DGAP-News: 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 Ther

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

 

• Following FDA green-light, Stage 2b of the pivotal trial will begin immediately
• Patient screening and enrollment will be expedited and, like treatments, executed at NanoTherm treatment centers owned and operated by MagForce
• The clinical trial is expected to be completed in summer 2022, the interim data packages supplied will then be updated and submitted to the FDA for approval

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., announced today 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.

"We are very pleased that the FDA has greenlighted the final clinical trial protocol and we can now commence with Stage 2b of our pivotal US study. Importantly, we will be able to use targeted biopsy to assess efficacy. We have worked hard to successfully optimize our application method to be minimally invasive and highly accurate making our approach precisely targeted and able to fight the tumor from within without damaging the healthy surrounding tissue," said Ben Lipps, CEO of MagForce AG and MagForce USA, Inc. "In our studies to date, we have not seen any of the treatment-related side effects frequently shown with other therapies, such as sexual, urinary or gastrointestinal dysfunction or loss of energy. We are confident, that we will be able to confirm the encouraging results seen so far."

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.

The aim of Stage 2b is to confirm the favorable results seen in Stage 2a in a larger patient population, The Stage 2a results mirrored the results of Stage 1 and confirmed the highly favorable safety and tolerability profile. As expected, treatment with the NanoTherm therapy system in Stage 1 and Stage 2a showed no unanticipated or serious adverse events and only minimal treatment-related side effects, which were tolerable and similar to those commonly associated with biopsies.

Another goal of Stage 2a was to improve the accuracy of instillation. This was successfully achieved with 92 percent coverage of the clinical target volume (CTV), resulting in a greater NanoTherm particle mass in the CTV. Due to this good coverage, all patients had sufficient deposit heating during the activation and pathologically confirmed ablation in the CTV, including the cancer present there. At the same time, there was no indication of ablation beyond 1 to 2 mm of the NanoTherm deposit in the surrounding healthy tissue, demonstrating the safety of this focal therapy.

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.

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 therapy system 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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Disclaimer

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.

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