Published on November 4, 2009 at 3:12 AM
MagForce Nanotechnologies AG has successfully completed its single-arm clinical trial on the efficacy of thermotherapy using superparamagnetic nanoparticles in patients with recurrent glioblastoma. 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.
Source: MagForce Nanotechnologies AG