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Ception Therapeutics Initiates Phase II/III Clinical Trial For Its Lead Product Reslizumab In Eosinophilic Esophagitis (EE) In Children
Ception Therapeutics, Inc.
announced 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 centers and will
enroll approximately 172 patients. For more information on this clinical
trial, please visit http://www.clinicaltrials.gov [Identifier:
NCT00538434].
About Reslizumab
Reslizumab is a humanized mAb against IL-5. IL-5 plays a crucial role
in the maturation, growth and chemotaxis of eosinophils, inflammatory cells
implicated in a number of allergic diseases.
About Eosinophilic Esophagitis
Eosinophilic esophagitis (EE) is a disease that has become increasingly
recognized in children and adults over the last decade.(1) It is
characterized by an accumulation of eosinophils in the esophagus in
association with symptoms that frequently mimic gastro-esophageal reflux
disease (GERD).(2) Specifically, patients typically report symptoms that
include difficulty feeding and failure to thrive in younger children, as
well as vomiting, epigastric or chest pain, dysphagia, and food
impaction.(2) The diagnosis must be made on the basis of an esophageal
biopsy demonstrating the presence of significant numbers of eosinophils,
clinical symptoms, and the absence of acid reflux or failure to respond to
acid reduction therapy.(1)
Allergic responses have been strongly implicated in the etiology of
EE.(1) The overexpression of the cytokine IL-5 by T helper type 2 cells is
thought to play a major role in the pathogenesis of the disease.(1)
Therapies currently utilized for EE include severely restricted diets,
including an elemental formula diet typically administered by nasogastric
or gastrostomy tube.(2) There are no approved pharmacologic therapies for
EE, although corticosteroids are sometimes administered to patients.
About Ception Therapeutics, Inc.
Ception Therapeutics is a biopharmaceutical company focused on the
discovery and development of novel products to address areas of unmet
medical need. The Company's pipeline includes reslizumab in clinical
development for eosinophilic inflammatory conditions and an orally
available small molecule anti-TNF program. Ception Therapeutics pursues new
drug targets through a proprietary thermodynamics-based rational drug
design platform. For further information, visit http://www.ceptiontx.com.
(1) Furuta, G., Liacouras, C., et al. Eosinophilic Esophagitis in
Children and Adults: A Systemic Review and Consensus Recommendations
for Diagnosis and Treatment. Gastroentergology 2007:133:1342-1363
(2) Blanchard, C., Wang, N., Rothenberg, M. Eosinophilic esophagitis:
Pathogenesis, genetics, and therapy. J. Allergy Clin Immun. November
2006 (Vol. 118, Issue 5, Pages 1054-1059)
Ception Therapeutics, Inc.
http://www.ceptiontx.com
Ception therapeutics iniþiazã de fazã II / III, studiu clinic pentru produsul sãu duce Reslizumab în eozinofile Esophagitis (EE) la copii - Ception Therapeutics Initiates Phase II/III Clinical Trial For Its Lead Product Reslizumab In Eosinophilic Esophagitis (EE) In Children - articole medicale engleza - startsanatate