digestion pill for AU put on Fast track by FDA

[Guest guest]

http://www.prnewswire.com/news-releases/curemark-cm-at-autism-treatment-granted-\

fda-fast-track-status-84951682.html

Curemark CM-AT Autism Treatment Granted FDA Fast Track Status

RYE, N.Y., Feb. 22 /PRNewswire/ -- Curemark LLC, (www.curemark.com), a

drug research and development company focused on the treatment of

neurological diseases, announced that its CM-AT autism treatment, now

in Phase III clinical trials, has been designated as a Fast Track drug

by the U.S. Food and Drug Administration (FDA).

Fast Track is a process designed to facilitate the development and

expedite the review of drugs to treat serious diseases and those that

fill an unmet medical need, providing a therapy where none exists or

are potentially superior to existing therapy, according to the FDA Web

site. Fast Track designation provides for early and frequent

communication between the FDA and the drug company to resolve

questions and issues quickly, obtaining an expedited review and faster

access by patients.

" We are very excited about the FDA's Fast Track designation for

CM-AT, " said Dr. Joan Fallon, Curemark founder and CEO. " We're making

rapid progress with the CM-AT trials and being named as a Fast Track

drug means that we potentially can get our autism treatment to market

faster for the children and parents who will benefit from it. "

CM-AT is based on Dr. Fallon's breakthrough research that showed

enzyme deficiencies in autistic children, resulting in an inability to

digest protein. The inability to digest protein affects the

production of amino acids, the building blocks of chemicals essential

for brain function. CM-AT will be one of the first therapies to

address the underlying physiology of autism, rather than just treat

its symptoms.

Curemark is conducting Phase III clinical trials for CM-AT at 12 sites

across the country with a total 170 children. Ten of the sites are

now enrolling patients. FL,NC PA TX

Here is the link for where the clinic trials are being held and how to

sign up plus I copy pasted part of page

http://www.clinicaltrials.gov/ct2/show/NCT00881452?term=curemark & rank=1

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881452

Contacts

Contact: Walsh, RN MSN kristin.walsh@...

Locations

United States, Arizona

Southwest Autism Research and Resource Center Recruiting

Phoenix, Arizona, United States, 85006

Contact: Brautigam, MPH

sbrautigam@...

Principal Investigator: , PhD

United States, California

University of California, , M.I.N.D. Institute Not yet recruiting

Sacramento, California, United States, 95817

Contact: Kindra Root, CCRC

kindra.root@...

Principal Investigator: Randi Hagerman, MD

United States, Florida

Lake Pediatrics Recruiting

Orange City, Florida, United States, 32763

Contact: Heidi , RN cclinical2@...

Contact: Liz Vieco, LPN cclinical1@...

Principal Investigator: Miles Landis, MD

United States, Indiana

Indiana University, Purdue University Indianapolis Withdrawn

Indianapolis, Indiana, United States, 46202

United States, Louisiana

Louisiana State University Health Science Center Recruiting

Shreveport, Louisiana, United States, 71103

Contact: Hoffman, BS khoff2@...

Principal Investigator: Anita Kablinger, MD

United States, New York

Mount Sinai School of Medicine Recruiting

Ny, New York, United States, 10029

Contact: Pepa, BA lauren.pepa@...

Principal Investigator: Kolevzon, MD

United States, North Carolina

University of North Carolina Recruiting

Chapel Hill, North Carolina, United States, 27514

Contact: Lindsey Hazzard, MSW lhazzard@...

Principal Investigator: Lin Sikich, MD

United States, Ohio

Ohio State University Recruiting

Columbus, Ohio, United States, 43210

Contact: Tori Stromp, BS Tori.Stromp@...

Principal Investigator: Eugene Arnold, MD

United States, Pennsylvania

University of Pittsburgh Not yet recruiting

Pittsburgh, Pennsylvania, United States, 15260

Contact: McAuliffe-Belin, M.Ed

mcauliffebellinsj@...

Principal Investigator: Handen, MD

Drexel University Recruiting

Philadelphia, Pennsylvania, United States, 19124

Contact: Lech, RN .Lech@...

Principal Investigator: Malone, MD

Hershey Medical Center Recruiting

Hershey, Pennsylvania, United States, 17033

Contact: Vallati, LPN jvallati@...

Principal Investigator: Jeanette Ramer, MD

United States, Texas

University of Texas, Houston Recruiting

Houston, Texas, United States, 77030

Contact: Rosleen Mansour, MA

Rosleen.Mansour@...

Principal Investigator: Deborah Pearson, PhD