Berlin, 2003-07-01

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 Autónoma 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 (see our press release of December 4, 2002). 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.



MIDGE DNA transfer technology

Mologen has developed and patented a non-viral DNA transfer technology that is referred to as MIDGE. MIDGE vectors consist of double stranded DNA, covalently closed at the ends by oligonucleotide hairpins. It is the only vector that exclusively contains the components needed to achieve gene expression in cells. It avoids superfluous and potentially harmful sequences and proteins in other naked DNA- or viral vectors.

One of the main advantages of MIDGE technology is that different chemicals can be attached to the end loops. By linking MIDGE vectors with functional molecules, the DNA can be targeted to specific cell types, whilst enabling it to escape the endosome to avoid degradation, and facilitating translocation to the cellular nucleus where transcription takes place. All these strategies result in a specific and more efficient expression of the therapeutic protein or antigen.

MIDGE-NLS vectors are linked to a peptide containing a Nuclear Localization Signal motif. These vectors are able to induce a strong Th1 or cellular type of immune response and have been shown to provide very efficient vaccination against diseases like Leishmaniasis where a Th1 type of response is required for protection.



About Leishmaniasis

Leishmaniasis is a disease caused by different species of the Leishmania genus, which is transmitted by sand flies. The clinical manifestations extend from self-healing cutaneous lesions to the most severe visceral form of the disease, the latter being fatal if untreated. The World Health Organization has identified leishmaniasis as a major public health problem with an estimated 12 million people affected and 1.5 to 2 million new cases of the disease arising each year. The disease is endemic through parts of Asia, Africa, Southern Europe, Mexico and Central and South America. With the advent of the HIV epidemic, leishmaniasis has surged as a reactivated infection in AIDS patients in many countries.

In Spain and the southwest of Europe, dogs are the main reservoir host of Leishmania. Epidemiology of the disease revealed that between 10 and 37% of dogs in the Mediterranean area are infected and develop the disease. Thus, eradication of the disease in dogs is considered one of the main targets to improve human health. Chemotherapy has only a modest effect and there is so far no effective and safe vaccine available against any form of clinical leishmaniasis.

Links:

World Health Organization - http://www.who.int/emc/diseases/leish/index.html


Our publication:
DNA vaccination with linear minimalistic (MIDGE) vectors confers protection against Leishmania major infection in mice. (Vaccine 2002 Dec 13;21(3-4):247-57)   Link: Medline Abstract

About Mologen

Mologen develops and uses new DNA-based technologies and products for the prevention and healing of illnesses. The focus of development work is the MIDGE technology, which has been patented by Mologen. With this technology, genetic information can be deployed as a drug safely and efficiently.

Mologen went public in 1998 as one of the first biotechnology companies in Germany. The company is headquartered in Berlin, Germany, with operations regarding vaccine development in Madrid, Spain. The shares of Mologen are traded in the Regulated Market on the Frankfurt Stock Exchange.

Contact: Matthias Reichel

e-mail: [email protected], Phone: +49-(30)-857 576-0, Fax: +49-(30)-857 576-50