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MagForce enrols first patient in NanoTherm Therapy study
Berlin, Germany & Nevada, USA - Tuesday, July 3, 2018, 10:00 Hrs  [IST]
MagForce AG, a leading medical device company in the field of nanomedicine focused on oncology, together with its subsidiary MagForce USA, Inc. has announced MagForce USA has enrolled the first patient in its pivotal clinical evaluation with the company’s innovative NanoTherm selective ablation.

Following the Investigational Device Exemption (IDE) approval by the US Food and Drug Administration (FDA) announced earlier this year, recruitment in the trial is underway at the two trial sites, the CHRISTUS Santa Rosa Hospital - Medical Center and the University of Washington.

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 therapy can focally ablate cancer lesions with minimal side effects 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.

NanoTherm therapy represents a new concept for interstitial hyperthermia of the prostate. This method is based on the controlled transfer of energy from an alternating magnetic field to biocompatible, superparamagnetic nanoparticles injected into the tumor. The resulting amount of heat generated is suitable to directly destroy cancer cells.

The study will be conducted at medical centers in the US, where NanoActivator devices have been installed: at the University of Washington in Seattle, and the CHRISTUS Santa Rosa Hospital - Medical Center in San Antonio, Texas. Dr. Ian M. Thompson, Jr., President of CHRISTUS Santa Rosa Hospital - Medical Center and Director Cancer Therapy and Research Center, a National Cancer Institute-designated Cancer Center at the University of Texas Health Science Center at San Antonio, and Dr. Dan W. Lin, Chief of Urologic Oncology and Professor in the Department of Urology at the University of Washington School of Medicine in Seattle, have agreed to be co-principal investigators in the Focal Thermal Ablation Registration study.

“Enrolling our first patient in this clinical study marks an important milestone for MagForce and is a significant step towards the approval of NanoTherm therapy for the treatment of prostate cancer patients in the US. The NanoTherm trial in prostate cancer is designed to provide definitive safety and effectiveness data on our innovative therapy. We are very confident that the data from our planned prostate cancer study will fulfill all requirements for commercial registrations,” commented Ben Lipps, CEO of MagForce AG and MagForce USA, Inc.

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