Flamel Tech initiates Medusa Phase I/II trial

French biopharmaceutical group Flamel Technologies SA, which is primarily focused on the development of two unique polymer-based delivery technologies for medical applications, Micropump and Medusa, has reported the first patient enrollment in a dose-escalating, randomized Phase I/II clinical study of its Medusa formulation of long-acting interferon alpha.

The study's main objective is to demonstrate the product's safety profile and maximum tolerable dose, as well as evaluate the pharmacokinetic profile of the long-acting interferon compared with the immediate-release product Viraferon (peginterferon alfa), manufactured by US drugmaker Schering-Plough for hepatitis C.

Gerard Soula, the group's chief executive, noted: "we believe this formulation could challenge the PEG version of interferon, by making it a safer product."