Bitop AG Announces Start of Clinical Trial with Ectoin Inhalation Solution in Patients with Inflammation and Obstruction of the Airways
The present clinical study is a single-center efficacy and feasibility study involving patients with inflammation and airway obstruction in Germany. After the successful feasibility a long term study extension will investigate the effect of Ectoin Inhalation Solution of lung function decline, lung ageing and inflammation. bitop makes use of Pari Pharma's eFlow nebulisation technology to obtain optimal delivery of the Ectoin Inhalation Solution into the lungs.
"Environmental pollution of the lungs poses a growing problem for the inhabitants of industrialised countries, leading to diseases like COPD with a high economic burden. The local application of cell-protection molecules like Ectoin opens up new options for treatment in this field"states Prof. Ursula Kraemer at the Leibniz-Institut für Umweltmedizinische Forschung.
Recent clinical studies with Ectoin-containing medical devices show excellent results in efficacy and safety in the treatment of allergic rhinitis and conjunctivitis or atopic dermatitis.
Ectoin Inhalation Solution has already shown marked therapeutic efficacy in the treatment of mild asthma in humans and in animal models of nanoparticle-induced inflammatory reaction in the lungs, allergen induced asthma.
"Ectoin-containing medical devices have already shown very positive effects in different diseases. We hope that we can show in this study that Ectoin Inhalation Solution can be used to protect individuals against unavoidable environmental nanoparticle-induced inflammatory reaction in the lung" says Dr. Andreas Bilstein, Head of Medical Device Development at bitop AG.
Further information on the study is also available on http://www.clinicaltrials.gov/.
The extremolyte Ectoin (2-Methyl-1,4,5,6-tetrahydropyrimidine-4-carboxylic acid) is a cyclic amino acid that is produced mainly by halophilic bacteria to protect the cells from the extreme osmotic stress associated with saline conditions. Ectoin protects biological macromolecules and structures from adverse environmental conditions, minimizes the denaturation of biopolymers occurring under water stress conditions, and stabilizes proteins by maintaining the protein hydration structure.
The mode of action of Ectoin Inhalation Solution is associated with the water retaining capability of Ectoin and the formation of a protective hydro complex on the lung epithelium which shields the cells against stress. Furthermore, Ectoin is able to protect human tissue cells by interfering with signaling pathways that are initiated at the level of the cell membrane. Ectoin is water-soluble, chemically stable, non-toxic and highly compatible with cell metabolism. bitop AG develops Ectoin for the co-treatment of inflammatory diseases in different indications.
About bitop - www.bitop.de
bitop AG, located in Witten, Germany, develops and markets Ectoin-containing medical devices for different therapeutic areas such as asthma, COPD, allergy, and dermatology. Inhalative medical devices containing Ectoin are currently developed and are an opportunity for health care companies seeking a partnership for the indications asthma and COPD. Ectoin-containing products for the local treatments of allergies or atopic dermatitis have proven efficacy and are open for out-licensing.
Ectoin-containing products are already successfully marketed internationally in the dermatologic area for anti-aging, skincare, and sun protection.
About IUF - www.iuf.uni-duesseldorf.de
The IUF (Institut für umweltmedizinische Forschung or Environmental Health Research Institute) was founded in 2001 as a non-profit, limited liability company. Scientific director of the institute is Jean Krutmann, M.D., Professor of Environmental Health Research and Dermatology. The IUF is institutionally supported by the Federal State of North Rhine-Westphalia. It has about 100 employees of whom 60 are financed through external project-related grants provided by the Federal Ministry of the Environment, the Deutsche Forschungsgemeinschaft (DFG), the European Union and other research-funding institutions.The IUF's major task is to carry out molecular preventive medical research in the area of environmental health. The main objective is the analysis and evaluation of risks to human health that result from environmental factors in order to improve health care and to develop more preventive and therapeutic strategies.
About PARI Pharma and eFlow® Technology - www.paripharma.com
PARI Pharma is a world leader in the development of aerosol delivery devices and inhalation drug products using its proprietary technologies and expertise. PARI's platform of nebulizer systems based on eFlow Technology incorporate a vibrating, perforated membrane in either a portable, handheld device or specialized devices for use in ventilator or CPAP breathing assist applications. eFlow Technology products are designed to significantly improve lung deposition and reduce the burden of treatment for patients with severe respiratory conditions.