AG has successfully completed its single-arm clinical trial on the efficacy
of thermotherapy using superparamagnetic nanoparticles in patients with recurrent
The primary study endpoint, which was to extend the median survival time following
tumor recurrence by three months compared to a historical control group, was
significantly exceeded in the actual results. The 59 patients evaluated to determine
the clinical efficacy of treatment with Nano-Cancer® therapy with accompanying
radiotherapy attained a median survival time following diagnosis of the first
tumor recurrence of 13.4 months* (99% confidence interval: 10.6-16.2 months).
Compared to the 6.2-month median survival time* following recurrence observed
in a recently published EORTC study with a total of 573 patients**, the survival
time with Nano-Cancer® therapy is statistically highly significant longer
(p-value < 0.01).
The results of the clinical trial will now form the basis for the conformity
assessment procedure required under the German Medical Devices Act (Medizinproduktegesetz).
The product file should be submitted as planned by year end to “MEDCERT
Zertifizierungs- und Prüfungsgesellschaft für die Medizin GmbH”,
a notified body for the certification of medical devices. Following successful
completion of the conformity assessment procedure for Nano-Cancer® therapy
and EC type testing of the magnetic field applicator, MagForce will be able
to market its Nano-Cancer® therapy throughout the European Union.
* Determined with the Kaplan-Meier method
** Stupp et al., Lancet Oncol 2009; 10:459-66
Announcement in accordance with section 17 of the General Terms and Conditions
of Deutsche Börse AG for the Regulated Unofficial Market on the Frankfurt