MagForce Nanotechnologies AG reaches primary study endpoint in pivotal glioblastoma study
BERLIN--(BUSINESS WIRE)--Nov 3, 2009 - 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.
* 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 Stock Exchange
ABOUT MAGFORCE NANOTECHNOLOGIES:
MagForce Nanotechnologies AG is one of the world's leading companies in the area of nanotechnology-based cancer treatment. Its patented Nano-Cancer® therapy allows the targeted destruction of tumors using superparamagnetic nanoparticles to generate heat. The nanotechnology from MagForce represents a revolutionary approach to the future successful treatment of solid tumors.
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 variety of risks and uncertainties. The results actually achieved by MagForce Nanotechnologies AG may substantially differ from these forward-looking statements. MagForce Nanotechnologies AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated.
Posted: November 2009