Drug Delivery System and Target-Associated Cytostatic Drug Formulation

The aim of the project is the development and testing of suitable methods for a safe application of intrathoracic chemoaerosol therapy in the preclinical model as well as the technical establishment for later clinical use. Here, the focus is on both a user-friendly, cost-conscious design and on staff safety during implementation.

Together with our cooperation partner, the Pharma Resources Ltd., the medical technology components for the application of intrathoracic chemoaerosol therapy are being developed and evaluated for subsequent clinical use. In addition, an optimal cytostatic drug formulation for intrathoracic chemoaerosol therapy is being evaluated to match the components. The coordination on the product development side lies with Pharma Resources GmbH.
The project is financed by the European Union through the Regional Development Fund (ERDF) and by the state of Lower Saxony.

Background:

The development project is generally based on the clinical fact that in progressive, primarily malignant diseases of the pleura such as mesothelioma, tumors growing into the pleura such as thymoma or secondary metastasis of an underlying malignant disease into the pleura, often no or hardly any satisfactory tumor control can be achieved by standard systemic chemotherapy or by surgical intervention: The malignant disease recurs early, shows no response or even progression under conventional chemotherapeutic therapy. Malignant mesothelioma of the pleura (pleura of the ribs, pleura of the lung) and advanced thymic carcinomas have an overall extremely poor prognosis in terms of cure and long-term survival rates. The spectrum of available therapeutic options is limited. One of the more novel treatment approaches for pleural mesothelioma, pleural carcinomatosis, and thymic carcinoma is the HITHOC procedure (Hypertherme Intra- ThOrakale Chemotherapy), which is accompanied by a surgical intervention: a previously extensive, macroscopic tumor removal under anesthesia is followed by the chemotherapeutic, microscopic destruction of any locally remaining tumor tissue under irrigation with a heated chemotherapy solution. Although this treatment concept is gaining increasing attention in thoracic surgery, the procedure is extremely complex from a technical and surgical point of view and is not suitable for every patient. In addition, this procedure uses very high amounts of cytostatic agents compared to the chemoaerosol therapy to be developed.