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Interferon Controlled Release Delivery System Starts Trial
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OctoPlus Initiates Clinical Trials With Locteron(TM), a Controlled Release Formulation of Alfa Interferon
Press Release Source: OctoPlus
Wednesday November 2, 4:17 am ET
LEIDEN, The Netherlands, November 2 /PRNewswire/ -- OctoPlus, the drug delivery and development company, today announced that it has started dosing the first cohort of subjects in a Phase I clinical trial of Locteron, a 2-weeks controlled release formulation of alfa interferon. The product is specifically designed by OctoPlus with the intention to address key unmet needs in the treatment of its primary indication, chronic hepatitis C infection.
Locteron combines OctoPlus' proprietary PolyActive(TM) drug delivery technology with BLX-883, a recombinant alfa interferon produced by OctoPlus' partner Biolex (Pittsboro, NC, USA) in its patented LEX System(TM). Data from preclinical and clinical studies suggest that BLX-883 is similar to commercially available alfa interferon in many respects. Alfa interferon is a protein used to treat infectious diseases, such as hepatitis B and C, and certain cancers. Worldwide sales for hepatitis C therapeutics currently amount to approximately USD 3 billion.
The Phase I study is a double-blind, randomised, placebo-controlled single-dose escalation study performed in the Netherlands. The trial is designed to evaluate pharmacokinetics, pharmacodynamics, and safety of Locteron in 27 healthy volunteers. In this study, single administrations of three different doses of Locteron will be compared to controls consisting of the delivery vehicle, a placebo, and PEG-Intron (a currently marketed longer-acting pegylated alfa interferon).
About PolyActive
PolyActive is OctoPlus' biodegradable polymeric drug delivery system. Its biodegradability, extensive safety record and linear release properties make PolyActive an excellent technology for the controlled release of proteins and lipophilic small molecules. PolyActive microspheres have been prepared for a number of therapeutic proteins with incorporation efficiencies of up to 100%. The encapsulated pharmaceutical ingredient is released completely and in its active unmodified form. The release characteristics can be tailored to meet specific product requirements.
About Locteron
OctoPlus has designed Locteron with the intention of being a best-in-class therapeutic for patients with chronic hepatitis C. Locteron has the potential to induce less side effects and increase the efficacy and patient compliance. OctoPlus has demonstrated in preclinical studies that formulation with PolyActive enables gradual release of alfa interferon after injection, thus avoiding both high peak and low trough plasma levels. This may prevent the severe side effects induced by current alfa interferon therapeutics. Additionally, Locteron has been designed to be administered once every two weeks, which is more convenient for patients than the pegylated alfa interferon products currently on the market, that need weekly administration. These features may result in an improved clinical profile for Locteron compared to current hepatitis C therapies. Locteron is produced in OctoPlus' cGMP manufacturing facilities in Leiden, the Netherlands.
"There is a clear need for a novel alfa interferon formulation that has less side effects, an improved clinical profile and is more convenient for the patient" commented Dr. Joost Holthuis, CEO of OctoPlus. "PolyActive should enable the development of such a product. Results to date make us very optimistic about Locteron's potential to address these key unmet needs and to contribute significantly to the treatment of hepatitis C infection and other serious diseases".
About OctoPlus
OctoPlus is a product-oriented drug delivery company that focuses on the development of innovative drug delivery systems to build a pipeline of product candidates. OctoPlus is also an internationally established provider of pharmaceutical development services and GMP manufacturing for pharmaceutical and biotechnology companies. The company is located in Leiden, the Netherlands. Please visit the company's website at www.octoplus.nl.
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