practices. Joining this network ...
(Date:6/26/2017)... ... 26, 2017 , ... New patients with missing teeth in Fitchburg, ... a referral. Dr. Cotey is a trusted dentist who has placed many dental implants ... Patients with missing teeth in Fitchburg, WI, are encouraged to find out if they ...
(Date:6/25/2017)... ... ... Republicans in the United States Senate on Thursday released their version of bill ... significantly from the American Health Care Act, which the House passed in May, so ... have to take up the Senate version as-is, if it passes. , The following ...
(Date:6/25/2017)... ... June 25, 2017 , ... With a heatwave currently bearing down on Northern California pushing temperatures ... pool. Being swimsuit ready is easy with laser hair removal. , The process of ... a burdensome routine when all you want to do is get out, dive in and ...
Breaking Medicine News(10 mins):
(Date:6/14/2017)... , June 14, 2017  In 2016, ... Creative Startups pitch competition and came away with ... platform is described by Forbes as "entering the life ... Medical Association as teaching "empathy to medical professionals in ... startup was recently named a finalist for the Department ...
(Date:6/10/2017)... Burchfield, DPM, is recognized by Continental Who,s Who as a Pinnacle ... Alabama . Dr. Burchfield serves as a ... 20 years of experience, as well as expertise in the areas ... "The podiatry professional   ... welcome you to his practice," the company,s website states. "We want ...
(Date:6/8/2017)... , June 8, 2017   Responding to Heath ... and the death of singer Chris Cornell in ... Rights International offers a free online psychiatric ... consumers and families about psychotropic drug risks. ... who died from an accidental overdose, has called for tighter ...
Breaking Medicine Technology: