Bayer ready to begin longer-lasting Kogenate Phase I clinical trials

Bayer HealthCare Biological Products Division (BP) is to begin Phase I clinical trials of its longer-acting Kogenate product, the first factor VIII product of its kind to be granted permission by the FDA to be used in clinical trials for hemophilia.

The product, which uses PEGylated liposome technology licensed from Zilip-Pharma, represents an opportunity for a major breakthrough in hemophilia treatment based on a longer time of activity, which could result in weekly, or even less frequent, infusions in prophylaxis. Currently, individuals with hemophilia on prophylaxis infuse factor VIII product as often as three times per week.

This development programme follows an agreement between Bayer BP and Zilip-Pharma to develop and commercialise a longer-acting recombinant factor VIII product. The new Kogenate formulation will utilise Zilip-Pharma's proprietary PEGylated liposomal technology. Formulating the new product with PEGylated liposomes is expected to provide a longer time of activity in the body, resulting in less frequent infusions.

Liposomes have been used successfully with other approved pharmaceuticals. Previous clinical results obtained by Zilip-Pharma outside the US suggest a prolonged protection from bleeding episodes one week or more occurs when factor VIII, attached to liposomes, is administered to individuals with hemophilia A.

'Advancing the longer-acting Kogenate product through clinical development is one of our highest priorities,' said Joseph Akers, president, Bayer BP. 'We believe this product has the potential to dramatically shift current treatment paradigms while improving treatment convenience.'