The European Agency for the Evaluation of Medical Products (EMEA) has recently recommended granting orphan drug status for cell-based treatment for renal cancer by Mologen, a Berlin-based biotechnology company. Once awarded, this will be first of its kind approval in Europe for cell-based therapies.
The recommendation is the decisive milestone for achieving orphan drug status and is to take effect as soon as the European commission confirms the EMEA's recommendation. The EU confirmation is expected within the final quarter of 2006.
Orphan drug status ensures ten-year marketing exclusivity within the European Union. Moreover, the company is also guaranteed a simplified, accelerated and cost-effective approval procedure under the consultative guidance of the EMEA. The results already achieved indicate extremely good tolerability and affectivity in patients with metastasising renal cell carcinoma. In addition, the therapeutic approach has shown positive effects in a number of other cancer indications, said sources.
Sources said Mologen has developed this innovative cell-based gene therapy on the basis of injecting immunomodulated tumour cells. The tumour cells are transformed by gene modification and a combination of immunomodulated molecules into a very effective gene therapy. The patient is immunised using this drug. This type of activation of the immune system is a very promising approach towards overcoming the fatal tolerance of the patient's immune system against the cancer cells. Die Mologen AG is a listed biopharmaceutical company with headquarters in Berlin and on the basis of patented technologies (MIDGE and dSLIM), the company develops DNA-based vaccines and therapeutic agents for the prevention and treatment of a wide range of serious illnesses.