The trial will examine four doses of subcutaneous (SC) Belerofon, which will be compared to SC administered IntronA, manufactured by Schering-Plough and Pegasys, manufactured by Roche.
The primary objective of the trial is to evaluate SC Belerofon for safety, tolerability and pharmacokinetics in comparison with IntronA and Pegasys. The second objective is to evaluate the comparative pharmacodynamics of the three products. Nautilus Biotech expects initial results from the trial to be available during the third quarter of 2007.
Belerofon is an engineered variant of human interferon (IFN) alpha. Following subcutaneous administration in animals, SC Belerofon shows a longer half-life and subsequently improved exposure profile compared to native IFN alpha and pegylated derivatives.
In addition to injectable Belerofon, Nautilus Biotech has formulated an oral version of Belerofon which it filed for approval in February 2007. All currently marketed Interferon alpha drugs are administered by injection.