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VALIDATION OF THE BIOTECHNOLOGICAL PROCESS AND PRODUCTION OF A FIRST LOT OF SAMPLES FOR CLINICAL TRIALS

Objective

Thromboembolic diseases in general and myocardial infarction in particular are a major cause of mortality and morbidity world-wide. In Germany alone, more than 300,000 patients annually suffer from myocardial infarction and 40%have to undergo thrombolytic therapy. However thrombolytic therapy with plasminogen activators has led to a significant improvement in the outcome of these life-threatening diseases. Nevertheless, all drugs available to date have a limited efficacy and cause systemic side effects on the hemostatic system. In addition, the most advanced thrombolytic (rt-PA) is available only at a very high price which has limited its application.

The project contributed to the ongoing development of an existing biotechnological process.

The production of recombinant straphylokinase, which had been shown to hold very high promise for an improved treatment of myocarial infaction and other thromboembolic diseases. The estimated worldwide market size for thrombolytic drugs is approx US $1.5 billion. The process was originally developed by the Hans-Knöll-Institut für Naturstofforschung (HKI), Jena, the Center for Molecular and Vascular Biology (CMVB), Leuven, Medac, Hamburg and Thromb-X, Leuven. The work was based on a pilot clinical trial, which compared the efficacy of staphylokinase against the best available current treatment in 100 patients with myocardial infarction.

The two main activities of the project were:
- validation of the biotechnological process for the production of recombinant straphylokinases in order to obtain a product quality which meets European regulations and which would be suitable for human consumption
- production of recombinant straphylokinase samples of sufficiently high quality and purity for stability, toxicological and initial formal testing i.e. developing a GMP environment

Technology transfer can be seen in the development of Straphylokinase, as the initial research took place using a biotechnological procedure in an academic sphere. Academics foresaw the advantages of the function properties of Straphylokinase but neither of the partners could take it forward to commercialise themselves. Therefore funding was sought from the EU innovation programme.

Funding Scheme

CSC - Cost-sharing contracts

Coordinator

MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH
Address
Fehlandtstrasse 3
20354 Hamburg
Germany

Participants (3)

HANS-KNÖLL-INSTITUT FÜR NATURSTOFFORSCHUNG E.V.
Germany
KATHOLIEKE UNIVERSITEIT LEUVEN
Belgium
THROMB-X NV
Belgium
Address
Herestraat 49