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 ch
'/>"/>

SOURCE Curemark, LLC
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

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:9/22/2014)... new study pulls back the curtain on one of ... payment and income between physicians who perform operations, procedures ... to perception, the research indicates, the physician payment system ... procedure-performing doctors. , The new findings counter the widely ... minute explains why doctors who perform procedures often earn ...
(Date:9/22/2014)... HealthDay Reporter MONDAY, Sept. 22, 2014 (HealthDay ... care units (NICU) set up private rooms for parents to ... Researchers at one children,s hospital found that preemies gained weight ... NICU switched from the traditional "open-bay" layout to private rooms ... the journal Pediatrics , add to evidence that private ...
(Date:9/22/2014)... Up to 40 percent of patients undergoing breast cancer ... remove all the cancerous tissue in the initial operation. ... successfully tested a tool they developed that will help ... thereby decreasing the chances for repeat operations. ... of September 22, 2014 in the Proceedings of ...
(Date:9/22/2014)... ON (September 22, 2014) McMaster scientists have found ... new class of antibiotics. , Although dozens of ... at how a certain part of bacteria are created, ... it. , The discovery is important as there ... making the cures for infections ineffective. The World Health ...
(Date:9/22/2014)... New York, US (PRWEB) September 22, 2014 ... Heartbeat Experts’ perspectives on stakeholder management needs for the ... speak with Heartbeat Experts on stakeholder strategies for any ... clinically meaningful points of differentiation within an increasingly crowded ... , The impact of identifying community-based thought ...
Breaking Medicine News(10 mins):Health News:Think the system for paying US doctors is rigged to favor surgeons? Study may surprise you 2Health News:Think the system for paying US doctors is rigged to favor surgeons? Study may surprise you 3Health News:Think the system for paying US doctors is rigged to favor surgeons? Study may surprise you 4Health News:Newborn ICUs With Private Family Rooms Benefit Preemies: Study 2Health News:Newborn ICUs With Private Family Rooms Benefit Preemies: Study 3Health News:The fine line between breast cancer and normal tissues 2Health News:Download HeartBeat Experts White Paper: Stakeholder Management for new Prostate Cancer Products 2
... in need of blood or are you inclined in donating the ... way, the solution for it is just a few clicks away. ... amazingly useful venture in 2000. He works for Central Railway as ... venture too. ,If you're located in Kolkata and badly ...
... University immunologist and author of the study said that they have ... aim of the cure is to prevent the immune system before ... a window of time and the pancreatic cells can be rescued ... the disease. , The results were published in the ...
... of a suspected bird flu infection. After this incident ... shipments from out of town. ,The city ... for a final diagnosis of the case. Health authorities ... Her condition deteriorated quickly, and she died despite hospital ...
... the March of Dimes has shown that U.S pregnancy ... of 40 weeks//, which is a week shorter than ... the pregnancy term period is attributed to better capabilities ... assisted deliveries. As a result there are fewer stillbirths, ...
... Medical Center have found that teenagers who have used herbal ... and 15 times more likely to have // abused anabolic ... ,"The study points to the need for ... using herbal remedies and from there probe deeper for possible ...
... in China has revealed that just over 67 per cent ... ,This survey was conducted recently by a research institute at ... respondents in 24 colleges of 19 cities.,The results said that ... how HIV/AIDS is transmitted and 75.6 per cent know how ...
Cached Medicine News:Health News:New Network To Ease Blood donation In India 2Health News:Type 1 diabetes has a cure? 2Health News:Using Herbal Products Heightens Substance Abuse Risk in Teens 2
(Date:9/22/2014)... DUBLIN , Sept. 22, 2014 ... the "PCSK9 and Other Novel Hypercholesterolemia Drugs" ... indicate that there is a high cholesterol burden despite ... Out of all the available options, statins have been ... concluded that reduction of plasma LDL cholesterol (LDLC) is ...
(Date:9/22/2014)... 2014  Aethlon Medical, Inc. (OTCQB: AEMD), the ... infectious disease, cancer and other life-threatening conditions, disclosed ... (DARPA) has informed the Company that it plans ... four of a five-year $5.9 million contract that ... under DARPA,s Dialysis-Like Therapeutics (DLT) program. ...
(Date:9/22/2014)... , Sept. 22, 2014 /PRNewswire/-- CANTEL MEDICAL CORP. (NYSE: ... and fiscal 2014 ended July 31, 2014 on Monday, September ... to discuss the results at 11:00 AM ET. Participating in ... Andrew A. Krakauer , President and CEO; Jorgen ... A. Sheldon , Senior Vice President, CFO and Treasurer; and ...
Breaking Medicine Technology:PCSK9 and Other Novel Hypercholesterolemia Drugs 2PCSK9 and Other Novel Hypercholesterolemia Drugs 3Aethlon Medical Receives Notice of DARPA Contract Renewal 2Aethlon Medical Receives Notice of DARPA Contract Renewal 3Aethlon Medical Receives Notice of DARPA Contract Renewal 4Cantel Medical Corp. To Hold Conference Call To Discuss Results For Its Fourth Quarter And Fiscal 2014 Ended July 31, 2014 2
... N.J., Oct. 15 Watson Pharmaceuticals, Inc. (NYSE: ... Laboratories, Inc., has received approval from the United States ... Application (ANDA) for Amlodipine Besylate/Benazepril 5/20mg, 10/20mg, 2.5/10mg, and ... The ANDA was acquired as part of Watson,s acquisition ...
... Inc. (Nasdaq: REGN ) will webcast its ... Industry Conference on Friday, October 22, 2010.  The presentation ... may be accessed through the Company,s web site, ... version of the presentation will be available after the ...
Cached Medicine Technology:Watson's Generic Version of Lotrel ® Receives FDA Approval 2
... new thinking to address common problems associated ... mm diameter outer arthroscope sheath, the shorter, ... Videoscope has superior access and mobility in ... and especially in the elbow and ankle. ...
... is the second generation of the lens ... technology allows one-handed delivery of the C11UB ... colored plunger allows better visualization and is ... insertion. The modified 55-degree beveled tip eases ...
... Heart 2006 is a long-term Transtelephonic ... This device is the solution ... symptoms and their correlation to the ... it provides 2 lead loop recording ...
... cable and 4 metal chest electrodes ... 3-step procedure enabling a patient to ... lead ECG through a simple change ... seconds per lead and 10 seconds ...
Medicine Products: