Flamel starts trials of Medusa interferon

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Flamel starts trials of Medusa interferon

20/12/2004 - Medusa formulation of interferon alpha enters clinical trials,

could rival PEG products.

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 interferon, 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.