Brussels, August 9th 2013
BioTech Tools is delighted to announce that it received the green light from the Paul-Ehrlich Institute (Germany) to start a phase IIa clinical trial in grass pollen rhinitis with gp-ASIT+TM.
This Phase IIa dose-escalation study will investigate the safety, clinical tolerability and immunogenicity of increasing doses of gp-ASIT+TM administered subcutaneously to hay fever patients.
The primary objective of this clinical trial is to determine the maximum tolerated dose of our product gp-ASIT+TM.
This clinical trial will be performed in collaboration with Univ.-Prof. Dr. med. Dipl.-Ing. Ralph Mösges from the Institute for Medical Statistics, Informatics, and Epidemiology of the University of Cologne and with Dr. med. Bettina Hauswald from the Oto-Rhino-Laryngology University Clinic of the University of Dresden.
The results of this trial will be available by the end of 2013. These data taken together with existing data from previous studies will allow BioTech Tools to further develop the ASIT+TM products and contribute to the optimal design of the next phase clinical trials.
About the Paul-Ehrlich-Institut:
The Paul-Ehrlich-Institut (PEI), located in Langen, Hessen, is an institution of the Federal Republic of Germany. It is a senior federal authority reporting directly to the Federal Ministry of Health (Bundesministerium für Gesundheit, BMG). It is responsible for the research, assessment, and marketing authorisation of biomedicines for human use and veterinary vaccines. Its remit also includes the authorisation of clinical trials and pharmacovigilance, i.e. recording and evaluation of potential adverse effects. Other duties of the institute include official batch control, scientific advice, and inspections. In-house experimental research in the field of biomedicines and life science form an indispensable basis for the varied and many tasks performed at the institute.
The PEI, with its roughly 800 staff, also has advisory functions at a national level (Federal Government, German states) and an international level (World Health Organization, European Medicines Agency, European Commission, Council of Europe etc.).
About BioTech Tools:
BioTech Tools s.a. (BTT) 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.