July 6th, 2010 | 
Author: DBV Technologies (DBV), a biotech social meeting specializing in pabulum allergy with innovative products for diagnosis and treatment, announced the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application. DBV Technologies will begin clinical research of its have the lead of nourishment allergy desensitization candidate, VIASKIN® PEANUT, as being the desensitization to peanut allergy. The Company expects to set in operation recruitment of peanut allergy patients at several medical centers in the U.S. this month.
The objectives of the clinical study are to demonstrate DBV Technologies’ EPicutaneous ImmunoTherapy (EPIT) using VIASKIN® PEANUT is safe and well tolerated in both adult and pediatric peanut allergy patients, and to determine any appropriate dosing regimen for further efficacy trials.
DBV Technologies’ VIASKIN® aims to desensitize food allergy patients in close custody while minimizing hazard of systemic reactions. VIASKIN® Peanut is applied adhering independently of a fracture pelt and is completely non-invasive. VIASKIN® Peanut ensures adequate amounts of the allergen are delivered effectively to the immune competent cells in the epidermis.
DBV Technologies CEO and Co-Founder, Pierre-Henri Benhamou,MD, commented: “To date, there are not at all existing desensitization treatments for food allergies in the same state as peanut allergy forward the market. Peanut allergy is a origin of major anxiety for patients and families, especially in the U.S. where some estimated in greater numbers than two the public people permit from the allergy. The significant unmet medicinal emergency in the place of safe and powerful treatments of sustenance allergies is in every instance well recognized, especially as in the case of life menacing peanut allergies. The commencement of this clinical trial in the U.S. is a greater step forward in realizing our goal of providing patients suffering peanut allergies through an innovative, painless, safe and effective peanut desensitization manipulation. VIASKIN® Peanut is the in the first place desensitization product developed by means of DBV Technologies. We have additional desensitization VIASKIN® products for other food allergens in progression in a continuously ascending gradation.”
About DBV Technologies’ Peanut Allergy EPIT programme
Through its peanut specific EPIT order of exercise, DBV Technologies aims to safely desensitise patients suffering from peanut allergy by increasing the level of peanut proteins consumed symptom-free. The U.S. Medical Centres where submissive recruitment of the first clinical trial will begin are: Duke University Medical Center, Durham, NC; The National Jewish Medical & Research Center, Denver, CO; Arkansas Children’s Hospital Research Institute, Little Rock, AR, Aspen CR, Orem, UT; and CRI Worldwide, Willingboro, NJ.
According to the American Academy of Allergy Asthma & Immunology statistics, peanut allergy is one of the most predominant rations allergies in the U.S. by over 2 the public people poverty from this allergy. In the U.S. alone, sustenance allergies are responsible towards about 100,000 emergency compass visits and 150-200 deaths through year, fatal cheer anaphylaxis being greatest part often caused by means of peanuts. Due to the potentially fatal consequences of peanut allergy, this class represents a major health weight worldwide and imposes afflictive social and quality of life restrictions on afflicted individuals.
DBV Technologies has already published strong pre-clinical data supporting its peanut allergy EPIT programme. These are available in the place of write a critical notice of on the Scientific Publications serving-boy upon the body the DBV Technologies website. To date, no food allergy desensitisation treatments are currently marketed for the treatment of food allergies similar as peanut allergy.
About VIASKIN®
DBV Technologies’ patented VIASKIN® technology is a unique handing over system which retains agile compounds on a carrier using electrostatic forces only. The handing over platform allows active compounds to be presented to the cuticle of the skin without breaking the blood-skin barrier. In not breaking the blood-skin barrier, DBV Technologies’ allergen diagnosis and Epicutaneous Specific Immunotherapy (EPIT) should avoid inducing systemic shock – one of the most serious concerns associated with current desensitisation therapies.
Source:
DBV Technologies
Posted in Allergy Treatments