Nautilus Biotech Begins Phase I Clinical Trial in the USA for Subcutaneous Belerofon(R), its Long-Lasting, Interferon-Alpha Drug

Apr 02, 2007, 01:00 ET from Nautilus Biotech

    PARIS, April 2 /PRNewswire/ -- Nautilus Biotech has announced that it
 has initiated a Phase I clinical trial for subcutaneous Belerofon(R), its
 long-lasting human Interferon (IFN) alpha. Belerofon has therapeutic
 potential for the treatment of a number of conditions, including chronic
 Hepatitis C.
     Following recent approval by the US Food and Drug Administration, the
 Phase I clinical trial is being held in Austin, Texas in the USA and
 involves six treatment groups of eight male and female volunteers, aged 18
 to 50 years. The trial is an open-label, ascending dose study of four doses
 of subcutaneous (SC) Belerofon, which will be compared to SC administered
 IntronA(R) (a Schering-Plough product) and Pegasys(R) (pegylated Interferon
 alfa-2a (40KD), a Roche product).
     The primary objective of the trial is to evaluate SC Belerofon in
 healthy adult subjects, 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 Q3 2007.
     Belerofon is an engineered variant of IFN-alpha. It has a single point
 mutation for lower sensitivity to protease-mediated degradation, unchanged
 molecular weight and specific antiviral activity compared to non-pegylated
 IFNs. 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.
     "We are confident that Belerofon has the potential to set a new Gold
 Standard Interferon in the treatment and management of Hepatitis C," said
 Nautilus Biotech's CEO, Manuel Vega. "The start of a clinical trial for
 subcutaneous Belerofon is a major milestone in our move to become a leading
 drug development company."
     "The commencement of a Phase I clinical trial for SC Belerofon
 represents an important development in our pipeline of novel engineered
 protein drugs," said Paul Martin, Nautilus Biotech's Vice President
 Strategy. "It demonstrates Nautilus Biotech's ability to move novel
 engineered proteins from design to the clinic quickly and efficiently."
     In addition to the injectable Belerofon evaluated in this clinical
 study, Nautilus Biotech has formulated lyophilized Belerofon together with
 inactive ingredients to produce enteric-coated tablets for oral
 administration and filed an IND for oral Belerofon in February 2007. All
 currently marketed Interferon alpha drugs are administered by injection.
     Notes to Editors:
     About Hepatitis C
     Hepatitis C (HCV) is the most prevalent liver disease in the world. HCV
 infection causes chronic inflammation in the liver that can lead to
 cirrhosis, liver failure, liver cancer or death. HCV infection represents a
 significant medical challenge worldwide. Currently, there is no vaccine
 that can prevent hepatitis C.
     According to the World Health Organization, more than 170 million
 people worldwide suffer from chronic HVC. With only half of all HCV
 patients benefiting from current therapy, there is considerable market
 potential for new medical solutions. The HCV market is expected to grow
 from $2.2 billion in 2005 to $4.4 billion in 2010 and $8.8 billion in 2015
 due to improved market penetration and better diagnosis rates (source:
     About Nautilus Biotech
     Nautilus Biotech is a drug discovery and development company with a
 pipeline of next-generation therapeutic proteins with superior
 pharmacological profiles that address unmet clinical needs. The company's
 protein engineering technology can significantly improve the
 pharmacological characteristics of important blockbuster protein drugs,
 offering improvements in drug stability and administration. The company is
 also creating proprietary 'third generation' therapeutic proteins which
 are, per se, suitable for oral administration.
     The therapeutic proteins market is currently valued at over $35bn, and
 growing at a rate of 10-15% per annum. Nautilus Biotech has created a
 portfolio of next-generation therapeutic proteins with improved profiles,
 including long-lasting Interferon alpha (Belerofon), hGH (Vitatropin(R)),
 Interferon beta, Erythropoietin, Interferon gamma, Clotting Factor IX (in
 collaboration with Wyeth Pharmaceuticals) and HMGB1 (in collaboration with
 Creabilis Therapeutics). Nautilus Biotech has established a strong
 intellectual property position covering enhanced versions of these
 multibillion dollars molecules and is rapidly moving these products into
 clinical development.
     Nautilus Biotech is a private company with headquarters in Genopole(R)
 biopark, (Evry, France). For more information about Nautilus Biotech visit
     Media Contact for Nautilus Biotech:
     Lorna Watson, Account Director
     Deborah Gaskell, Account Manager
     Tel: +44-207-268-3237

SOURCE Nautilus Biotech