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Nautilus Biotech Receives FDA Approval for Phase 1 Clinical Trial in the USA for Oral Belerofon(R), its Long-Lasting, Interferon-Alpha Drug


5/21/2007 12:07:50 PM

PARIS, May 21 /PRNewswire/ -- Nautilus Biotech, a leading biotechnology company, has announced that it has received clearance from the US Food and Drug Administration (FDA) to carry out a Phase 1 clinical trial for Oral Belerofon(R) in the USA.

(Photo: http://www.newscom.com/cgi-bin/prnh/20070521/257054 )

Belerofon, a proprietary variant of human Interferon-alpha with a single amino acid replacement, has been designed by Nautilus Biotech 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 (SC) Belerofon began in Texas, USA last month and the results of the trial are expected to be completed in Q3 2007. In February Nautilus Biotech submitted an Investigational New Drug (IND) application for oral Belerofon to the FDA.

Oral Belerofon is the same molecular entity as SC Belerofon, but it has been formulated to be administered by mouth. In animal models, appropriate oral doses have shown that Belerofon can be absorbed from the intestine into the bloodstream and reaches blood levels comparable to those obtained by subcutaneously injected Interferon-alpha products. Oral Belerofon is formulated as enteric-coated tablets containing the lyophilized Belerofon protein.

The oral Belerofon phase I clinical trial will take place in the USA and will begin later in 2007. The trial will be an open-label, ascending dose study of four doses of oral Belerofon. The primary objective of the trial is to evaluate oral Belerofon in healthy adult subjects for safety, tolerability and pharmacokinetics.

Commenting on the announcement, Nautilus Biotech's CEO, Dr Manuel Vega, said: "We are pleased that the FDA has given us the go-ahead to start a Phase 1 clinical trial for oral Belerofon. This is an important milestone in the development of treatments for a range of therapeutic diseases - all currently marketed Interferon-alpha drugs are administered by injection and oral Belerofon is expected to result in improved safety and patient compliance".

Dr Paul Martin, Nautilus Biotech's Vice President Strategy, commented: "The development of an orally administered Interferon-alpha highlights the potential of Nautilus Biotech's technology platform. It represents the promise of a third generation of therapeutic protein drugs that can be taken more easily and have great commercial potential to replace established injectable products".

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 US$2.2 billion in 2005 to US$4.4 billion in 2010 and US$8.8 billion in 2015 due to improved market penetration and improved diagnosis rates (source: Datamonitor).

About Nautilus Biotech

Nautilus Biotech is a leading biotechnology company with a novel pipeline of next-generation therapeutic proteins with superior profiles. The Company's protein engineering technology improves the pharmacology profile and administration route of important blockbuster protein drugs.

The therapeutic proteins market is currently valued at over US$35bn, and is growing at a rate of 10-15% per annum. Nautilus Biotech has created a portfolio of next-generation products with improved profiles, including long-lasting Interferon alpha (Belerofon(R)), hGH (Vitatropin(R)), Interferon beta, Erythropoietin, Interferon gamma, Clotting Factor IX (in collaboration with Wyeth Pharmaceuticals) and HMGB1-BoxA (in collaboration with Creabilis Therapeutics). Nautilus Biotech has established a strong intellectual property position covering enhanced versions of these multibillion dollar 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 www.nautilusbiotech.com

Photo: http://www.newscom.com/cgi-bin/prnh/20070521/257054Nautilus Biotech

CONTACT: Contact: Deborah Gaskell, Account Manager, NorthbankCommunications, Tel: +44-(0)20-7268-3237, Email:d.gaskell@northbankcommunications.com; At Nautilus Biotech: Mediarelations: Dr Manuel Vega, Nautilus Biotech, 1 rue Pierre Fontaine, 91000Evry, France, Tel: +33-(0)1-60-87-54-60, Fax: +33-(0)1-60-87-54-61, Email:mvega@nautilusbiotech.com; At Northbank Communications, Lorna Watson,Account Director, Northbank Communications Ltd, 85 Tottenham Court Road,London, W1T 4TQ, UK, Tel: +44-207-268-3245, Fax: +44-207-268-3102, Email:l.watson@northbankcommunications.com



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