NanoTherm® Therapy - A new approach to local treatment of tumors

We have set up this page of our website specifically for you, the patient, so that you can find answers to frequently asked questions about NanoTherm® therapy. Our aim is to explain briefly, but in detail, how treatment with NanoTherm® therapy works and how you can take part in our ongoing
studies.

HOW DOES NANOTHERM® THERAPY WORK?

NanoTherm® therapy is a new procedure for the local treatment of tumors.
The principle of this method is direct, minimally invasive instillation of
magnetic nanoparticles (NanoTherm® particles) into a tumor and their subsequent heating using an alternating magnetic field. This produces heat locally from inside the tumor, sparing surrounding healthy tissue.

NanoTherm® particles are very small particles suspended in water with an
iron oxide core and an aminosilane coating. They are approximately 15
nanometers (= 5 millionths of a millimeter) in diameter. Because of the
aminosilane coating, the nanoparticles stay in the place where they were
injected. Once the NanoTherm® particles have been introduced into the
tumor, specially developed NanoPlan® software is used to generate a
computer simulation of expected temperatures in the tumor and in the
surrounding healthy tissue. According to the selected strength of the
magnetic field, the attending physician can adjust the temperatures in order
to heat the entire tumor if possible and either damage the tumor cells irreparably or sensitize them to concomitant radiotherapy or chemotherapy,
while at the same time sparing healthy tissue by ensuring that it is not heated
above 43°C.

Treatment in the alternating magnetic field applicator, the NanoActivator™, is administered six times, twice a week over a three-week period. During the first treatment, the temperature in the treatment area is measured with a temperature probe that is pushed into a catheter that was inserted into the tumor during the NanoTherm® instillation. This makes it possible to adjust the strength of the magnetic field, and thus the temperatures reached, while treatment is in process. The settings determined in this way are retained for further treatments and the temperature measurement catheter is removed.
The NanoTherm® particles remain in place in the treatment area, thereby enabling repeat treatments in the alternating magnetic field and integration into multimodal therapy concepts.

WHICH TYPES OF TUMORs ARE TREATED IN THE CLINICAL STUDIES?

The admission of patients to the clinical studies on prostate and pancreas carcinomas is now complete. A further study on glioblastoma is currently in preparation. That is a post-marketing study after licensing the therapy. We expect to begin admitting patients to the glioblastoma study beginning in 2013. Studies for other indications are planned.

WHAT COSTS ARE INCURRED BY PARTICIPATING IN A STUDY?

Patients incur no costs by participating in a study.

WHERE DOES TREATMENT TAKE PLACE?

Instillation of the NanoTherm® particles takes place at the hospitals participating in the glioblastoma study. These include the Charité Universitätsmedizin in Berlin and the university hospitals in Düsseldorf, Frankfurt, Giessen, Kiel, Cologne and Münster. Others are planned.
Alternating magnetic field treatments take place in hospitals where a NanoActivator™ has been installed. At present only one NanoActivator™ is available and ready for use, in the Charité Universitätsmedizin Department of Radiotherapy on the Virchow-Klinikum campus in Berlin. Others will follow by the time the glioblastoma study begins.

Our clinical team will be happy to assist with any questions. However, please consult your attending physician before deciding whether to take part in a clinical study.