Leiden, Netherlands, Apr 24, 2008 - (ABN Newswire) - OctoPlus N.V. ("OctoPlus") (Euronext: OCTO), the drug delivery and development company, announces that extended results from its successful SELECT-1 Phase IIa clinical trial of Locteron® for the treatment of chronic hepatitis C (HCV) will be presented today at the 43rd Annual Meeting of the European Association for the Study of Liver Diseases (EASL). The poster presentation titled "Viral Kinetics during Treatment with a Controlled-Release Recombinant Interferon Alfa-2b in Genotype 1 Chronic Hepatitis C Patients" is presented in Category 5h. The study results presented at EASL show a strong and statistically significant effect of Locteron on the amount of HCV virus particles, and this effect increased with higher doses. Patients receiving Locteron experienced side effects that were less frequent and less severe than those previously reported in clinical trials for other interferons. Biomarker results demonstrate Locteron's biological activity with sustained presence of interferon alfa in the body, and showed improvement of liver function in terms of liver enzyme test results. SELECT-1 was a twelve-week trial in 32 treatment-naïve patients with the genotype 1 variant of the hepatitis C virus. The Phase IIa trial was designed to evaluate four doses of Locteron administered once-every-two-weeks in combination with the antiviral drug ribavirin. The SELECT-1 study was completed in October 2007. Viral kinetic modeling of the SELECT-1 results by Eva Herrmann, Ph.D. of Saarland University, Homburg/Saar, Germany and Stefan Zeuzem, M.D. of J.W. Goethe-University Hospital, Frankfurt/Main, Germany, demonstrated a statistically significant dose response to Locteron. Extended results presented at the EASL meeting also included the effect of Locteron on the improvement of liver function in terms of ALT liver enzyme profiles, and on the biomarkers OAS and neopterin, each of which showed a dose-dependent response to Locteron. SELECT-1 results at EASL conference - A statistically significant dose response was observed in the study, and viral kinetic modeling by Dr. Herrmann and Prof. Zeuzem also demonstrated a statistically significant reduction in viral RNA during the entire 12-week treatment period. - Average viral reduction after 12 weeks of treatment was greater than four logs for each of the 640, 480 and 320 microgram (ug) doses, compared to 1.8 logs for the lowest dose of 160 ug. - The percentage of patients who achieved early virologic response (EVR), defined as at least a two-log reduction in hepatitis C virus, was 100% in the 640 and 480 ug dose cohorts and 88% in the 320 ug dose cohort, compared to 37.5% in the 160 ug dose cohort. The biomarker results for safety and effect were as follows: - Locteron resulted in a dose-dependent reduction in alanine aminotransferase (ALT), an enzyme released by the liver into the blood when the liver is damaged. - Locteron resulted in a dose-dependent increase in oligoadenylate synthetase (OAS) and neopterin, markers commonly associated with the biological effects of interferon alfa. These biomarker results demonstrate that Locteron is biologically active as an interferon alfa treatment and that a marker for liver damage was reduced by the therapy. For further information, please contact: Rianne Roukema, Corporate Communications: +31 (71) 524 1071, e-mail IR@octoplus.nl. About Locteron Locteron is designed to be a best-in-class therapeutic for patients with chronic hepatitis C, with the potential to induce less side effects, improve patient compliance and provide a more convenient once-every-two-week dosing schedule compared with current therapies. Locteron combines OctoPlus' proprietary PolyActive(TM) drug delivery technology with BLX-883, a recombinant alfa interferon produced by OctoPlus' co-development partner Biolex Therapeutics in its patented LEX System(SM). Locteron is produced in OctoPlus' cGMP manufacturing facilities in Leiden, the Netherlands. Locteron is currently in Phase II clinical studies, a Phase IIa PLUS study is currently ongoing in the United States. OctoPlus and Biolex plan to commence SELECT-2, a Phase IIb trial of Locteron in the fourth quarter of 2008. The 12-week results of the Phase IIb trial will be used as the basis for dose selection for the commencement of the Phase III development program. About OctoPlus OctoPlus N.V. is a product-oriented biopharmaceutical 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. Rather than seeking to discover novel drug candidates through early stage research activities, OctoPlus focuses on the development of long-acting, controlled release versions of known protein therapeutics, other drugs, and vaccines. Our pipeline consists of 5 products in pre-clinical and clinical development. Our lead product is Locteron, a sustained-release formulation of interferon alfa for the treatment of chronic hepatitis C, which we are co-developing with Biolex Therapeutics. Locteron is currently in Phase II clinical development. Furthermore, our pipeline comprises a product for the treatment of chronic middle ear infection, which is in Phase II development, a pre-clinical GLP-1-analogue product for the treatment of diabetes and two pre-clinical-stage single-shot vaccines. In addition, OctoPlus is a leading 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 in injectable formulations. The earnings and expertise that we derive from rendering formulation and manufacturing services help to support our own drug development programs. OctoPlus is listed on Euronext Amsterdam 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 N.V. and the industry in which it operates. These statements are based on OctoPlus N.V.'s 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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