Flamel starts trials of Medusa interferon
clinical trial of its Medusa drug delivery technology, used to
develop sustained-release formulations of therapeutic proteins.
The dose escalating Phase I/II study is looking at a Medusa formulation of the cytokine interferon alpha, used to treat hepatitis. The 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 the immediate release product Viraferon, which is manufactured by Schering-Plough.
The start of the trial is a much-needed boost to Flamel's Medusa programme, which suffered a setback earlier this year when Bristol-Myers Squibb dropped out of an agreement to license a Medusa-formulated insulin product called Basulin.
This nanoparticulate technology, used to improve the delivery of therapeutic proteins, has been held up as one of the main technology drivers behind the company.
Dr Gerard Soula, Flamel's CEO, said: "We are excited by the results of our existing preclinical 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."
PEG versions of insulin, sold by Schering-Plough as Peg-Intron and by Roche as Pegasys, have transformed the treatment of hepatitis by reducing the frequency of injections, increasing the efficacy of treatment and sutting side effects.
Medusa takes the form of a nanoparticle with the active protein to be delivered residing on its surface rather than inside. The primary advantage of this is that external presentation requires no use of solvents and other chemical processes that can reduce the proteins activity. The protein is injected subcutaneously and is slowly released from the surface of the nanoparticle and absorbed into the bloodstream.
The lead investigators in the new study are Professors Jean-Pierre Zarski (Grenoble hospital) and Christian Trepo (Hotel Dieu-Lyon hospital). The Phase I/II study will assess the safety, pharmacokinetics and certain pharmacodynamic parameters of the product after a single administration of drug.
