FDA OKs Nautilus' Ph I Belerofon trial
Nautilus Biotech, a French biotechnology company, has received clearance from the US Food and Drug Administration to carry out a Phase I clinical trial for Oral Belerofon, a proprietary variant of human interferon-alpha with a single amino acid replacement, in the USA.
Belerofon has been designed by Nautilus to lower the susceptibility of interferon-alpha to proteolytic degradation and make it longer-lasting in serum. Belerofon is intended to be used in the treatment of a range of conditions, including chronic hepatitis C.
A Phase I clinical study for injectable, subcutaneous Belerofon began in Texas, USA, last month and the results of this are expected to be completed in third-quarter 2007. In February, Nautilus submitted an Investigational New Drug application for oral Belerofon to the FDA.
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