Het Nederlandse biofarmaceutische bedrijf OctoPlus N.V. ("OctoPlus" of de "Onderneming") (Euronext: OCTO) kondigt aan dat zijn licentiepartner Biolex vrijdag tijdens het 45e International Liver Congress (EASL) in Oostenrijk een presentatie heeft gegeven met tussentijdse klinische resultaten van een Fase IIb studie met Locteron® die de "480 STUDY" wordt genoemd.

De belangrijkste conclusie uit de resultaten die in twee posters en een mondelinge presentatie tijdens het EASL congres werden gepubliceerd, is dat Locteron (toegediend om de week) consequent een afname laat zien in griepachtige bijwerkingen, bij een vergelijkbare antivirale effectiviteit, vergeleken met de standaardtherapie (die elke week wordt toegediend). Dit vormt overtuigend bewijs dat Locteron een significante verbetering biedt in interferon behandelingen.

Simon Sturge, CEO van OctoPlus: "Wij zijn verheugd met de resultaten die tijdens het EASL congres zijn gepresenteerd; dit is een belangrijke validatie van onze PolyActive® technologie. Eerdere Locteron resultaten hadden al laten zien dat PolyActive het gewenste profiel van langzame afgifte kan bereiken, maar deze resultaten zijn het bewijs dat hieruit ook een daadwerkelijk voordeel voor de patiënt kan worden behaald. En dat is het uiteindelijke doel van onze technologie."

Voor de gedetailleerde resultaten die tijdens het EASL congres zijn gepubliceerd verwijzen wij naar de persberichten van Biolex op www.biolex.com.
zie hieronder dit bericht.

De "480 STUDY" Fase IIb klinische studie met Locteron wordt uitgevoerd in Europa en Israël in 74 chronische hepatitis C patiënten, genotype-1, die niet eerder zijn behandeld. Het onderzoek is opgezet om samen met het SELECT-2 Fase IIb onderzoek patiënten te leveren voor de EMPOWER analyse van de effectiviteit en verdraagbaarheid van de 480 µg dosis van Locteron vergeleken met PEG-Intron (tussentijdse resultaten van SELECT-2 en EMPOWER werden ook gepresenteerd tijdens het EASL congres afgelopen week). Het "480 STUDY" onderzoek is de eerste klinische evaluatie van de configuratie van Locteron die waarschijnlijk in de Fase III onderzoek zal worden gebruikt.

