OctoPlus
Presents Positive Phase IIa Study Results for Locteron in Hepatitis C at AASLD
Conference Leiden,
Netherlands -- Marketwire -- November 6, 2007 -- 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 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, PhD, and Stefan Zeuzem,
MD, 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 product, Albuferon [albumin interferon].
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 (mcg) administered
once-every-two-weeks in combination
with ribavirin administered orally twice per day in 32 treatment-naive 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; Jonckheere-Terpstra-Test). • Average
viral reduction after 12 weeks of treatment was greater than four logs for each
of the 640, 480 and 320 mcg doses, compared
to 1.8 logs for the lowest dose of 160 mcg. • 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 mcg dose cohorts and 88% in
the 320 mcg dose cohort, compared to
37.5% in the 160 mcg 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 mcg dose cohorts. • There was one serious adverse
event in the 640 mcg 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 mcg 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,
PegIntron, and Pegasys of 49%, 75%, and 22%, respectively. 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 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. | 
