DGAP-News: MagForce AG / Key word(s): Study
02.07.2018 / 09:30
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MagForce Announces Enrollment of First Patient in its Pivotal, Three-Stage, Single-Arm Study of Focal Ablation of Prostate Cancer with NanoTherm Therapy
Berlin, Germany, and Nevada, USA, July 2, 2018 – MagForce AG (Frankfurt, Scale, Xetra: MF6, ISIN: DE000A0HGQF5), a leading medical device company in the field of nanomedicine focused on oncology, together with its subsidiary MagForce USA, Inc. today 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 USA. 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.
About Active Surveillance Progams
Within the past two decades, Active Surveillance Programs have been developed in the USA to follow the slow growth of Prostate Cancer in order to avoid the side effects of definitive therapy (radiation or surgery), for as long as possible. Currently, there are over 250 Active Surveillance Programs in the USA. Active Surveillance is the merging of watchful waiting and active management into a program that is interactive for the patient, ultimately allowing a man diagnosed with Prostate Cancer to monitor his disease and have the highest quality of life possible while delaying or even completely avoiding invasive treatments.
For the past decade, these Active Surveillance Programs have been seeking a focal therapy which would ablate the small tumors that have progressed to the intermediate risk stage because approximately 60% of the patients in Active Surveillance Programs who have participated in these programs for an extended period of time require definitive therapy such as whole gland surgery or radiation.
About MagForce AG and MagForce USA, Inc.
MagForce AG, listed in the Scale segment of the Frankfurt Stock Exchange (MF6, ISIN: DE000A0HGQF5), together with its subsidiary MagForce USA, Inc. is a leading medical device company in the field of nanomedicine focused on oncology. The Group’s proprietary NanoTherm(R) therapy enables the targeted treatment of solid tumors through the intratumoral generation of heat via activation of superparamagnetic nanoparticles.
NanoTherm(R), NanoPlan(R), and NanoActivator(R) are components of the therapy and have received EU-wide regulatory approval as medical devices for the treatment of brain tumors. MagForce, NanoTherm, NanoPlan, and NanoActivator are trademarks of MagForce AG in selected countries.
For more information, please visit: www.magforce.com.
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This release may contain forward-looking statements and information which may be identified by formulations using terms such as “expects”, “aims”, “anticipates”, “intends”, “plans”, “believes”, “seeks”, “estimates” or “will”. Such forward-looking statements are based on our current expectations and certain assumptions, which may be subject to a variety of risks and uncertainties. The results actually achieved by MagForce AG may substantially differ from these forward-looking statements. MagForce AG assumes no obligation to update these forward-looking statements or to correct them in case of developments, which differ from those, anticipated.
Barbara von Frankenberg
02.07.2018 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
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