LEIDEN, THE NETHERLANDS--(Marketwire - June 29, 2009) - OctoPlus N.V. ("OctoPlus") (Euronext: OCTO) announces today that its licensee Biolex Therapeutics (see separate Biolex press release on www.biolex.com) has completed patient enrollment in its SELECT-2 Phase IIb clinical study of Locteron®, a controlled release formulation of interferon alpha for the treatment of chronic hepatitis C. OctoPlus licensed Locteron exclusively to Biolex in October 2008.
-- Biolex Therapeutics announced today that it has completed patient
enrollment in the SELECT-2 Phase IIb trial of Locteron.
-- Key results from SELECT-2 will be available during the fourth quarter
of this year.
-- 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.
-- Study design
-- The Phase IIb study is being conducted in the United States
and Europe in over 100 treatment-naïve, genotype-1, chronic
hepatitis C patients.
-- Patients are randomised into one of four dosing cohorts,
the 320, 480 or 640 µg dose of Locteron (administered once
every two weeks) or a control arm consisting of PEG-Intron®
(administered every week), with all patients receiving
weight-based ribavirin.
-- Patients will be treated for 48 weeks and will be followed for an
additional 24 weeks to determine the sustained virologic response
(SVR) rate.
-- The interim results after 12 weeks of treatment are expected to be
used as the basis for the selection of the Locteron dose(s) for Phase
III studies.
Simon Sturge, CEO of OctoPlus, comments: "We are very pleased with the clinical progress Biolex has made in the Phase IIb study with Locteron. This swift enrollment will enable the availability of key results from SELECT-2 during the fourth quarter of this year."
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.
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 interferon alpha designed to improve patient care in the treatment of hepatitis C through a more favorable side-effect profile and dosing convenience compared to existing pegylated interferon products. In contrast to Locteron's controlled release mechanism, the currently approved products Pegasys® and PEG-Intron, and the investigational product Albuferon® are immediate release products that lack a controlled release mechanism. Interferon alpha serves as the foundation of current combination therapy for hepatitis C patients, and all major hepatitis C drug candidates currently in clinical trials are being studied in combination with interferon alpha. It is estimated that worldwide sales of interferon products for the treatment of hepatitis C will approach US$ 6 billion by 2016.
Locteron combines OctoPlus' proprietary drug delivery technology PolyActive with BLX-883, a recombinant interferon alpha produced by Biolex in its patented LEX System(SM). Locteron is configured to allow dosing once every two weeks, more convenient than Pegasys and PEG-Intron, each of which requires dosing every week. More importantly, Locteron's controlled release mechanism results in the gradual release of interferon alpha 2b to patients over the duration of two weeks and avoids the early peak blood plasma levels of the active interferon that characterise pegylated interferons and Albuferon. This controlled release mechanism is designed to reduce the frequency, duration and severity of side effects, including flu-like symptoms, commonly experienced by patients treated with pegylated interferons and with Albuferon.
About Biolex Therapeutics
Biolex is a clinical-stage biopharmaceutical company that uses its patented LEX System(SM) to develop hard-to-make therapeutic proteins and to optimize monoclonal antibodies. The LEX System is a novel technology that genetically transforms the aquatic plant Lemna to enable the production of biologic product candidates.
About OctoPlus
OctoPlus 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 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.
Click here for the press release in PDF
http://hugin.info/137076/R/1325748/311905.pdf
For further information, please contact:
Rianne Roukema
Corporate Communications
+31 (71) 524 1071
IR@octoplus.nl
