EndoTAG™-1

Attacking tumor blood vessels
EndoTAG™-1 represents an innovative therapeutic approach that unfolds its effect by both a targeted antivascular (against newly formed tumor blood vessels), and an anti-tumoral (directed against the tumor) mechanism. The drug candidate attaches itself selectively to newly developed, negatively charged tumor blood vessels, thus attacking only these blood vessels and not those in healthy tissue. Concurrently, EndoTAG™-1 prevents the formation of new vessels, which is expected to suppress further tumor growth.

EndoTAG™-1 is a combination of positively charged liposomes with the therapeutic substance paclitaxel embedded therein. MediGene assumes that direct destruction of the endothelial cells does not lead to any resistance to the therapeutic substance applied. This would solve a common problem inherent to existing chemotherapy. In addition, the EndoTAG™-1 concept is expected to provide a wide range of applications. Principally, it could be suited for the treatment of all types of solid tumors which have their own vascularization.

EndoTAG™-1 is MediGene's first product candidate derived from the EndoTAG™ platform technology. In Europe and the USA, EndoTAG™-1 has been granted orphan drug designation which allows benefits in development and approval procedures, and possibly even the commercialization of the product.

MediGene reported positive results for this drug candidate obtained in a controlled phase II clinical study in the indication pancreatic cancer. According to this, survival time and survival rates improved significantly for those patients treated with EndoTAG™-1 in combination with gemcitabine.

Furthermore, MediGene published the results of a clinical phase II study using EndoTAG™-1 for the treatment of triple negative breast cancer. The extensive data analyses of the three-arm trial confirms a positive efficacy trend of EndoTAG™-1 in combination with paclitaxel for the treatment of this difficult to treat type of cancer. From MediGene’s point of view, these positive results of the phase II-study with EndoTAG™-1 in triple negative breast cancer provide a second proof of concept.

Outlook 
MediGene will further push the shift of the manufacturing process from freeze-drying which has been applied up to now to spray-drying, in order to facilitate a considerably more efficient manufacturing process. MediGene is planning to conclude one or more partnerships for further development and future commercialization of EndoTAG™-1 in 2010. In the first six months of 2011, the initiation of a phase III trial for the indication of pancreatic cancer is planned.