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New Once Weekly Oral Interferon Belerofon in Phase 1
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According to the Datamonitor, the HCV market is expected to grow to $4.4 billion in 2010 and $8.8 billion in 2015. Nautilus Biotech, a private drug development company, based in France, has commenced a clinical trial in the U.S., with its investigational subcutaneous Belerofon, an Interferon-alpha drug in the treatment of Hepatitis C.
French Pride - Nautilus Biotech Begins Clinical Trial In U.S For Hepatitis C Treatment, Belerofon
Nautilus Biotech, a private drug discovery and development company based in France, initiated a Phase I clinical trial in the U.S. for subcutaneous Belerofon, its long-lasting, Interferon-alpha drug, in the treatment of Hepatitis C.
Belerofon has therapeutic potential for the treatment of a number of conditions, including chronic Hepatitis C. Currently, there is no vaccine to prevent Hepatitis C. The Phase I trial will compare four doses of subcutaneous Belerofon, to subcutaneously administered IntronA, a Schering-Plough product and Roche's Pegasys. The initial results of the trial are expected to be released during the third quarter of 2007. Nautilus Biotech filed an Independent New Drug application for oral Belerofon in February 2007.
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Press Release
27 February 2007 - Nautilus Biotech announces IND filing for Belerofon, its oral, long-lasting, Interferon-alpha drug.
Paris, France, 27 February 2007, Nautilus Biotech has announced that it has submitted an Investigational New Drug (IND) filing to the US Food and Drug Administration (FDA) for oral Belerofon, its long-lasting human Interferon (IFN) alpha. Belerofon has therapeutic potential for the treatment of a number of conditions, including chronic Hepatitis C. The new drug will be administered orally - all currently marked interferon alpha drugs are administered by injection - resulting in improved safety and patient compliance.
This IND filing for oral Belerofon follows Nautilus Biotech's recent IND filing for injectable Belerofon in October 2006.
Belerofon is a designed 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 (SC) administration in animals, SC Belerofon shows a longer half-life and subsequently improved exposure profile compared to native IFN alpha and pegylated derivatives. Nautilus Biotech has formulated lyophilized Belerofon together with inactive ingredients to produce enteric coated tablets. When administered orally, Belerofon shows blood levels comparable to SC administered native IFN-alpha, which is not orally bioavailable. Oral bioavailability of Belerofon is based on its low sensitivity to protease degradation in the intestine which renders the molecule available for absorption into the bloodstream.
Oral Belerofon is one of a number of proteins being developed by Nautilus Biotech for oral administration and has been designed and developed using the company's proprietary technology for protein engineering.
"We are developing a pipeline of therapeutic proteins aimed at improving the quality of life of patients through improved safety and compliance. The IND for oral Belerofon is a major milestone in our commitment to develop highly innovative, high value and orally available protein drugs", said Nautilus Biotech's CEO, Manuel Vega.
"The IND for oral Belerofon represents a significant advance in protein therapeutics. The shift from subcutaneous injection to oral administration marks an important step in the creation of next-generation products and has wide applicability across many therapeutic protein families", said Paul Martin, Nautilus Biotech's Vice President Strategy.
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 ethird 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), 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 biopark, (Evry, France). For more information about Nautilus Biotech visit http://www.nautilusbiotech.com
For more information please contact:
At Nautilus Biotech
Dr Manuel Vega, CEO
Nautilus Biotech SA
1 rue Pierre Fontaine
91000 Evry, France
Tel: +33.(0)1.60.87.54.60
Fax: +(33) (0) 1 60 87 54 61
Email: mvega@nautilusbiotech.com
Media relations :
At Northbank Communications
Lorna Watson, Account Director
Northbank Communications
85 Tottenham Court Road,
London, W1T 4TQ, UK;
Tel: +44 (0)20 7268 3245
Fax: +44 (0)20 7268 3102
Email: l.watson@northbankcommunications.com
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