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Time-Released Interferon Drug: OctoPlus initiates Locteron Phase II clinical study in chronic hepatitis C
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29 2007, 11:16 PM EST
MARKETWIRE
Jan 30, 2007 LEIDEN, NETHERLANDS MARKET WIRE
OctoPlus N.V. (Euronext: OCTO), the drug delivery and development company, announces today the commencement of a Phase IIa study with LocteronTM, its controlled release formulation of alfa interferon for treatment of chronic hepatitis C. The Phase IIa study is designed to evaluate Locteron in combination with the anti-viral drug ribavirin in previously untreated chronic hepatitis C patients. Recruitment of patients is ongoing and dosing has started.
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. Results from the Phase I study, which was completed in April last year, showed that Locteron is both safe and successful in producing a gradual release over two weeks of alfa interferon after a single injection.
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.
Design of the Phase IIa study
The Phase IIa study, known as SELECT-1 (Safety and Efficacy of Locteron: European Clinical Trial 1) is a European multi-center, randomized, open- label trial. SELECT-1 will evaluate a range of up to four doses of Locteron administered every two weeks in combination with ribavirin. A total of 32 treatment-naive hepatitis C genotype I patients will receive this treatment during the 12 week study.
The study will assess viral response, safety and tolerability of Locteron. Results from this study are expected mid-2007 and will be used to select the optimal dose range to be tested in a subsequent Phase IIb study.
"The start of our lead product in its Phase IIa study is a major milestone for OctoPlus," says Joost Holthuis, CEO of OctoPlus. "We believe that Locteron has the potential to be the future treatment of choice for chronic hepatitis C, with less frequent administration and fewer side effects compared to currrent therapies."
We have recently completed a Phase I clinical study where the safety, pharmacokinetics and pharmacodynamics of Locteron were investigated in healthy volunteers. Results of this Phase I clinical trial showed that a single dose of Locteron was safe and well tolerated. In particular, groups receiving Locteron reported fewer, less severe and shorter lasting flu-like symptoms than those subjects receiving PEG-Intron, a
commonly prescribed pegylated interferon.
The data from this trial indicate that Locteron could be dosed once-every-two-weeks, which is a substantial improvement over currently used pegylated interferons that require weekly injections.
Alfa interferon is a protein used to treat infectious diseases, such as hepatitis C and B, and certain cancers. Worldwide sales for hepatitis C therapeutics in 2005 have been estimated at $4 billion.
About hepatitis C
More than four million people in the United States, and more than 200 million people worldwide, are currently infected with hepatitis C. The standard treatment for patients with chronic hepatitis C is pegylated interferon alfa administered in combination with the anti-viral drug ribavirin. The currently available pegylated alfa interferon products require administration once per week for up to 48 weeks and are associated with substantial side effects, particularly during the period following each administration. Independent market research predicts that modified interferons will continue to be a key component of combination therapy for hepatitis C patients and is expected to be complementary with new agents under development. These sources estimate that total interferon sales for the treatment of hepatitis C will exceed $5 billion by 2014.
About OctoPlus
OctoPlus N.V. is a product-oriented biopharmaceutical company committed to the development of improved pharmaceutical products that are based on its 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 and other drugs.
OctoPlus is also a leading provider of advanced drug formulation and clinical scale manufacturing services to the pharmaceutical and biotechnology industry, with a focus on difficult to formulate active pharmaceutical ingredients in injectable formulations. The earnings and expertise that OctoPlus derives from rendering formulation and manufacturing services help to support its 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.
OctoPlus initiates Locteron Phase II clinical study in chronic hepatitis C http://hugin.info/137076/R/1100540/196461.pdf
For further information, please contact:
Rianne Roukema
Corporate Communications
+31(71)524 4044
SOURCE: OctoPlus N.V.
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