Navigation Links
Ception Therapeutics Initiates Phase II/III Clinical Trial for Its Lead Product Reslizumab in Eosinophilic Esophagitis (EE) in Children
Date:3/5/2008

FDA Also Grants Orphan Drug Status to Reslizumab for Pediatric EE

MALVERN, Pa., March 5 /PRNewswire/ -- Ception Therapeutics, Inc. announced today the initiation of a multi-center, Phase II/III clinical trial to evaluate reslizumab, a humanized monoclonal antibody (mAb) against interleukin-5 (IL-5), for the treatment of eosinophilic esophagitis (EE) in pediatric patients. EE is a chronic inflammatory disease characterized by difficulty swallowing, vomiting, stomach or chest pain, and a failure to thrive. IL-5 is the major cytokine responsible for the eosinophilic inflammation of the esophagus seen in this condition.

The U.S. Food and Drug Administration (FDA) has granted orphan drug status to reslizumab for the treatment of pediatric EE. This designation is part of a well-established program designed to support the development of drugs for rare diseases which affect fewer than 200,000 people in the United States. Depending upon the study results, Ception expects to file a Biological License Application (BLA) with the FDA for reslizumab based on this study.

"The initiation of this study marks a major corporate milestone for Ception," said Steve Tullman, co-founder, President and CEO of Ception Therapeutics, Inc. "Over the last decade, awareness of EE has dramatically increased, but currently, there is no approved treatment. Children with this disease may suffer significant morbidity and it can be a challenge for them to maintain proper nutrition."

The study (Res-05-0002) is a randomized, double-blind trial of reslizumab versus placebo in the treatment of pediatric patients between 5 and 18 years of age with poorly-controlled EE. Subjects will be randomized to one of three active dose groups or placebo, administered at monthly intervals for four months. The co-primary endpoints of the study are changes in clinical symptoms and esophageal eosinophil levels at the end of therapy. The clinical study is being conducted at multiple cente
'/>"/>

