MEDIGENE AND AVENTIS START CLINICAL TRIAL FOR VACCINE AGAINST MALIGNANT MELANOMA

05-Jul-2001

The biopharmaceutical company MediGene AG (NMarkt: MDG) announced today the start of a phase 1/2 clinical trial for a vaccine against malignant melanoma developed together with Aventis Pharma AG. The therapeutic vaccination is based on gene transfer by so-called adeno-associated viruses (AAV). For the achievement of this milestone MediGene received a payment of DM 2 million from Aventis Pharma.

The first step of the therapy against malignant melanoma is the excision of the tumor. For the production of the vaccine immune activating genes are then introduced into these tumor cells in the laboratory. This gene transfer is performed using non-pathogenic adeno-associated viruses. After a treatment stopping the further growth of the tumor cells the modified cells are administered to the patient. The goal of the therapeutic vaccination is to activate the immune defense and to eliminate any remaining tumor cells (metastases).

The study will be performed in several European countries and will include patients, which are diagnosed with melanoma stage IV and which have undergone immune-therapy and chemotherapy without results. The main aim of the clinical study is to test the tolerance of the vaccine. Under the terms of the co-operation agreement MediGene is responsible for the development of the AAV-technology. Both companies take on planning and realization of phase 1 and phase 2 clinical studies together. Aventis is responsible for the phase 3 clinical trials, registration and marketing.

„The key problem of any cancer therapy is the tolerance of the immune system towards metastases. With this vaccine we expect to enable the immune system to identify and eliminate all metastases”, explains Johanna Holldack, M.D., MediGene’s COO, and adds: „The aim of this study is to clarify the efficiency of our AAV-technology. When we have brought forward the so-called „proof of concept“, we will also use the AAV-technology for the treatment of further tumor diseases.“

Malignant Melanoma in its later stages is one of the least treatable forms of cancer, because it is resistant to radiotherapy and chemotherapy. In the major industrialized countries 75.000 new cases of malignant melanoma are presently diagnosed per year, and a doubling of the number of new diseases every 10 years has to be assumed. Therefore medical prognoses (Point of View, pp. 441, June 1998) expect therapeutic vaccines to become the dominant approach for the treatment of malignant melanoma in the next decades. Analysts expect a turnover potential of € 200 million per year for this novel tumor vaccine.

https://www.chemeurope.com/en/news/3778/medigene-and-aventis-start-clinical-trial-for-vaccine-against-malignant-melanoma.html