DGAP-Ad-hoc: MagForce AG / Key word(s): Study
Disclosure of an insider information acc. to Article 17 MAR of the Regulation (EU) No 596/2014
MagForce AG: MagForce USA, Inc. has Received FDA's Approval to Proceed with Stage 2B with the Final Protocol of the Pivotal U.S. Study for the Focal Ablation of Prostate Cancer with the NanoTherm Therapy System
Berlin, Germany and Nevada, USA, November 5, 2021 - 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., announces that the U.S. Food and Drug Administration (FDA) has approved MagForce USA to proceed with Stage 2b of its pivotal U.S. study with the NanoTherm therapy system for the focal ablation of intermediate risk prostate cancer with the final clinical trial protocol. MagForce will immediately commence with Stage 2b. Patient screening procedures, and enrollment of eligible patients, as well as treatments are being expedited at MagForce's NanoTherm treatment centers.
The Stage 2b of the single-arm pivotal study is planned to evaluate the use of NanoTherm ablation for the treatment of prostate cancer patients with intermediate grade lesions. Up to 100 patients are planned to be treated in this stage and then return to active surveillance without definitive treatment, such as external beam radiation or prostatectomy. The subjects will have intermediate risk prostate cancer but their prostate cancer has progressed to a stage where a clinical review and treatment change is required. The trial is designed to demonstrate that the NanoTherm therapy system can focally ablate targeted prostate cancer lesions with minimal side effects.
Following the final protocol, MagForce will submit interim data packages at 15 and 30 patients treated for FDA review, whilst treatments continue. Based on the current plan and conditions set out by the FDA, the clinical trial is expected to be finished in summer 2022. Following trial completion, the interim data packages supplied will be updated and submitted to the FDA for their approval.
MagForce USA has implemented strict COVID-19 infection control procedures for staff and patients at its three outpatient treatment facilities. The Company does not currently expect major delays in the conduct and completion of the pivotal trial since MagForce USA will execute the trial in its own treatment centers. However, slowdowns could occur based on the trajectory and severity of COVID-19 infections and in case additional safety measures will be demanded by authorities. Such measures could delay the expected timelines.
- End of Insider Information -
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.
05-Nov-2021 CET/CEST The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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1246571 05-Nov-2021 CET/CEST