OctoPlus announces positive Phase IIa efficacy and tolerability
results for Locteron in hepatitis C
OctoPlus N.V. (Euronext: OCTO), the drug delivery and development
company, announces today the successful completion of the Phase IIa
clinical study with its lead product Locteron(TM), a controlled
release interferon alfa product for the treatment of chronic
hepatitis C (HCV).
Results from this study confirm Locteron's potential to substantially
improve patient care in HCV. Safety data from the study show a
substantially improved tolerability profile for Locteron compared to
other interferon products on the market or in development. Efficacy
data from the study indicate Locteron's strong antiviral effect, with
100% of the patients achieving early virologic response in the two
highest dose groups. In addition, Locteron is a more convenient
therapy than existing treatments due to its controlled-release
profile, allowing for once every two weeks drug administration versus
the current once a week regimen. OctoPlus is co-developing Locteron
with its partner Biolex Therapeutics.
Joost Holthuis, CEO of OctoPlus, says: "We are excited that the
results of this study demonstrate Locteron's potential for a
convenient, safe and efficacious hepatitis C therapy with less side
effects than its competing products. In addition, we believe that the
emergence of new oral antiviral products, which are associated with
additional side effects, will further add to the opportunity for
Locteron to be the interferon of choice for future combination
therapy as a result of its potential for improved tolerability. We
are on schedule to proceed with the development plan for Locteron and
are preparing to commence a Phase IIb clinical study in the first
half of 2008."
Top-line results from the complete study confirm Locteron's strong
antiviral effect:
§ The dose response in antiviral effect that was observed
in the first three dose cohorts continued in the final cohort:
average viral reduction after 12 weeks of treatment was greater than
4 logs for the 320 microgram (ug), 480 ug and 640 ug dose cohorts,
and 1.8 logs for the 160 ug dose.
§ The early virologic response (EVR, defined as at least a
two-log reduction in hepatitis C virus after 12 weeks of treatment)
that was observed in the first three dose cohorts, also continued in
the final cohort: the percentage of patients who achieved this was
38% for the 160 ug dose, 88% for the 320 ug dose, and 100% for both
the 480 and 640 ug doses. These results compare favorably with
results for the currently marketed pegylated interferon alfa products
and for Albuferon(TM) for which EVR rates ranging from approximately
74% to 90% in clinical trials have been reported.
Top-line results from the complete study confirm substantial
tolerability improvement:
§ Locteron was well tolerated at all doses
§ Approximately 90% of adverse events that were
experienced were rated as mild
§ There were no serious adverse events in the 160 ug, 320
ug, and 480 ug dose cohorts
§ There was one serious adverse event in the 640 ug
cohort. This was a case of inflammation of the ear, which completely
resolved.
Complete and final results of the study, including viral kinetics and
pharmacokinetic results, will be presented at the Annual meeting of
the American Association for the Study of Liver Diseases (AASLD) in
Boston, USA, on November 6.
For further information, please contact:
Rianne Roukema, Corporate Communications: +31 (71) 524 1071
Notes to editors:
About Locteron
Locteron is designed to be a best-in-class therapeutic for patients
with chronic hepatitis C, with the potential to induce less side
effects, improve patient compliance and provide a more convenient
once every two week dosing schedule compared with current therapies.
Locteron combines OctoPlus' proprietary PolyActive(TM) drug delivery
technology with BLX-883, a recombinant interferon alfa produced by
OctoPlus' co-development partner Biolex Therapeutics in its patented
LEX System(SM). Locteron is produced in OctoPlus' cGMP manufacturing
facilities in Leiden, the Netherlands.
About hepatitis C
More than three million people in the United States, and more than
180 million people worldwide, are currently infected with hepatitis
C. The standard treatment for patients with chronic hepatitis C is
pegylated interferon alfa administered in combination with the
antiviral drug ribavirin. The currently available pegylated
interferon alfa products require administration once per week for up
to 48 weeks and are associated with substantial side effects,
particularly during the period following each administration.
Independent market research predicts that modified interferons will
continue to be a key component of combination therapy for hepatitis C
patients and is expected to be complementary with new agents under
development. These sources estimate that total interferon sales for
the treatment of hepatitis C will exceed $5 billion by 2014.
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 preclinical and clinical
development. Our lead product is Locteron, a sustained-release
formulation of interferon alfa for the treatment of chronic hepatitis
C, which we are co-developing with Biolex Therapeutics. Locteron has
completed Phase IIa clinical development. Furthermore, our pipeline
comprises a product candidate for the treatment of chronic middle ear
infection, which is in Phase II development, a pre-clinical GLP-1
product candidate for the treatment of diabetes and two
preclinical-stage single-shot vaccines.
In addition, OctoPlus is a 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 in
injectable formulations. 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 under the symbol OCTO. For
more information about OctoPlus, please visit our website
www.octoplus.nl.
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