OctoPlus' licensee Biolex makes third presentation at EASL confirming Locteron's superior product profile
(Thomson Reuters ONE) -
OctoPlus N.V. ("OctoPlus" or the "Company") (Euronext: OCTO) announces that its
licensee Biolex Therapeutics gave a presentation on Friday, during the 45th
International Liver Congress (EASL) in Austria, to present interim clinical
results from its Phase IIb clinical study with Locteron® named the "480 STUDY".
The main conclusion from the two posters and the oral presentation that were
given during the EASL conference is that Locteron dosed every other week
consistently achieves a reduction in flu-like sides effects while maintaining
antiviral efficacy comparable to the weekly dosed standard of care, providing
compelling proof that Locteron offers a significant improvement in interferon
therapy.
Simon Sturge, CEO of OctoPlus, says: "We are very excited about the results that
were presented at the EASL conference, which are an important validation of our
PolyActive® technology. Previous Locteron data had already confirmed that
PolyActive can achieve the desired controlled release profile, but these results
demonstrate the actual patient benefit that is the ultimate objective of our
technology."
For the detailed results that were published at the EASL conference we refer to
Biolex' press releases at www.biolex.com.
The "480 STUDY" is a Phase IIb trial that is being conducted in Europe and
Israel and includes 74 treatment-naïve hepatitis C patients with the genotype-1
variant of the virus. The 480 STUDY is designed to provide, in combination with
the SELECT-2 Phase IIb trial, patients for use in the EMPOWER analyses of
efficacy and tolerability of the 480 µg dose of Locteron versus PEG-Intron
(interim results from SELECT-2 and EMPOWER were also presented at the EASL
conference last week). The 480 STUDY includes the first clinical evaluation of
the drug configuration of Locteron planned for use in Phase III trials.
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.
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 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#1404921]
Click here for the press release in PDF: http://hugin.info/137076/R/1404921/358897.pdf
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Datum: 19.04.2010 - 01:30 Uhr
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