Prostate Cancer Study in the US

With its potential to completely ablate small prostate tumors, there appears to be huge potential for NanoTherm® therapy as a monotherapy in early to intermediate prostate cancer patients with an opportunity to prolong active surveillance periods, support organ preservation, and enhance the quality of life.

The U.S. Food and Drug Administration (FDA) has granted our US subsidiary MagForce USA, Inc. the Investigational Device Exemption (IDE) to conduct a clinical trial with NanoTherm® therapy as focal ablation treatment for intermediate risk prostate cancer. The approval of this IDE now allows MagForce to conduct a pivotal clinical evaluation with our innovative therapy at selected medical centers in the US.

We believe that the registration clinical trial will prove that NanoTherm therapy can fulfill the desired outcome, and we are looking forward to working with the FDA teams and advancing the registration process in the USA. A success in the US could finally also be a trigger for a later breakthrough in Europe in this indication.

In order to conduct the study, we have already installed two NanoActivator® devices, magnetic field applicators in which the NanoTherm®  therapy is performed, at University of Washington Medical Center in Seattle and at CHRISTUS Santa Rosa Hospital - Medical Center in San Antonio.This NanoActivator® devices are similar in design to those operating in Germany applying NanoTherm® therapy for the treatment of Brain Tumors. However, the USA NanoActivator® devices have been modified to apply NanoTherm® therapy for the treatment of Prostate Cancer in addition to the treatment of Brain Tumors.

KEY PARAMETERS OF THE PROSTATE CANCER STUDY IN THE USA

The purpose of this focal thermal ablation registration study that will enroll up to 120 men in a single arm study is to demonstrate that NanoTherm® can focally ablate cancer lesions for patients who have progressed to intermediate risk Prostate Cancer stage and are under active surveillance. By focally ablating these cancer lesions, it is anticipated that patients will be able to be maintained in Active Surveillance Programs and to avoid definitive therapies such as surgery or whole gland radiation with their well-known side effects. Potentially 50,000 to 100,000 men in active surveillance programs in the US could benefit from this focal therapy after registration.

Prostate cancer

is the most commonly diagnosed cancer in men in the USA. According to the National Cancer Institute, around 238,590 new cases of cancer will be diagnosed and about 29,720 men will die of prostate cancer in the US in 2013. In the USA alone, over USD 10 billion are spent annually treating prostate cancer; hence the market is ten times larger than for glioblastoma Due to demographic changes and extensive screening, incidence cases are expected to grow significantly in the next ten to 20 years. With the use of PSA testing in the USA during the past decades, prostate cancer has been identified and treated earlier, leading to a sharp decline in prostate cancer that has metastasized outside of the prostate gland. At the time of diagnosis, most men (four out of five) are reported to have localized prostate cancer and, as it is growing slowly, nearly 100% of all men diagnosed with localized prostate cancer live at least five years after diagnosis. There appears to be a major opportunity to develop a valued focal therapy that can be utilized to control the slow growing cancer, and keep it non-aggressive, prevent metastasis during the life of the patients, or become a valuable adjunct to radiations for high-risk and recurrent prostate cancer.