Locteron data presented at EASL conference show 65% reduction in flu-like side effects with comparable efficacy in hepatitis C
(Thomson Reuters ONE) -
OctoPlus N.V. ("OctoPlus" or the "Company") (Euronext: OCTO) announces that its
licensee Biolex Therapeutics has presented today, during the 45th International
Liver Congress (EASL) in Austria, a poster containing interim clinical results
after 36 weeks of treatment with Locteron® from its SELECT-2 Phase IIb clinical
study.
* The main conclusion from this poster is that Locteron dosed every other week
demonstrates comparable reduction in viral load compared to the weekly dosed
standard of care, while achieving a 65% reduction in flu-like adverse
events.
For detailed results we refer to Biolex' press release at www.biolex.com. The
poster will be available on the website of OctoPlus shortly. On 15 and 16 April
Biolex will present a second poster and an oral presentation during the EASL
conference.
The SELECT-2 Phase IIb clinical study with Locteron is being conducted in the
United States and Europe in 116 treatment-naïve, genotype-1, chronic hepatitis C
patients. Patients were 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 (1.5 µg/kg, 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. All patients in the trial have completed at least
36 weeks of study.
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(at)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.
[HUG#1403789]
Click here for the press release in PDF: http://hugin.info/137076/R/1403789/357984.pdf
Unternehmensinformation / Kurzprofil:
Datum: 15.04.2010 - 08:30 Uhr
Sprache: Deutsch
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