Navigation Links
Curemark Receives Investigational New Drug Clearance for CM-AT for Autism
Date:3/25/2009

Phase III Trial to Begin

RYE, N.Y., March 25 /PRNewswire/ -- Curemark, LLC, a drug research and development company focused on the treatment of neurological diseases, announced today that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application to initiate its pivotal Phase III clinical trial of CM-AT for the treatment of autism.

The company expects to begin Phase III clinical trials at multiple sites across the US in the second quarter of 2009. As part of this IND, the FDA has agreed that Curemark may proceed directly into pivotal Phase III clinical trials in patients with autism. The FDA has reviewed the quality, safety and efficacy data generated by Curemark in pediatric patients with autism. In addition, the FDA has provided written guidance on the trial protocol.

"FDA clearance of the CM-AT IND for the pivotal Phase III trial is an important milestone for Curemark," commented Dr. Joan Fallon, Curemark's CEO. "With 1 in 150 children diagnosed with autism, we have children who are suffering. We are very excited about the opportunity to enter a Phase III trial for this ever-growing population of children."

About CM-AT

As part of Curemark's ENCAPTASE(TM) technology platform, CM-AT is based upon the observation that many children with autism do not digest protein. CM-AT is a proprietary therapy formulated to be released in the small intestine of children with autism. Designed as an easily utilized powder taken three times a day, CM-AT was developed with the children in the forefront. The administration of CM-AT with meals allows for an increase in protein digestion thus potentially reducing allergy and increasing the availability of essential amino acids. With proper protein digestion in a subset of children with autism, the need for protein restricted diets, such as gluten-free and casein-free diets, to which many children with autism have become accustomed, may no longer be necessary. Being able to digest protein rather than avoid it will allow children with autism greater access to the building blocks for the manufacture of new proteins such as neurotransmitters. A partial or complete lack of protein digestion could further lead to other gastrointestinal and digestive dysfunctions.

About CUREMARK LLC

Curemark is a drug research and development company focused on the treatment of neurological and other diseases especially those with dysautonomic components by addressing certain key gastrointestinal/pancreatic secretory deficiencies. The company's initial products are based upon breakthrough observations by its founder, Dr. Joan Fallon, which revealed a lack of protein digestion in children with autism and ADHD. To learn more about our innovative science, visit www.curemark.com

This news release contains forward-looking statements that involve risks and uncertainties that could cause our actual results and experiences to differ materially from anticipated results and expectations expressed in such forward-looking statement. These forward-looking statements include, without limitation, statements regarding the mechanism of action of CM-AT, its potential advantages, its potential for use in treating autism, as well as the timing, progress and anticipated results of the clinical development and regulatory processes concerning CM-AT. These statements are based on our current beliefs and expectations as to such future outcomes, and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a material difference include, among others, risks that the results of clinical trials will not support our claims or beliefs concerning the effectiveness of CM-AT, our ability to finance our development of CM-AT, regulatory risks, and our reliance on third party researchers and other collaborators. We assume no obligation to update these statements, except as required by law.


'/>"/>
SOURCE Curemark, LLC
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Curemark CEO Presents Autism Findings at Prestigious Neurobiology Conference at Oxford
2. Curemark Appoints Dr. Elisa J. Zinberg as Vice President of Operations
3. Curemark to Present at the 2008 Life Sciences & Healthcare Venture Summit 2008
4. Lake Elsinore Family Caregiver Receives Free Power Wheelchair From The SCOOTER Store
5. DaVita Receives Civil Complaint
6. Ranbaxy Receives Tentative Approval to Manufacture and Market Galantamine Tablets on an Exclusive Basis
7. Watson Receives First FDA Approval for Manufacturing Product at Its Goa, India Facility
8. Edwards Lifesciences Receives CE Mark for Edwards SAPIEN Transcatheter Heart Valve
9. PainCare Receives $14.4 Million in Cash From Completed Sale of South Florida Ambulatory Surgery Centers
10. UT Southwesterns obesity research receives $22 million NIH Roadmap grant
11. Temple Emergency Medicine receives $1.8M to find best MRSA treatment
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... , ... October 13, 2017 , ... Apple Rehab ... services, staged a mock evacuation of the facility as part of a disaster drill ... Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... ... October 13, 2017 , ... Global Healthcare Management’s 4th ... Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s CEO, ... The fun run is geared towards children of all ages; it is a non-competitive, ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the Mountains to the ... save lost souls in the Philippines. “The Journey: From the Mountains to the Mission ... of the Bible. She has taught all ages and currently teaches a class of ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest ... its plans to open a flagship location in Covington, LA at 401 N. U.S. ... Go store next to Office Depot in the Holiday Square shopping center. Its location ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... leader in post-acute health care, have expanded their existing home health joint venture ... , AccentCare has been operating a joint venture home health company with Asante, ...
Breaking Medicine News(10 mins):
(Date:9/18/2017)... , Sept. 18, 2017  PMD Healthcare of ... Pharmacy of Kalamazoo, Mich. , have ... service that expedites and streamlines patient and provider access ... 2.0, and wellness management services.  ... used to measure lung function for a variety of ...
(Date:9/13/2017)... 13, 2017   OrthoAtlanta has been named the ... Host Committee (AFHC) for the 2018 College Football Playoff (CFP) ... at Mercedes-Benz Stadium in Atlanta, Georgia . ... "I,m In" campaign, participating in many activities leading up to, ... ...
(Date:9/12/2017)... , Sept. 12, 2017  Consumer reviews on the independent review ... as the number one company for hearing aids, ranking it higher ... other brands. ... Named #1 by Consumers For Hearing Aids ... Embrace Hearing is an online store that provides high performance, state-of-the-art, ...
Breaking Medicine Technology: