OctoPlus presents positive Phase IIa study results for Locteron in
hepatitis C at AASLD conference
OctoPlus N.V. ("OctoPlus") (Euronext: OCTO), the drug delivery and
development company, announces that full and complete results from
its successful SELECT-1 Phase IIa clinical trial of Locteron(TM) for
the treatment of chronic hepatitis C will be presented today at the
58th Annual Meeting of the American Association for the Study of
Liver Diseases (AASLD).
Viral kinetic modeling of the SELECT-1 results by Eva Herrmann, Ph.D.
and Stefan Zeuzem, M.D. of Saarland University Hospital,
Homburg/Saar, Germany, demonstrated a statistically significant dose
response. The study results also showed that 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
OctoPlus is co-developing Locteron with its partner Biolex
Therapeutics. SELECT-1 (Safety and Efficacy of Locteron: European
Clinical Trial-1) was designed to evaluate four different doses of
Locteron, 160, 320, 480 and 640 micrograms (ug), administered
once-every-two-weeks in combination with ribavirin administered
orally twice per day in 32 treatment-naïve hepatitis C patients with
the genotype-1 variant of the virus.
SELECT-1 results demonstrate Locteron's strong antiviral effect:
- A statistically significant dose response was observed in the
study, and viral kinetic modeling by Drs. Herrmann and Zeuzem also
demonstrated a statistically significant reduction in viral RNA
during the entire 12-week treatment period. Specifically the dose
effect was associated with mean and maximal antiviral efficiency of
Locteron (p=0.003 and p=0.006, respectively;
- Average viral reduction after 12 weeks of treatment was greater
than four logs for each of the 640, 480 and 320 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
results compare favorably with results previously reported in
clinical trials for the currently marketed pegylated interferon alfa
products and for Albuferon for which EVR rates ranging from
approximately 74% to 90% in clinical trials have been reported.
SELECT-1 results confirm Locteron's superior tolerability:
- Locteron was well tolerated at all doses.
- Approximately 90% of adverse events were rated as mild.
- There were no serious adverse events in the 160, 320, and 480 ug
- There was one serious adverse event in the 640 ug cohort. This was
a case of inflammation of the ear, which completely resolved.
The majority of the side effects experienced by patients treated with
Locteron in the SELECT-1 study appear to be less frequent and less
severe than the side effects reported in previous clinical trials for
pegylated interferons and Albuferon. For example, only one patient
(3%) in the SELECT-1 study receiving Locteron experienced a clinical
adverse event rated as severe, indicating an improvement over
previously reported incidences of 14% and 18% in clinical trials for
Pegasys® and Albuferon, respectively. In addition, serious adverse
events in SELECT-1 were limited to the one event discussed above.
Injection site reactions were reported in 41% of the patients in
SELECT-1. All injection site reactions were mild with the exception
of one patient in the 640 ug cohort who had a reaction rated as
moderate. The SELECT-1 results are within the range of the incidence
of injection site reactions reported in clinical trials of Intron®-A,
PEG-Intron and Pegasys of 49%, 75% and 22%, respectively.
For further information, please contact:
Rianne Roukema, Corporate Communications: +31 (71) 524 1071
Notes to editors:
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 SystemSM. Locteron is produced in OctoPlus' cGMP manufacturing
facilities in Leiden, the Netherlands.
OctoPlus and Biolex plan to commence SELECT-2, a Phase IIb trial of
Locteron in the middle 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.
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
successfully completed Phase IIa 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
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
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