DGAP-News: MagForce Receives FDA Investigational Device Exemption Approval to Conduct a Clinical Trial with NanoTherm Therapy as Focal Ablation Treatment for Intermediate Risk Prostate Cancer
ACCESS Newswire
Berlin, Germany and Nevada, USA, February 10, 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 that it has received U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval 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 the Company's innovative NanoTherm therapy at selected medical centers in the US. MagForce anticipates to initiate patient enrollment in this study in the coming months.
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 advanced 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.
In order to conduct the study, MagForce has already installed two NanoActivator(R) 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.
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.
"We are delighted to announce that NanoTherm therapy has been granted FDA IDE approval. This is a significant milestone in the development of NanoTherm therapy for the treatment of prostate cancer patients in the USA and a significant step towards our goal - to supplement the current standard therapy with a less invasive, effective, and well-tolerated form of treatment. Potentially 50,000 to 100,000 men in active surveillance programs in the US could benefit from this focal therapy after registration," said Ben Lipps, Chief Executive Officer of MagForce AG and MagForce USA, Inc. "We are very excited to work with the teams of Ian M. Thompson Jr., MD and Dr. Dan W. Lin, with their exceptional experience and knowledge and I believe the registration trial will prove that NanoTherm therapy can fulfill the desired outcome."
MagForce's NanoTherm therapy has obtained a CE mark (European Certification) in the European Union to treat brain tumors and is already commercially available to brain tumor patients at renowned treatment centers in Germany.
Potential advantage of NanoTherm focal ablation therapy for patients enrolled in Prostate Cancer Active Surveillance Programs
Prostate Cancer, although one of the most frequently diagnosed forms of cancer in men, worldwide, is treatable, if detected early. According to estimates of the National Cancer Institute, around 230,000 new cases of Prostate Cancer have been diagnosed per year in the USA.
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.
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.
Consequently, MagForce expects to ablate these small lesions of cancer with focal NanoTherm therapy with minimal adverse effects. With successful NanoTherm treatment, it is anticipated that the patients can return to Active Surveillance and keep their quality of life. Clearly, there is a major medical need for a focal therapy with decreased side effects in the USA.
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, NanoPlan, and NanoActivator 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.
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.
Contact:
Barbara von Frankenberg Vice President Communications & Investor Relations T +49-30-308380-77 E-Mail: bfrankenberg@magforce.com
