News at CellGenix
CellGenix GmbH receives EU- orphan drug status for IdioVax® cancer vaccine
Freiburg, Nov. 18, 2004
Freiburg, Germany -- CellGenix GmbH announced today that its cancer vaccine IdioVax®, which is is in clinical trial phase 2, and is developed in cooperation with the University Hospital of Freiburg, has reveived orphan drug designation from the European Medicinal Agency (EMEA) for certain low-grade Non-Hodgkin´s indications, e.g. mantle cell lymphoma and follicular lymphoma as well as for multiple myeloma.
The decision of this positive opinion was announced on the November meeting of the Commitee for Orphan Medicinal Products (COMP) coming as a late present for CellGenix´s 10th anniversary which has been celebrated recently.
Prof. F. Rosenthal, CEO of CellGenix, said, "The EU Orphan Drug initiative provides a number of benefits to CellGenix. We are very pleased to take advantage of this innovative European program. IdioVax® is a very good example of a promising new type of cancer-therapeutic and the orphan drug designation will motivate CellGenix in its future work and efforts to combat the threats of blood cancer."
Orphan drug designation entitles CellGenix to exclusive marketing rights in the EU on IdioVax® for ten years following marketing approval and to apply for protocol assistance by EMEA to optimize drug development in preparing a dossier that will meet regulatory requirements. It also facilitates access to the Centralized Procedure for the application for marketing approval, fees associated with applying for marketing approval and protocol assistance are reduced, and application for an European Union research funding grant is enabled.
About Non-Hodkin´s Lymphomas (NHL) and Multiple Myeloma:
NHL and multiple myeloma form a heterogenous group of B-cell malignancies with differing patterns of behaviour to treatment. Despite the development of high-dose chemotherapeutics there is still no cure and the annual number of new cases in the EU is ~ 60 000 for NHL and ~ 20 000 for multiple myeloma.
About IdioVax®:
IdioVax® is a patient-specific tumor vaccine, codeveloped by CellGenix and the University Hospital of Freiburg, which is produced by recombinant DNA technology according to a highly sophisticated proprietary process, which allows for a quick and GMP-compliant manufacture. The derived vaccine is used to stimulate the patient´s immune system to recognize and attack cancer cells, which would normally persist untouched in the body. IdioVax® is currently in a clinical phase 2 trial and preliminary results are very promising. With the help of EMEAs scientific advice a phase 3 study is now designed.
About CellGenix:
CellGenix develops, manufactures and markets innovative and efficacious cell and protein products for the treatment of cancer and for tissue regeneration. It holds several production licenses and operates one of the most advanced GMP-facilities for cell therapy products in Europe. Its high-quality growth factors and cell culture reagents are being distributed worldwide.
