OctoPlus announces publication of key Phase IIb results for Locteron which confirm Locteron's improved tolerability up to 60 weeks into the SELECT-2 study
(Thomson Reuters ONE) -
Additional tolerability results from two Phase IIb trials of Locteron to be
presented at AASLD conference next week
OctoPlus N.V. ("OctoPlus" or the "Company") (Euronext: OCTO) announces that its
licensee Biolex Therapeutics today has published positive interim results at
week 60 of the Phase IIb trial, 12 weeks after completion of 48 weeks of
treatment with Locteron(®). The results are consistent with the existing
clinical results for Locteron and confirm Locteron's improved tolerability
profile.
Simon Sturge, CEO of OctoPlus, says: "These positive results further demonstrate
the value of our PolyActive(® )technology and show that Locteron's targeted
benefits are sustained in the long term, up to 12 weeks after the end of
treatment. Based on increasing evidence we believe that interferon alpha will
remain a core component of future hepatitis C treatment regimens, and these
positive results position Locteron as a key product in hepatitis C therapy."
The following information was taken directly from Biolex' press release, for
detailed results we refer to www.biolex.com.
Biolex Therapeutics, Inc. announced positive efficacy, safety and tolerability
results from its 72-week SELECT-2 Phase 2b dose-finding Phase 2b trial of
Locteron, Biolex's lead product candidate for the treatment of hepatitis C. For
each of the three Locteron doses tested in SELECT-2, the percentage of patients
who maintained undetectable levels of virus at week 60 of the trial, 12 weeks
after completion of 48 weeks of treatment (SVR12), were comparable with or
exceeded the response rate for the PEG-Intron(®) control. As a result of its
controlled-release mechanism, Locteron was dosed half as frequently as PEG-
Intron. PEG-Intron is one of two currently marketed pegylated interferon
products for the treatment of hepatitis C, a market that currently exceeds US$
2.5 billion in worldwide sales.
Additional results from SELECT-2 demonstrated the substantial tolerability
advantages of Locteron. Patients treated with each of the three Locteron doses
in SELECT-2 reported a statistically significant reduction in flu-like adverse
events (p<0.001) compared to the PEG-Intron
group. Accordingly, Locteron patients in all three dose groups used less
concomitant medications (analgesics and antipyretics) than the PEG-Intron
patients during the study period. Lastly, patients receiving the two lower doses
of Locteron experienced lower rates of depression and discontinuations due to
adverse events than patients receiving PEG-Intron.
These findings from SELECT-2 are of particular importance as a survey of
hepatitis C patients published in the Journal of Viral Hepatitis in 2010 showed
that depression and flu-like symptoms were cited as the two most important
adverse events impacting patient adherence to treatment.
Response rates and tolerability results for SELECT-2 are outlined in the table
below.
SELECT-2 interim results
Locteron
640 ?g 480 ?g 320 ?g PEG-Intron
------------------------
(n=29) (n=29) (n=28) (n=30)
Patients achieving SVR 12(1) 45% 35% 36% 30%
Reduction in flu-like adverse events 69% 68% 71% n/a
Patients using analgesics 66% 48% 45% 73%
Discontinuations due to adverse events 21% 14% 14% 23%
( )
(1) Percentage of patients who maintained undetectable levels of virus at week
60 of the trial, 12 weeks after completion of 48 weeks of treatment.
"The strong viral response of Locteron achieved with once-every-two-week dosing
is an improvement over current interferons, and I am impressed by the
consistency of the flu-like effect across trials and different reporting
methodologies," said Nezam Afdhal, M.D., Chief of Hepatology at Beth Deaconess
Medical Center, Harvard Medical School. "The reduction in symptoms of depression
is quite promising and needs to be followed up in additional clinical
evaluation. The Locteron safety and tolerability results are clearly important
as recent clinical results demonstrate that interferon is likely to remain a
core component of future treatment regimens that incorporate the new direct-
acting anti-virals, highlighting the need for a more tolerable interferon to
reduce the side-effect burden on patients from these multi-drug combinations and
maximize their adherence to treatment."
AASLD presentation
Biolex also announced today that new tolerability data from two Phase 2b trials
of Locteron have been accepted for a late-breaker presentation on November
1, 2010 at the 61(st) Annual Meeting of the American Association for the Study
of Liver Diseases (AASLD) in Boston.
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#1456660]
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http://hugin.info/137076/R/1456660/396495.pdf
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originality of the information contained therein.
Source: OctoPlus N.V. via Thomson Reuters ONE
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Datum: 28.10.2010 - 14:28 Uhr
Sprache: Deutsch
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