LEIDEN, NETHERLANDS--(Marketwire - April 19, 2010) - OctoPlus N.V. ("OctoPlus" or the "Company") (Euronext: OCTO) announces that its licensee Biolex Therapeutics gave a presentation on Friday, during the 45th International Liver Congress (EASL) in Austria, to present interim clinical results from its Phase IIb clinical study with Locteron® named the "480 STUDY".
The main conclusion from the two posters and the oral presentation that were given during the EASL conference is that Locteron dosed every other week consistently achieves a reduction in flu-like sides effects while maintaining antiviral efficacy comparable to the weekly dosed standard of care, providing compelling proof that Locteron offers a significant improvement in interferon therapy.
Simon Sturge, CEO of OctoPlus, says: "We are very excited about the results that were presented at the EASL conference, which are an important validation of our PolyActive® technology. Previous Locteron data had already confirmed that PolyActive can achieve the desired controlled release profile, but these results demonstrate the actual patient benefit that is the ultimate objective of our technology."
For the detailed results that were published at the EASL conference we refer to Biolex' press releases at www.biolex.com.
The "480 STUDY" is a Phase IIb trial that is being conducted in Europe and Israel and includes 74 treatment-naive hepatitis C patients with the genotype-1 variant of the virus. The 480 STUDY is designed to provide, in combination with the SELECT-2 Phase IIb trial, patients for use in the EMPOWER analyses of efficacy and tolerability of the 480 ug dose of Locteron versus PEG-Intron (interim results from SELECT-2 and EMPOWER were also presented at the EASL conference last week). The 480 STUDY includes the first clinical evaluation of the drug configuration of Locteron planned for use in Phase III trials.
Locteron is a controlled release formulation of interferon alpha for the treatment of chronic hepatitis C. Locteron combines OctoPlus' controlled release drug delivery technology PolyActive® with Biolex' interferon alpha and is the most advanced product in clinical development incorporating one of OctoPlus' proprietary drug delivery technologies. OctoPlus licensed its commercial rights to Locteron exclusively to Biolex in October 2008.
Locteron is an investigational therapeutic candidate and has not been approved for sale by the United States Food and Drug Administration or by any international regulatory agency.
OctoPlus is a drug delivery service company committed to the creation of improved pharmaceutical products that are based on OctoPlus' proprietary drug delivery technologies and have fewer side effects, improved patient convenience and a better efficacy/safety balance than existing therapies. OctoPlus focuses on the development of long-acting, controlled release versions of known protein therapeutics, other drugs, and vaccines on behalf of its clients.
The clinically most advanced product incorporating our technology is Biolex Therapeutics' lead product Locteron®, a controlled release formulation of interferon alpha for the treatment of chronic hepatitis C. OctoPlus licensed Locteron exclusively to Biolex in October 2008. Locteron is being manufactured for Biolex by OctoPlus and is currently in Phase IIb clinical studies.
In addition, OctoPlus is a leading European provider of advanced drug formulation and clinical scale manufacturing services to the pharmaceutical and biotechnology industries, with a focus on difficult-to-formulate active pharmaceutical ingredients.
OctoPlus is listed on Euronext Amsterdam by NYSE Euronext under the symbol OCTO. For more information about OctoPlus, please visit our website www.octoplus.nl.
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