[OctoPlus N.V. (NL) - OctoPlus announces publication of positive Locteron interim Phase IIb data
OctoPlus N.V. ("OctoPlus" or "the Company") (Euronext: OCTO) announces publication of an abstract containing preliminary Locteron® Phase IIb clinical results. The abstract was submitted by OctoPlus' licensee Biolex and has been accepted for an oral presentation at the 45th International Liver Congress on 16 April 2010 in Vienna, Austria. http://www.kenes.com/easl2010/orals/207.htm This abstract is the first of several publications on Locteron expected around the conference. The presentation at the conference will contain final results after 12 weeks of treatment.
Results after 4 weeks show:
- Flu-like symptoms were 63% less frequent for the Locteron patient cohort compared to the PEG-Intron patient cohort: flu-like symptoms occurred 94 times in the PEG-Intron® patient cohort and only 35 times in the Locteron patient cohort.
- Locteron had more rapid antiviral efficacy over the first four weeks.
- Neutrophil counts < 1000 occurred in only 6% of Locteron patients and in 9% of PEG-Intron patients; no neutrophil counts < 500 were reported in the first 4 weeks.
Simon Sturge, CEO of OctoPlus: "These are very exciting results, not only showing 63% less flu-like symptoms than PEG-Intron (currently marketed interferon), with reduced injection frequency, but also more rapid antiviral efficacy. This greatly increases our confidence of Locteron achieving its significant market potential."
The limitation of current interferon therapies is that many patients experience significant flu-like side effects. Locteron was designed to provide a controlled release of the alpha interferon with the objective of reducing the frequency and severity of these side effects, whilst retaining antiviral efficacy. It is expected that the market for alpha interferon products will approach US$6 billion in annual sales at the time Locteron reaches the market.
At the International Liver Congress in April, organised by the European Association for the Study of the Liver (EASL), Biolex will present interim results after 12 weeks of treatment from two Phase IIb studies for Locteron versus PEG-Intron®. The abstract published today refers to the "480 STUDY". In this study, efficacy and safety of 480ug Locteron dosed every other week was compared to PEG-Intron dosed weekly in treatment-naïve genotype 1 hepatitis C patients treated with weight-based ribavirin. The 12-week study is comprised of two panels, A and B. In Panel A, 19 subjects received 480ug Locteron and 23 subjects received PEG-Intron. Hepatitis C viral RNA was measured weekly for three weeks and then every other week. Final 12-week results from both Panel A and Panel B will be presented at the meeting. For further information, please contact: Rianne Roukema, Corporate Communications: telephone number +31 (71) 524 1071, or send an e-mail to Investor Relations at IR@octoplus.nl. About Locteron 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. About OctoPlus 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. This document may contain certain forward-looking statements relating to the business, financial performance and results of OctoPlus and the industry in which it operates. These statements are based on OctoPlus' current plans, estimates and projections, as well as its expectations of external conditions and events. In particular the words "expect", "anticipate", "predict", "estimate", "project", "plan", "may", "should", "would", "will", "intend", "believe" and similar expressions are intended to identify forward-looking statements. We caution investors that a number of important factors, and the inherent risks and uncertainties that such statements involve, could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements. In the event of any inconsistency between an English version and a Dutch version of this document, the English version will prevail over the Dutch version.
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Posted: March 2010