The safety of low doses of gpASIT+TMadministered by subcutaneous injections in grass pollen allergic patients has been confirmed in BTT-gpASIT004 and BTT-gpASIT006 clinical studies performed in collaboration with Prof.Dr. med Jan Ceuppens of the Department of Allergy and Clinical Immunology of the UZ Leuven.
Complementary analyses by Dr M. Shamji (Imperial College, London) of the results of these two clinical studies demonstrate that a short 5-injection regimen is sufficient to modulate immune responses in a manner similar to current therapies, which typically require a minimum of 2 years treatment to induce clinical tolerance.
The follow-up of the patients enrolled in BTT-gpASIT006 study also confirmsthat the modulation of the immune responseslasts for at least 1 year after treatment.
A protocol extension has been submitted to the competent authorities in order to assess effects at 2 years of a 5-injection treatment with gpASIT+TM.
This week, the ethical committee of the University of Leuven has approved the study protocol.
BTT expects the results to be available by the end of Q1 2014.
About BioTech 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.
ASIT+TM products are based on highly purified allergen fragments obtained from natural sources. 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. Moreover, purification of the antigen fragments removes pro-inflammatory mediators which favor side-effect. The use of natural sources of allergens results in a product which includes a very broad panel of epitopes which cover all the allergens present in the current immunotherapy products.