ASIT biotech is delighted to announce that it has received the green light from the Paul-Ehrlich Institute (Germany) to start a phase IIb clinical trial in grass pollen rhinitis with gp-ASIT+TM.
The company has completed a Phase IIa clinical trial with 61 subjects suffering from grass pollen allergy being treated during 5 weeks with the subcutaneously administered gp-ASIT+TM immunotherapy product.
The results of this clinical trial confirm that gp-ASIT+TM treatment
- is well tolerated and not dangerous at all;
- has a significant positive impact on the immune system by inducing antibodies that naturally block the allergic reaction (p<0.0001);
- reduces significantly (p<0.0001) the allergic response to an ocular challenge test with grass pollen allergens.
This ocular test is globally accepted by the regulatory authorities as a marker for predicting future efficacy of an immunotherapy product in field conditions. So, the proof of concept of gpASIT+TM efficacy in the desensitization of hay fever patients is obtained.
On the basis of these very positive results, ASIT biotech has filed the clinical documentation and get the approval to perform a Phase IIb clinical study to investigate the dose-response relationship for clinical efficacy of gp-ASIT+TM subcutaneously administered to hay fever patients.
This Phase IIb clinical study will be performed in Germany 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. The results of this trial will be available by the end of 2014.
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 Phase III 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. 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.