OctoPlus Announces That Locteron Interim Phase IIb Data Have Been Accepted For Oral And Poster Presentations At International Liver Congress In April

Main Category: Liver Disease / Hepatitis
Also Included In: Clinical Trials / Drug Trials
Article Date: 10 Feb 2010 - 4:00 PDT

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OctoPlus N.V. ("OctoPlus" or "the Company") (AMS: OCTO) announces today that its licensee Biolex Therapeutics has been accepted to present interim results from two ongoing Phase IIb studies with Locteron® at the 45th Liver Congress on 14 -18 April 2010 in Vienna, Austria.

Simon Sturge, CEO of OctoPlus, says: "We are delighted that the interim data for Locteron have been one of few to be selected for an oral presentation at this prestigious conference. We look forward to seeing the data and believe that this is very good news for the future of Locteron."

-- Biolex will present interim results after 12 weeks of treatment from its two Phase IIb studies for Locteron versus PEG-Intron® at the International Liver Congress in April, organised by the European Association for the Study of the Liver (EASL).

-- The objectives of the two Phase IIb trials are to demonstrate viral kinetics and response that is at least equivalent to the PEG-Intron control, while also achieving at least a 50% reduction in flu-like adverse events.

-- The data have been accepted for both oral and poster presentations. Under the strict rules of the conference, the results are currently embargoed until publication at the conference.

-- The "SELECT-2" Phase IIb study is being conducted in the United States and Europe in 116 treatment-naïve, genotype-1, chronic hepatitis C patients. Patients have been randomised into one of four dosing cohorts, the 320, 480 or 640 µg dose of Locteron (administered once every two weeks) or a control arm consisting of PEG-Intron (administered every week), with all patients receiving weight-based ribavirin. Patients will be treated for 48 weeks and will be followed for an additional 24 weeks to determine the sustained virologic response (SVR) rate. The SELECT-2 Phase IIb clinical study started in April 2009, and patient enrollment was completed in June 2009.

-- The second component of the planned Phase IIb trial program for Locteron, the "480 STUDY", is designed to provide clinical experience with the same Locteron configuration that is planned for use in Phase III trials. The 480 STUDY was also initiated last year, is being conducted in Europe and Israel, and will include at least 72 treatment-naïve hepatitis C patients with the genotype-1 variant of th e virus.

-- Locteron's expected product profile was tested by Biolex in extensive market research in the first half of 2009, and the research results suggested that the potential tolerability and dosing convenience advantages of Locteron support a substantial commercial opportunity. It is estimated that worldwide sales of interferon products for the treatment of hepatitis C will approach US$6 billion by 2016.

Under its agreement with Biolex, OctoPlus is eligible to:

-- Milestone payments which may exceed US$ 135 million
-- Royalties on net product sales.
-- An equity stake in Biolex.

About Locteron

Locteron is a controlled release formulation of interferon alpha for the treatment of chronic hepatitis C. Locteron combines OctoPlus' controlled release drug delivery technology PolyActive® with Biolex' interferon alpha and is the most advanced product in clinical development incorporating one of OctoPlus' proprietary drug delivery technologies. OctoPlus licensed its commercial rights to Locteron exclusively to Biolex in October 2008.

Source
OctoPlus

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