OctoPlus Announces Publication of Phase I Locteron Results in the Journal of Interferon and Cytokine Research
LEIDEN, The Netherlands, March 12, 2008-- OctoPlus N.V. ("OctoPlus" or "the Company") (Euronext: OCTO), the drug delivery and development company, announces today the publication of results from its Phase I study with Locteron®, its controlled-release formulation of alfa interferon for the treatment of chronic hepatitis C, in the current issue of the Journal of Interferon & Cytokine Research. In the randomised Phase I trial, the administration of Locteron demonstrated bioactivity over a two-week period and resulted in flu-like symptoms that were less frequent, milder and of a shorter duration in a head-to-head comparison with PEG-Intron®, the standard of care used as the control arm in the study.
OctoPlus also announces that updated results from its SELECT-1 Phase IIa trial of Locteron have been selected for presentation at the 43rd Annual Meeting of the European Association for the Study of the Liver (EASL) conference April 23-27, 2008 in Milan, Italy.
Phase I Publication The Phase I results were reported in the Journal of Interferon & Cytokine Research under the title "Novel Controlled-Release Lemna-Derived IFN-alfa 2b (Locteron): Pharmacokinetics, Pharmacodynamics, and Tolerability in a Phase 1 Clinical Trial" (28:113-122 (2008) by De Leede et al.).
The Phase I dose escalation study was designed to evaluate safety, pharmacokinetics and biomarker response of Locteron in comparison with PEG-Intron in healthy volunteers. The results show that Locteron, given as single doses to healthy volunteers, was well tolerated and safe. They confirm a gradual release of alfa interferon after injection, thus avoiding both high peak and low trough plasma levels. Flu-like symptoms among the groups receiving Locteron in the study were reported to be less frequent, less severe and of shorter duration than in the subjects receiving PEG-Intron. The pharmacokinetics and biomarker response profile of Locteron support the once-every-two-weeks dosing regimen of this product.
For further information, please contact: Rianne Roukema, Corporate Communications: telephone number +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 reduce side effects, improve patient compliance and provide a more convenient once-every-two-week dosing schedule compared with current therapies. Locteron is currently in Phase II trials. OctoPlus and its co-development partner Biolex Therapeutics plan to commence SELECT-2, a Phase IIb trial with 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.
Locteron combines OctoPlus' proprietary PolyActive(TM) drug delivery technology with BLX-883, a recombinant alfa interferon produced by Biolex Therapeutics in its patented LEX System(SM). Locteron is produced in OctoPlus' cGMP manufacturing facilities in Leiden, the Netherlands. 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. OctoPlus' pipeline consists of 5 products in pre-clinical and clinical development. The lead product is Locteron, a controlled-release formulation of interferon alfa for the treatment of chronic hepatitis C, which the Company is co-developing with Biolex Therapeutics. Locteron is currently in Phase II clinical studies. Furthermore, the pipeline comprises a product candidate for the treatment of chronic middle ear infection, which is in Phase II clinical development, a pre-clinical GLP-1 analogue product candidate for the treatment of diabetes type 2 and two pre-clinical-stage single-shot vaccines. In addition, OctoPlus is a European 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. The earnings and expertise that the Company derives from rendering formulation and manufacturing services help to support the Company's own drug development programs. OctoPlus is listed on Euronext Amsterdam by NYSE Euronext under the symbol OCTO. For more information about OctoPlus, please visit the website on 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.
Posted: March 2008