DGAP-Adhoc MagForce AG: MagForce USA, Inc. Announces Completion of Patient Treatment in Stage 2a of Pivotal U.S. Single-Arm Study for the Focal Ablation of Intermediate Risk Prostate Cancer with the NanoTherm Therapy System
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. Announces Completion of Patient Treatment in Stage 2a of Pivotal U.S. Single-Arm Study for the Focal Ablation of Intermediate Risk Prostate Cancer with the NanoTherm Therapy System
- Stage 2a confirms positive findings of stage 1 - only minimal and tolerable treatment-related side effects observed - also with streamlined procedure
- Preparations for stage 2b with three MagForce USA sites are underway, trial will focus on offering a treatment alternative to intermediate risk prostate cancer patients to that of definitive therapy
- Despite ongoing restrictions due to COVID-19, MagForce is hopeful that the next stage of the clinical trial will not be unduly delayed since MagForce USA will conduct the trial from its own treatment centers
Berlin February 8, 2021 - MagForce AG (Frankfurt, Scale, Xetra: MF6, ISIN: DE000A0HGQF5), a leading medical device company in the field of nanomedicine focused on oncology, announces that patient treatment in Stage 2a of its pivotal U.S. study with the NanoTherm therapy system for the focal ablation of intermediate risk prostate cancer has been completed.
Initial findings of Stage 2a showed in a 10-patients group that only the expected minimal treatment-related side effects, which are tolerable and similar to those observed in Stage 1 with an extended procedure, could be maintained in the streamlined procedure. The findings from Stage 1 demonstrated a favorable safety and tolerability profile as well as well-defined ablation and cell death in the region of the nanoparticle deposit. Upon FDA approval, this streamlined procedure will allow patient treatment to be completed within a single day.
MagForce now prepares the start of the final Stage 2b of the focal ablation study, which is expected in early Q2. Immediatedly upon FDA approval, MagForce will start commercialization, which is still expected for the second half of 2021, assuming that the COVID-19 situation eases in spring.
- End of Insider Information -
MagForce AG, Max-Planck-Straße 3, 12489 Berlin
Barbara von Frankenberg
Vice President Communications & Investor Relations
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.
08-Feb-2021 CET/CEST The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de
|Phone:||+49 (0)30 308 380 0|
|Fax:||+49 (0)30 308 380 99|
|Listed:||Regulated Unofficial Market in Berlin, Dusseldorf, Frankfurt (Scale), Stuttgart, Tradegate Exchange|
|EQS News ID:||1166633|
|End of Announcement||DGAP News Service|
1166633 08-Feb-2021 CET/CEST