MagForce AG Announces Additional Supportive Data from Stage 2a of its Pivotal U.S. Single-Arm Study for the Focal Ablation of Intermediate Risk Prostate Cancer with the NanoTherm Therapy System

DGAP-News: MagForce AG

/ Key word(s): Study

26.04.2021 / 08:45

The issuer is solely responsible for the content of this announcement.

MagForce Announces Additional Supportive Data from Stage 2a of its Pivotal U.S. Single-Arm Study for the Focal Ablation of Intermediate Risk Prostate Cancer with the NanoTherm Therapy System

Further analysis of the Stage 2a results confirm positive initial findings published in February of this year – treatment-related side effects remained minimal and tolerable with the streamlined procedure

– Ablation-analysis showed well-defined ablation and cell death in the area of the nanoparticle deposit, with minimum tissue damage outside 2 to 4 mm from the deposit edge

– Despite ongoing restrictions due to COVID-19, Stage 2b is actively enrolling patients and MagForce expects start of Stage 2b still this quarter

Berlin, Germany, and Nevada, USA, April 26, 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., today announced additional supportive data from Stage 2a of its pivotal U.S. study with the NanoTherm therapy system for the focal ablation of intermediate risk prostate cancer.

Further analysis of the Stage 2a results confirmed the initial findings of a 10-patient cohort. Results showed that only the expected minimal treatment-related side effects, which are tolerable and similar to those observed in Stage 1 with an accelerated procedure, could be maintained in the streamlined procedure. The favorable safety and tolerability profile demonstrated in Stage 1 was also confirmed. Upon FDA approval, this streamlined procedure will allow patient treatment to be completed within a single day.

Results of focal treatment effectivity remain extremely reassuring. Ablation-analysis furthermore showed well-defined ablation and cell death in the region of the nanoparticle deposit, with minimum tissue damage outside 2 to 4 mm from the deposit edge. It was once again confirmed that the newly developed minimally invasive procedure places the NanoTherm particles in a clinical targeted volume (CTV) of less than 2 to 4 cc of volume in the human prostate and provides for a focal ablation therapy. By modifying the thixotropic nature of the NanoTherm particles, an increase in viscosity of 100 times was achieved, which allowed NanoTherm to remain better at the reverse biopsy instillation site and provide time for the NanoTherm conjugation to occur, stabilizing the NanoTherm particles in the CTV. Compared to Stage 1, MagForce was able to improve the accuracy of instillation in Stage 2a to more than 90%, resulting in a greater NanoTherm particle mass in the targeted area.

Study Stage 1 Stage 2a Stage 2a vs Stage 1
CTV – intended clinical target
% of CTV filled with Iron (Fe)
34.9% 92.4% More NanoTherm particle mass in
    targeted area
Standard deviation (SD) 16,9% 5.4% lower SD indicates high accuracy of
    procedure
Concentrations of Iron (Fe) in ring from 2mm to 4mm from the edge of CTV Not measured   11mg Fe/cc Will not ablate or cause tissue damage        below 20mg Fe/cc

Table 1: comparative instillation results

The findings show only minimal treatment-related side effects, which were tolerable and similar to those commonly associated with biopsies. To minimize discomfort during the 50 minute activation procedure, the patient cooling system was optimized based on the patient’s size and weight.

“The already very encouraging initial findings are supported by the further analysis of the Stage 2a data. The study so far indicates that the optimized instillation procedure is minimally invasive and highly accurate making our approach precisely targeted and able to fight the tumor without damaging the healthy surrounding tissue,” said Ben Lipps, CEO of MagForce AG and MagForce USA, Inc. “These data are promising, and I am excited by what they could mean for men living with this disease. The benefits for this group of patients are tremendous. Therefore, we remain committed to bringing this therapeutic option to patients as expeditiously as possible.”

 

The clinical protocol for Stage 2b of the trial has been reviewed by the FDA and is actively recruiting patients while treatment effectiveness was evaluated in Stage 2a. Stage 2b will enroll up to 100 men in total. The study is expected to commence at MagForce’s Focal Treatment Center in Texas, the centers in Florida and Washington will be subsequently included in the study. Although one study site would be sufficient to handle the required number of patients for the trial, MagForce will treat patients at all three of its U.S. sites in order to ensure that treatment centers are operational for commercialization once the clinical study is concluded.

COVID-19 impact: While there are many restrictions that have been applied in the U.S. such as “Shelter at Home,” exemptions exist for healthcare workers, such as MagForce’s USA staff at the Company’s clinical facilities. Clearly MagForce USA can conduct the trial in its out-patient facilities and has developed COVID-19 infection control protocols for staff and study subjects. These additional safety measures have caused a certain delay, but MagForce is hopeful that the next and final Stage 2b of the clinical trial will not be unduly delayed since MagForce USA will conduct the trial from its own treatment centers. With this in mind, as a secondary effect, MagForce USA has experienced therapy assessment delay due to delays at diagnostic laboratories as a result of short staffing and the increase of necessary clinical safety procedures. Nevertheless, we do not anticipate significant delays in our development timelines.
 

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 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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