Following approvals from the Ethics Committee at the University Hospital of Dresden and from the German Regulatory Authorities (Paul Ehrlich Institut, PEI), BTT-gpASIT007 study was successfully launched in August 2013.
The primary objective of this study is to define the maximum tolerated dose of subcutaneously administered gpASIT+TM. Other objectives of BTT-gpASIT007 study are to confirm the positive impact of a short course treatment with gpASIT+TM on the immune system and a reduction of the allergic reaction measured by a validated Conjunctival Provocation Test (CPT) performed before and after treatment as a preliminary assessment of the clinical efficacy of gpASIT+TM.
Sixty grass pollen allergic patients were recruited in the study as planned. The treatment phase is now in progress. ASIT biotech expects the results to be available by the end of Q1 2014.
This study is being conducted in collaboration with Prof. Dr. med. Dipl.-Ing. Ralph Mösges from the Institute for Medical Statistics, Informatics, and Epidemiology at the University of Cologne, Dr. med. Bettina Hauswald from the Oto-Rhino-Laryngology University Clinic at the University of Dresden and with Dr Mohamed Shamji from the Department of Allergy & Clinical Immunology at Imperial College London.
About gp-ASIT+TM product
gp-ASIT+TM immunotherapy product is based on highly purified allergen fragments obtained from grass pollen. The use of allergen fragments reduces the risk of allergic reactions by approximately 100-fold; the very high degree of purity of the fragments results in a product with a superior safety profile.
First clinical trials performed with gp-ASIT+TM have shown that a short 5-injections regimen with these highly purified allergen fragments is able to modulate immune responses in grass pollen allergic patients. Dr M. Shamji from the Department of Allergy & Clinical Immunology at Imperial College London considers that gp-ASIT+TM may confer clinical benefit with higher safety profile and improve quality of life of patients with severe summer hay fever
About BioTtech Tools
BioTech Tools s.a. is a clinical stage biopharmaceutical company committed to the development and commercialization of novel immunotherapy medicines for respiratory and food allergies based on the ASIT+TM technology platform. Three products based on this platform are currently in development: gp-ASIT+TM for grass pollen rhinitis, hdm-ASIT+TM for house dust mite asthma and pnt-ASIT+TM for peanut allergy.