Locteron
dosed once every two weeks demonstrated a comparable reduction in viral
load compared to once-weekly standard of care with 57% less flu-like adverse events
PITTSBORO, NORTH CAROLINA, April 16, 2010 - Biolex Therapeutics, Inc. announced
that interim results from EMPOWER, a prospectively designed analysis of results from two Phase 2b trials of Locteron®, were presented yesterday in a late-breaker session at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria. Locteron, controlled-release interferon alpha 2b, is designed to improve patient care
by providing a more convenient once-every-two week dosing schedule and by reducing the flu-like symptoms associated with pegylated interferons, the current standard of care. In the EMPOWER study, the 480 μg dose of Locteron demonstrated viral kinetics and response rates that were comparable to the PEG-Intron® control while also achieving a 57% reduction in flu-like adverse events.
The objective of the EMPOWER study was to test the hypothesis that the 480 ug dose of Locteron dosed once every two weeks reduces flu-like symptoms but retains equivalent efficacy compared to PEG-Intron (1.5 μg/kg, administered every week). The 133 patients in the EMPOWER study were enrolled in two contributing Phase 2b trials:
• SELECT-2, a Phase 2b dose-finding trial evaluating the 320, 480 or 640 μg doses of Locteron versus PEG-Intron. Interim results from SELECT-2 were also presented at EASL yesterday. SELECT-2 contributed a total of 59 Locteron 480 μg and PEGIntron patients to EMPOWER.
• The 480 STUDY, a Phase 2b trial evaluating the 480 μg dose of Locteron versus PEGIntron.
Interim results from the 480 STUDY will be presented in an oral presentation
at EASL later today. The 480 STUDY contributed 74 patients to EMPOWER.
All patients were treatment-naïve-genotype-1 subjects with chronic hepatitis C, and all patients were also treated with weight-based ribavirin. A total of 30 sites participated in the two trials (14 sites in the US, 11 in Europe, and five in Israel). All patients in EMPOWER have completed at least six weeks of study, and over 80% of the patients have completed 12 weeks of study.
Through six weeks of treatment, Locteron 480 μg administered once every two weeks demonstrated reductions in viral loads (mean changes in HCV RNA from baseline) that were somewhat more rapid than that achieved with PEG-Intron administered once per week. Rates of undetectable HCV RNA achieved after six weeks of treatment were 31% for Locteron 480μg and 19% for PEG-Intron. The currently available results after 12 weeks of treatment (a number of patients have not yet reached the 12-week time point) suggest comparable
reductions in mean HCV RNA and rates of undetectable HCV RNA for Locteron 480 μg and PEG-Intron.
In EMPOWER, flu-like adverse events were predefined to include arthralgia, chills, fever, headache, and myalgia. A substantial reduction in flu-like adverse events for patients treated with Locteron was evident even in the first week of the trial and continued through the 12- week time point available for evaluation. After six weeks of treatment, total flu-like adverse
events reported for Locteron 480 μg were 52% less than the total events reported for PEGIntron.
Available results after 12 weeks of treatment suggest total flu-like adverse events reported for Locteron 480 μg were 57% less than the total reported for PEG-Intron.
The EMPOWER results were presented by the lead author, Walker Long, MD, Chief Medical Officer and Vice President, Drug Development, Biolex Therapeutics, in the form of a poster titled “Q2Week Controlled-Release Interferon Alpha2b + Ribavirin Reduces Flu-like Symptoms >50% and Provides Equivalent Efficacy in Comparison to Weekly Pegylated Interferon Alpha2b + Ribavirin in Treatment-Naïve Genotype 1 Chronic Hepatitis C: Results from EMPOWER, a Randomized Open-Label 12-week Comparison in 133 Patients.”
“The EMPOWER study allows us to focus on the activity associated with one specific dose of Locteron and test our hypothesis that equivalent efficacy can be achieved while greatly reducing flu-like adverse events,” said Dr. Long. “These results exceed our expectations. We believe that the importance of reducing flu-like adverse events will grow with the advent of direct-acting virals and the shortening of therapy, due to the prevalence of these side effects during the first three months of treatment.”
Three serious adverse events were reported for Locteron 480 μg and three were reported for PEG–Intron. All events were expected labeled events for interferon alpha. Higher rates of mild or moderate (Grade 2 and Grade 3) reductions in measurements of white blood cell counts, platelets and neutrophils were observed for Locteron 480 μg compared to PEG-Intron,
while higher rates of mild or moderate reductions in measurements of hemoglobin were observed for PEG-Intron. There were no Grade 4 reductions in hematological measurements for either Locteron 480 μg or for PEG-Intron. There were no novel toxicities identified in either cohort of the trial.
Locteron is an investigational therapeutic candidate and has not been approved for sale by the United States Food and Drug Administration or by any international regulatory agency.

Locteron Overview
Locteron is a controlled-release interferon alpha designed to improve patient care in the treatment of hepatitis C through a more favorable side-effect profile and dosing convenience compared to existing pegylated interferon products. In contrast to Locteron’s controlledrelease mechanism, the currently approved products, Pegasys® and PEG-Intron, and the investigational product Zalbin™, are immediate-release products that lack a controlled-release
mechanism. Interferon alpha serves as the foundation of current combination therapy for hepatitis C patients. It is estimated that worldwide sales of interferon products for the treatment of hepatitis C will approach $6 billion by 2016.
Locteron incorporates an advanced controlled-release drug delivery technology that allows dosing once every two weeks, more convenient than Pegasys and PEG-Intron, each of which require dosing every week. More importantly, Locteron’s controlled-release mechanism results in the gradual release of interferon alpha 2b to patients over the duration of two weeks and avoids the early peak plasma levels of the active interferon that characterize the pegylated
interferons and Zalbin. This controlled-release mechanism is designed to reduce the frequency, duration and severity of flu-like symptoms commonly experienced by patients treated with pegylated interferons and with Zalbin.

media,
April 19 (Bloomberg) -- At Fred Poordad’s bustling hepatitis C clinic in the heart of Los Angeles, one in every five patients receives no treatment. They are waiting for a wave of new drugs, expected in the next 18 months, that may boost their chance at a cure by as much as 10-fold. The medicines also may bolster the prospects of Merck & Co., Vertex Pharmaceuticals Inc. and Johnson & Johnson, the companies in a race to get the first new treatment to the market in a decade. About half of patients can’t tolerate the side effects of existing therapies, which generate $2 billion annually in sales. The new drugs could expand the market to $10 billion in five years, said Geoff Porges, an analyst for Sanford C. Bernstein & Co. in New York.
Available by 2011
Merck, of Whitehouse Station, New Jersey; Vertex, based in Cambridge, Massachusetts; and its partner Johnson & Johnson, of New Brunswick, New Jersey, have said they expect results from final-stage clinical trials by the second half of 2010, with submission to U.S. regulators by year-end. Patients can expect the drugs to be available by 2011, executives said on April 16 at the annual meeting of the European Society for the Study of the Liver in Vienna.