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news.French biopharmaceutical firm Flamel Technologies has enrolled the first patient in a phase I/II study of its Medusa formulation of long-acting interferon-alpha for the treatment of hepatitis and hepatitis C.
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The hepatitis and hepatitis C product has been developed using Flamel’s Medusa technology, which is designed to deliver controlled-release formulations of therapeutic proteins.
The phase I/II study is designed to demonstrate the safety profile of the product and to define the maximum tolerable dose. The second objective of the study is to evaluate the pharmacokinetic profile of the long-acting interferon, compared with Schering-Plough’s immediate release product Viraferon.
Dr Gerard Soula, founder, president and CEO of Flamel Technologies, said: “We are excited by the results of our existing pre-clinical studies of our long-acting interferon alpha formulation in monkeys and are eager to confirm these results in humans. We believe this formulation could challenge the PEG version of interferon, by making it a safer product.”