Mologen, a Berlin based biotech company has initiated a clinical trial to test the efficacy of a DNA vaccine to protect dogs against Leishmaniasis. The study will take 7 months and is being performed by Mologen's Spanish subsidiary Mologen Molecular Medicines, S.L., Madrid, in collaboration with the Universitat Autonoma de Barcelona.

The vaccine, referred to as Leish-MIDGE-NLS, consists of Mologen's proprietary MIDGE DNA transfer Vectors which carry a selected combination of Leishmania genes. The vaccine is delivered into the skin of the dogs.

Mologen has already tested this vaccine successfully in the mouse model. The new study is designed to evaluate the efficacy of the vaccine in terms of protection of healthy dogs against the most severe form of the disease, visceral Leishmaniasis, as well as its effects on the immune response. Results will come out in the first quarter of 2004. The proof of vaccine efficacy in dogs, as important animal patients in view of public health, is regarded equivalent to clinical phase II of drug development in humans.

The market size for a dog vaccine against Leishmaniasis in relevant European countries is estimated to be worth 30-50 Mio Euro per year. This is only a fraction of revenues expected for a vaccine against the Leishmania infection in human patients, which is caused by the same parasite. The dog vaccine may be a strong door opener for regulatory approval of its human equivalent.