SOURCE Ception Therapeutics, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Huge Drop in Preterm Birth-Risk Among Women Taking Folic Acid One Year Before Conception
2. A Sociolinguistic Analysis of In-Office Dialogue Reveals Psychiatrists and Parents Have Significantly Different Perceptions on ADHD and Psychiatric Comorbidities
3. Cell Therapeutics, Inc. (CTI) Submits European Marketing Authorization Application for XYOTAX(TM)
4. InteKrin Therapeutics Announces Initiation of Phase 2b Study in Type 2 Diabetes with INT131
5. Oncology Drug Development Update - Molecular Profiling Redefines the Nature of Malignancy and Increases the Adoption of Targeted Therapeutics
6. TorreyPines Therapeutics Announces Strategic Plan with Focus on Clinical Development Activities to Maximize Value of Versatile Lead Compounds
7. Horizon Therapeutics Completes Enrollment in Phase 3 Trials for Lead Product Candidate HZT-501
8. Multiple Dose Clinical Trial of TorreyPines Therapeutics Tezampanel Demonstrates Compound is Safe and Well-Tolerated
9. PTC Therapeutics Announces Publication of Preclinical Data in PNAS
10. ImaRx Therapeutics Transitions Business Strategy
11. Protalix BioTherapeutics Extends Research Agreement With Yissum Based on Promising Acetylcholinesterase Program Results in Animal Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... , Dec. 24, 2014  The International Trade Commission (ITC) ... (RMD) against BMC Medical. In a notice issued on December ... that ResMed,s patent on its humidifier was invalid. ... "monumental win". "We are very excited with the ITC,s decision ... that we have taken since the very beginning on the ...
(Date:12/24/2014)... and LONDON , December ... orthopedic industry are expected to grow at an average ... terms of value and volume. Hip, knee and spine ... world while in emerging economies they have a lower ... are challenging the use of composites. Non-metallic orthopedic devices ...
(Date:12/24/2014)... ResMed (NYSE: RMD ) today announced ... medical device manufacturer BMC Medical Co., Ltd. ... listed below infringe ResMed,s patents, and entered an order prohibiting ... the United States : , iVolve ... Willow nasal pillows mask , iVolve full face mask ...
Breaking Medicine Technology:ITC Final Decision Goes Against ResMed (RMD) Monumental Win for 3B/BMC 2Use of Composites in Orthopedic Industry to Reach $596 Million by 2020 2Use of Composites in Orthopedic Industry to Reach $596 Million by 2020 3ResMed Wins Patent Infringement Lawsuit Against Chinese Manufacturer BMC Medical 2
(Date:12/26/2014)... (PRWEB) December 26, 2014 Cooking ... of 3.1 out of 5. This score reflects slightly ... level of product specialization, low switching costs and a ... reduced by the low availability of substitutes for cooking ... price of steel and aluminum, key inputs in the ...
(Date:12/26/2014)... December 26, 2014 “Many people become ... personal injury claim issues and phone calls with insurance ... an article featuring their free eBook on pedestrian ... eBook on pedestrian and bicycle auto accident claims assures ... fully capable of professionally handling their case while they ...
(Date:12/26/2014)... (PRWEB) December 26, 2014 Parker ... for the best in heating, cooling and plumbing ... 24 hour emergency services in 2014 with regard ... know that Arizona is known for its incredibly ... that understands the intricacies and details of a ...
(Date:12/25/2014)... The report “Nintedanib (Colorectal Cancer) ... on the current treatment landscape, unmet needs, current ... market. Stivarga is a drug which is used ... Boehringer Ingelheim is developing nintedanib (BIBF-1120), an orally ... CRC in the US, Europe, and Japan. The ...
(Date:12/25/2014)... 26, 2014 Recently, iFitDress.com, the popular online ... has announced its new selection of black one-shoulder cocktail ... sale now; they are available at discounted prices, up to ... promotion will last for three weeks only. You know, we ... who are interested in our new items can visit our ...
Breaking Medicine News(10 mins):Health News:Cooking & Warming Equipment Procurement Category Market Research Report from IBISWorld has Been Updated 2Health News:Cooking & Warming Equipment Procurement Category Market Research Report from IBISWorld has Been Updated 3Health News:Guide to Handling Pedestrian and Bicycle Accidents Released By The Jones Firm, Featured in Recent Article 2Health News:Parker & Sons Announces Record Demand For 24 Hour Emergency Services In 2014 With Regard To Air-Conditioning Systems 2Health News:Parker & Sons Announces Record Demand For 24 Hour Emergency Services In 2014 With Regard To Air-Conditioning Systems 3Health News:Nintedanib Colorectal Cancer Market Analysis and Forecast to 2023 Report at RnRMarketReserach.com 2Health News:Nintedanib Colorectal Cancer Market Analysis and Forecast to 2023 Report at RnRMarketReserach.com 3Health News:Nintedanib Colorectal Cancer Market Analysis and Forecast to 2023 Report at RnRMarketReserach.com 4Health News:iFitDress.com: Black One-Shoulder Cocktail Dresses for 2015 2
... report published in the January/February issue of General Dentistry, ... says that most children's medicines have the potential to ... in them. // ,For example, antihistamine syrups contain ... pH levels, which mean that they are high in ...
... alcohol dependence is greatly increased if an individual has a ... on the tongue // . The taste receptor gene, called ... at the Washington University School of Medicine have studied more ... of the family participated in a study called Collaborative Study ...
... very little precautionary measures can be taken to actually prevent ... infection in humans is actually caused by the H5N1 strain ... global pandemic it has issued various guidelines which will reduce ... The government says that as such there is no vaccine ...
... Australian Health Minister Tony Abbott told the press that all the ... they consulted qualified health care // personnels. ,This ... rural areas. But in a period of six months this plan ... ,This plan will help in reducing the amount of expenditure ...
... Museum in London has found a unique way to help people ... the much-needed dose of light // . ,The Dana ... dark winter days. ,Up to 500,000 people, a majority ... affective disorder. SAD is more common in the northern latitudes ...
... The worldwide scare of bird flu pandemic as increased which ... bird flu drug by many countries//. U.S. has stocked more ... producing the generic version of the drug Tamiflu manufactured by ... rush for shikimic acid which is used for production of ...
Cached Medicine News:Health News:Genetic Variation In Bitter-Taste Receptor Gene Increases Alcoholic Risk 2
... an effective upgrade path that allows users ... 200 modularity. The potential to combine two ... through a single stimulating coil. The ability ... independently the power level of each Magstim ...
... Model 200 uses a brief magnetic pulse ... World market leader in Magnetic Nerve Stimulators. ... University of Sheffield in 1985. A powerful ... peripheral stimulation. Our best stimulator for Central ...
... is a surgical approach to glaucoma management ... application. The ciliary body (which produces aqueous ... the anterior or posterior segment, through the ... are easily and accurately identified utilizing endoscopy. ...
... Endoscopic CycloPhotocoagulation (ECP) is a surgical ... endoscopy and visualized laser application. The ciliary ... by the surgeon, from the anterior or ... time. The target tissues are easily and ...
Medicine Products: