OctoPlus' Licensee Biolex Commences Phase IIb Study With Locteron
* Reuters is not responsible for the content in this press release.
LEIDEN, THE NETHERLANDS, Apr 20 (MARKET WIRE) --
OctoPlus N.V. ("OctoPlus" or "the Company") (EURONEXT: OCTO) announces
today that its licensee Biolex Therapeutics (see separate Biolex press
release on www.biolex.com) has commenced patient dosing in the SELECT-2
Phase IIb clinical study of Locteron(R), a controlled release formulation
of interferon alpha for the treatment of chronic hepatitis C. Locteron
combines OctoPlus' controlled release drug delivery technology
PolyActive(R) with Biolex' interferon alpha and is the most advanced
product in clinical development incorporating one of OctoPlus'
proprietary drug delivery technologies.
In October 2008 OctoPlus entered into an exclusive license and product
acquisition agreement with Biolex, worth up to EUR 100 million. As a
result, Biolex holds the full commercial rights to Locteron and is
responsible for development and commercialisation, and OctoPlus is paid by
Biolex to perform process development and to manufacture Locteron.
The Phase IIb study is being conducted in the United States and Europe in
100 treatment-naive, genotype-1, chronic hepatitis C patients. Patients
will be randomised into one of four dosing cohorts, the 320, 480 or 640
ug dose of Locteron (administered once every two weeks) or a control arm
consisting of PEG-Intron(R) (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: "Having announced earlier this
month the seventh company to sign an evaluation contract for OctoPlus'
technology, we are now delighted to report this progress in Locteron's
clinical development. The start of Biolex's Phase IIb study of Locteron is
a major milestone in the commercialisation of our proprietary PolyActive
technology. We look forward to the results of this large-scale study in
hepatitis C patients, which we hope will demonstrate Locteron's potential
improved tolerability profile as a result of its controlled release
mechanism."
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.
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(R) and PEG-Intron, and
the investigational product Albuferon(R) 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 require 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. Three clinical trials with
Locteron have been completed, and the results of the SELECT-1 Phase IIa
trial were presented at the 43rd Annual Meeting of the European
Association for the Study of the Liver in April 2008.
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.
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.
For further information, please contact:
Rianne Roukema
Corporate Communications
telephone number +31 (71) 524 1071
e-mail IR@octoplus.nl
Copyright 2009, Market Wire, All rights reserved.
-0-
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.



Follow Reuters