OctoPlus commences United States Phase IIa study with Locteron for
the treatment of hepatitis C
OctoPlus N.V. ("OctoPlus" or the "Company") (Euronext: OCTO), the
drug delivery and development company, announces today the
commencement of patient dosing in a Phase IIa study in the United
States with Locteron®, its controlled-release formulation of alfa
interferon for treatment of chronic hepatitis C (HCV). This study
will expand upon the favorable results of the recently completed
SELECT-1 Phase IIa study in Europe, which were presented at the
Annual Meeting of the American Association for the Study of Liver
Diseases (AASLD) conference in November. The study is being conducted
under an Investigational New Drug (IND) application filed with the US
Food and Drug Administration.
Joost Holthuis, CEO of OctoPlus, comments: "The results presented in
November demonstrate Locteron's favorable combination of efficacy and
improved tolerability at relatively high doses and we are pleased to
expand on these results with this US study. Generating clinical and
regulatory experience with Locteron in the United States and making a
direct comparison with the current standard of care in HCV will
enable us to confidently progress with the clinical development of a
best-in-class therapeutic for chronic hepatitis C patients."
Design of the United States Phase IIa study
The United States Phase IIa "PLUS" trial will evaluate up to 56
patients with chronic hepatitis C. The PLUS trial will evaluate
safety, tolerability, pharmacokinetics and viral kinetics of Locteron
and will provide US investigators first-hand experience with the
product. Locteron doses to be evaluated in the trial include 320 ug,
the lowest dose in the SELECT-1 study to show favorable viral
response, and 640 ug, the highest dose of Locteron studied to date.
The first phase of the PLUS trial will involve four weeks of
treatment and will compare the 320 ug dose of Locteron to
PEG-Intron®, each in combination with daily ribavirin, in a total of
16 chronic hepatitis C patients who have failed prior treatment. The
second phase of the trial will also include four weeks of treatment
and will compare the 640 ug dose of Locteron to PEG-Intron, each in
combination with daily ribavirin, in a total of 16 patients who have
failed prior treatment. The final phase will evaluate 12 weeks of
treatment of 24 treatment-naïve patients with the genotype-1 variant
of the virus, with patients randomised to receive either the 320 ug
dose of Locteron, the 640 ug dose of Locteron, or PEG-Intron, each in
combination with daily ribavirin.
Locteron clinical overview
Locteron is designed to be a best-in-class therapeutic for patients
with chronic hepatitis C, with the potential to reduce side effects,
improve patient compliance and provide a more convenient
once-every-two-week dosing schedule compared with current therapies.
The SELECT-1 Phase IIa study results presented in November 2007 show
a strong anti-viral response and patients receiving Locteron
experienced side effects that were less frequent and less severe than
those previously reported in clinical trials for the currently
marketed pegylated interferons and for a development-stage product,
Albuferon®. Successful completion of the PLUS trial will prepare for
dosing of Locteron for longer durations and in previously underserved
patient populations.
OctoPlus and its co-development partner Biolex Therapeutics plan to
commence SELECT-2, a Phase IIb trial with Locteron, in the fourth
quarter of 2008. The 12-week results of the Phase IIb trial will be
used as the basis for dose selection for the commencement of the
Phase III development program.
For further information, please contact:
Rianne Roukema, Corporate Communications: +31 (71) 524 1071
About Locteron
Locteron combines OctoPlus' proprietary PolyActive(TM) drug delivery
technology with BLX-883, a recombinant alfa interferon produced by
OctoPlus' co-development partner Biolex Therapeutics in its patented
LEX SystemSM. Locteron is produced in OctoPlus' cGMP manufacturing
facilities in Leiden, the Netherlands.
About OctoPlus
OctoPlus N.V. 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.
Our pipeline consists of 5 products in pre-clinical and clinical
development. Our lead product is Locteron, a controlled-release
formulation of interferon alfa for the treatment of chronic hepatitis
C, which we are co-developing with Biolex Therapeutics. Locteron is
currently in Phase II clinical studies. Furthermore, our pipeline
comprises a product candidate for the treatment of chronic middle ear
infection, which is in Phase II clinical development, a pre-clinical
GLP-1 analogue product candidate for the treatment of diabetes and
two pre-clinical-stage single-shot vaccines.
In addition, OctoPlus is a European leading 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. The
earnings and expertise that we derive from rendering formulation and
manufacturing services help to support our own drug development
programs.
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.
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to the business, financial performance and results of OctoPlus N.V.
and the industry in which it operates. These statements are based on
OctoPlus N.V.'s 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
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