DRUG DELIVERY SYSTEM AND TARGET-ASSOCIATED CYTOSTATIC FORMULATION

Dr. Patrick Zardo

Development of an innovative drug delivery system and a target-associated cytostatic formulation for the clinical establishment of intrathoracic chemoaerosol therapy as a new treatment method for thorax-associated malignancies

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

Together with our cooperation partner, Pharma Resources GmbH, the medical technology components for the application of intrathoracic chemoaerosol therapy are being developed and evaluated for later clinical use. In addition, an optimal cytostatic formulation for intrathoracic chemoaerosol therapy is being evaluated to match the components. Pharma Resources GmbH is coordinating the product development side of the project.

The project is funded by the European Union via 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 a malignant underlying disease into the pleura, often no or hardly satisfactory tumor control can be achieved by standard systemic chemotherapy or 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 and lungs) and advanced thymus carcinomas have an extremely poor prognosis in terms of cure and long-term survival rates, and the range 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(HyperthermicIntra-ThOracal Chemotherapy), which involves a surgical procedure: a previously extensive, macroscopic tumor removal under anesthesia is followed by the chemotherapeutic, microscopic destruction of any remaining local tumor tissue under irrigation with a heated chemotherapy solution. Although this treatment concept is gaining more and more 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, the amount of cytostatic drugs used in this procedure is comparatively higher than would be the case with the chemoaerosol therapy to be developed.