OctoPlus presents Positive Locteron Phase IIa Study Results at EASL Conference
LEIDEN, The Netherlands, April 24, 2008-OctoPlus N.V.
("OctoPlus") (Euronext: OCTO), the drug delivery and development
company, announces that extended results from its successful
SELECT-1 Phase IIa clinical trial of Locteron® for the
treatment of chronic hepatitis C (HCV) will be presented today at
the 43rd Annual Meeting of the European Association for the Study
of Liver Diseases (EASL). The poster presentation titled "Viral
Kinetics during Treatment with a Controlled-Release Recombinant
Interferon Alfa-2b in Genotype 1 Chronic Hepatitis C Patients" is
presented in Category 5h.
The study results presented at EASL show a strong and statistically
significant effect of Locteron on the amount of HCV virus
particles, and this effect increased with higher doses. Patients
receiving Locteron experienced side effects that were less frequent
and less severe than those previously reported in clinical trials
for other interferons. Biomarker results demonstrate Locteron's
biological activity with sustained presence of interferon alfa in
the body, and showed improvement of liver function in terms of
liver enzyme test results. SELECT-1 was a twelve-week trial
in 32 treatment-naïve patients with the genotype 1 variant of
the hepatitis C virus. The Phase IIa trial was designed to evaluate
four doses of Locteron administered once-every-two-weeks in
combination with the antiviral drug ribavirin. The SELECT-1 study
was completed in October 2007.
Viral kinetic modeling of the SELECT-1 results by Eva Herrmann,
Ph.D. of Saarland University, Homburg/Saar, Germany and Stefan
Zeuzem, M.D. of J.W. Goethe-University Hospital, Frankfurt/Main,
Germany, demonstrated a statistically significant dose response to
Locteron. Extended results presented at the EASL meeting also
included the effect of Locteron on the improvement of liver
function in terms of ALT liver enzyme profiles, and on the
biomarkers OAS and neopterin, each of which showed a dose-dependent
response to Locteron.
SELECT-1 results at EASL conference - A statistically significant
dose response was observed in the study, and viral kinetic modeling
by Dr. Herrmann and Prof. Zeuzem also demonstrated a statistically
significant reduction in viral RNA during the entire 12-week
treatment period. - Average viral reduction after 12 weeks of
treatment was greater than four logs for each of the 640, 480 and
320 microgram (ug) doses, compared to 1.8 logs for the lowest dose
of 160 ug. - The percentage of patients who achieved early
virologic response (EVR), defined as at least a two-log reduction
in hepatitis C virus, was 100% in the 640 and 480 ug dose cohorts
and 88% in the 320 ug dose cohort, compared to 37.5% in the 160 ug
dose cohort.
The biomarker results for safety and effect were as follows:
- Locteron resulted in a dose-dependent reduction in alanine
aminotransferase (ALT), an enzyme released by the liver into the
blood when the liver is damaged. - Locteron resulted in a
dose-dependent increase in oligoadenylate synthetase (OAS) and
neopterin, markers commonly associated with the biological effects
of interferon alfa. These biomarker results demonstrate that
Locteron is biologically active as an interferon alfa treatment and
that a marker for liver damage was reduced by the
therapy.
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 alfa
interferon 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.
Locteron is currently in Phase II clinical studies, a Phase IIa
PLUS study is currently ongoing in the United States. OctoPlus and
Biolex plan to commence SELECT-2, a Phase IIb trial of 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.
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 sustained-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 development. Furthermore, our pipeline
comprises a product for the treatment of chronic middle ear
infection, which is in Phase II development, a pre-clinical
GLP-1-analogue product for the treatment of diabetes and two
pre-clinical-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. This document may
contain certain forward-looking statements relating 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 version.
For further information, please contact: Rianne Roukema,
Corporate Communications: +31 (71) 524 1071, e-mail IR@octoplus.nl.
Posted: April 2008
