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:11/26/2014)... Texas , Nov. 26, 2014 ... today announced the completion of previously announced concurrent ... million.  After fees and estimated offering expenses, Lexicon ... the transactions.  The transactions consisted of: ... common stock, pursuant to a registration statement that ...
(Date:11/26/2014)... CUMBERLAND, Md. , Nov. 26, 2014  Over ... half of those suffer from this pain daily. Chronic ... specialty of pain management is born to fulfill the ... treat all types of pain. On October ... to the Cumberland, Maryland community.  ...
(Date:11/26/2014)... ELMSFORD, N.Y. , Nov. 26, 2014  BioScrip ® , ... M. Smith , President and Chief Executive Officer, will present at ... follows: , , , Date: , , , ... , , 2:50 p.m. EST , , , , Location: ... About BioScrip, Inc. ...
Breaking Medicine Technology:Lexicon Announces Completion Of $280 Million In Financing Transactions 2Lexicon Announces Completion Of $280 Million In Financing Transactions 3New Pain Management Center Opens in Cumberland, Md. 2
... LAKES, N.J., Dec. 29 BD (Becton, Dickinson and Company) (NYSE: ... would present at the following investor healthcare conferences in January: , , ... 6, 2010, 9:15 a.m. ET, 28th ... 6:30 p.m. ET, , A live webcast of BD,s ...
... PALM CITY, Fla., Dec. 29 Connectyx Technologies Holdings Group, ... a National RV Owners Community as a marketing partner to ... over one million members and more than 3,400 individual club ... The RV Club provides its membership with essential services ranging ...
Cached Medicine Technology:BD to Present at Investor Healthcare Conferences 2Connectyx Announces MedFlash Sales Partnership with National Recreational Vehicle Club 2Connectyx Announces MedFlash Sales Partnership with National Recreational Vehicle Club 3
(Date:11/28/2014)... 2014 Secura Consultants, based in ... marketing organizations in the country focused on delivering ... marketplace. Secura Consultants is proud to offer complimentary ... Group, a leading global financial company. , Many ... the ownership interest comes the need for business ...
(Date:11/28/2014)... Alex Kramer HealthDay ... Getting kids involved in the kitchen, through cooking classes or ... foods, according to a recent review. Cooking programs and ... and behaviors, according to the new research. And, although the ... findings suggest that such programs might help children develop long-lasting ...
(Date:11/28/2014)... CA (PRWEB) November 28, 2014 ... online, reported during the hugely popular, 2014 MTV ... antismoking organization Truth launched ground-breaking celebrity centered television ... The MTV viewership figures were estimated by ... antismoking ads placed the spotlight on celebrities photographed ...
(Date:11/28/2014)... UniWigs.com, a leader in the wig industry, has announced ... next Monday. This promotion features: , > 400 ... to 70% off (no coupon code needed), > ... on orders over $49 , Visit http://www.uniwigs.com for more ... 28th to Dec. 1st and the first 100 shoppers each day ...
(Date:11/28/2014)... An inventor from Flint, Mich., wants to minimize the trouble ... while lying in a hospital bed, unable to get up ... Buddy provides a more ergonomic and convenient way for a ... need to leave the bed, which avoids hassle and strain, ... and producible in design variations, it's ideal for elderly and/or ...
Breaking Medicine News(10 mins):Health News:Secura Consultants Offers Complimentary Buy-Sell Agreement Reviews 2Health News:Want Kids to Eat Better? Get Them Cooking 2Health News:Want Kids to Eat Better? Get Them Cooking 3Health News:Freedom Laser Therapy Applauds American Legacy’s Creative Advertising Targeting Celebrity Smokers 2Health News:Freedom Laser Therapy Applauds American Legacy’s Creative Advertising Targeting Celebrity Smokers 3Health News:Freedom Laser Therapy Applauds American Legacy’s Creative Advertising Targeting Celebrity Smokers 4Health News:Freedom Laser Therapy Applauds American Legacy’s Creative Advertising Targeting Celebrity Smokers 5Health News:Pre-X'mas Crazy Sale Starts from $0 at UniWigs.com 2
... today announced the,expansion of its proprietary pipeline, with ... orally-available small molecule compound,targeted for the treatment of ... inhibit major signalling pathways,involving Flt3 and CDK, which ... the most frequent genetic alterations,reported in acute myeloid ...
... NEWTOWN SQUARE, Pa., Nov. 27 In its ... homeopathy, Boiron,Laboratories disputes an editorial comment published in ... that its author has misinterpreted results of,clinical trials ... journal features an editorial by Ben Goldacre on,the ...
... say current labeling doesn,t reflect reports of bizarre behaviors ... (HealthDay News) -- A U.S. Food and Drug Administration ... Tamiflu (oseltamivir) should have a stronger warning label to ... who use the medication. , The FDA,s Pediatric Advisory ...
... ZMH ; SWX: ZMH) today announced that J. ... a member of the Board of Directors effective,November 30, ... John L.,McGoldrick, a current Board member, will serve as ... and Chief Executive Officer,of the Company from August 2001 ...
... Pronounced "mursa,",methicillin-resistant staphylococcus aureus (MRSA) is one of the ... it. It has,killed the elderly, babies, toddlers, teenagers and ... public schools., One of the most common places ... can start innocently, perhaps with a nick or cut. ...
... Rate..., CLEARWATER, Fla., Nov. 27 minSURG Corporation, ... it has certified over 600 surgeons in its TruFUSE ... in the basic technique at the,North American Spine Society ... believe that this milestone is a reasonable predictor that ...
Cached Medicine News:Health News:S*BIO Expands Pipeline With the Development of a Unique Flt3 -CDK Inhibitor as a Targeted Therapy for Acute Leukemias 2Health News:Boiron Laboratories Disputes British Journal's Editorial on Homeopathy 2Health News:Boiron Laboratories Disputes British Journal's Editorial on Homeopathy 3Health News:FDA Panel Backs Tougher Warning for Tamiflu 2Health News:FDA Panel Backs Tougher Warning for Tamiflu 3Health News:Ray Elliott to Retire as Chairman of Zimmer Holdings; John McGoldrick to Serve as Non-Executive Chairman 2Health News:Ray Elliott to Retire as Chairman of Zimmer Holdings; John McGoldrick to Serve as Non-Executive Chairman 3Health News:New Booklet Reveals 12 Proven Methods for Stopping MRSA from Infecting Your Feet and Your Family's Feet 2Health News:Over 600 Surgeons Certified to use TruFUSE(R) to Treat Back Pain Sufferers 2
PremierEdge™ Stab Knives - 15°....
Interchangeable design allows you to select a single handpiece and change tips during the procedure. Universal connector. Disassembles for easy cleaning. Tips can rotate 360 degrees to re-orient port...
Interchangeable design allows you to select a single handpiece and change tips during the procedure. Universal connector. Disassembles for easy cleaning. Tips can rotate 360 degrees to re-orient port...
Infusion Cannula, 2.0mm....
Medicine Products: