Nautilus Biotech begins Phase I clinical trial in the USA for subcutaneous Belerofon(R) its long-lasting, Interferon-alpha drug.

Nautilus Biotech has announced that it has initiated a Phase I clinical trial for subcutaneous Belerofon(R), its long-lasting human Interferon (IFN) alpha.

PARIS, France | Apr 2, 2007 | 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.

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: Datamonitor).

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.

SOURCE: Nautilus Biotech

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