MagForce Nanotechnologies AG, the Berlin-based medical nanotechnology company, majority-owned by Nanostart AG, has submitted its application for the European regulatory approval of its Nano-Cancer® therapy.
The application is based on the successful results of recent clinical trials involving patients with recurrent glioblastoma, an especially aggressive form of brain tumor. The results of this efficacy study demonstrated that, by using Nano-Cancer® therapy accompanied by radiation therapy, the median survival time of patients following the first recurrence of glioblastoma could be more than doubled, from 6.2 months to 13.4 months, which is seen as a breakthrough in medical terms.
The product file for approval, consisting of some 20 volumes, has now been submitted to Medcert GmbH, the designated authority for the testing and certification of medical products. The management of MagForce anticipates that the testing procedure will take three to six months and thus should be completed by the end of May. Following successful completion, the company will be able to market its proprietary Nano-Cancer® therapy throughout the European Union.
In order to make the current testing and certification process as seamless as possible, MagForce worked closely with Medcert to proactively coordinate the methodology and procedures for its clinical trials.
In parallel with the procedure for European regulatory approval, MagForce is moving forward with preparations for its market launch. These include discussions with medical insurers on cost coverage for the therapy, with potential sales partners such as major medical technology corporations, and with cancer clinics. The company’s own sales and marketing organization is also being built up.
Dr. Andreas Jordan, founder and chief scientific officer of MagForce Nanotechnologies, commented, “After more than twenty years of research and development efforts, we now stand on the brink of regulatory approval. Ultimately, we aim to use our Nano-Cancer® therapy to treat all kinds of solid tumors.”
Nanostart CEO Marco Beckmann added, “Nano-Cancer® therapy is quickly moving toward market launch, and its market potential is enormous. We’re particularly pleased about the growing interest within the medical world in this completely new approach to cancer treatment.”
Professor Mauro Ferrari, the internationally recognized expert in the area of nanomedicine, praised the latest successes at MagForce: “I would like to congratulate and thank Dr. Jordan and his team at MagForce Nanotechnologies for their outstanding contribution to nanomedicine and cancer research. What MagForce could demonstrate with the study results is historical, nothing less than a real medical revolution: The physics-based, nanoparticle-enabled therapy is highly effective and it comes with minimal side effects for the patients – you simply can’t overestimate the importance of MagForce’s pioneering work. It is groundbreaking, for its own importance for extended survival of brain cancer patients, and perhaps even more in terms of broader implications for future thermal ablation therapies of other types of cancer.”