OctoPlus announces publication of positive Locteron interim Phase IIb data
(Thomson Reuters ONE) -
OctoPlus N.V. ("OctoPlus" or "the Company") (Euronext: OCTO) announces
publication of an abstract containing preliminary Locteron(®) Phase IIb clinical
results. The abstract was submitted by OctoPlus' licensee Biolex and has been
accepted for an oral presentation at the 45(th) International Liver Congress on
16 April 2010 in Vienna, Austria.
This abstract is the first of several publications on Locteron expected around
the conference. The presentation at the conference will contain final results
after 12 weeks of treatment.
Results after 4 weeks show:
- Flu-like symptoms were 63% less frequent for the Locteron patient
cohort compared to the PEG-Intron patient cohort: flu-like symptoms occurred 94
times in the PEG-Intron(®) patient cohort and only 35 times in the Locteron
patient cohort.
- Locteron had more rapid antiviral efficacy over the first four weeks.
- Neutrophil counts < 1000 occurred in only 6% of Locteron patients and
in 9% of PEG-Intron patients; no neutrophil counts < 500 were reported in the
first 4 weeks.
Simon Sturge, CEO of OctoPlus: "These are very exciting results, not only
showing 63% less flu-like symptoms than PEG-Intron (currently marketed
interferon), with reduced injection frequency, but also more rapid antiviral
efficacy. This greatly increases our confidence of Locteron achieving its
significant market potential."
The limitation of current interferon therapies is that many patients experience
significant flu-like side effects. Locteron was designed to provide a controlled
release of the alpha interferon with the objective of reducing the frequency and
severity of these side effects, whilst retaining antiviral efficacy. It is
expected that the market for alpha interferon products will approach US$6
billion in annual sales at the time Locteron reaches the market.
At the International Liver Congress in April, organised by the European
Association for the Study of the Liver (EASL), Biolex will present interim
results after 12 weeks of treatment from two Phase IIb studies for Locteron
versus PEG-Intron(®). The abstract published today refers to the "480 STUDY". In
this study, efficacy and safety of 480ug Locteron dosed every other week was
compared to PEG-Intron dosed weekly in treatment-naïve genotype 1 hepatitis C
patients treated with weight-based ribavirin. The 12-week study is comprised of
two panels, A and B. In Panel A, 19 subjects received 480ug Locteron and 23
subjects received PEG-Intron. Hepatitis C viral RNA was measured weekly for
three weeks and then every other week. Final 12-week results from both Panel A
and Panel B will be presented at the meeting.
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#1394529]
Click here for the press release in PDF: http://hugin.info/137076/R/1394529/351342.pdf
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Datum: 16.03.2010 - 09:00 Uhr
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