OctoPlus' Licensee Biolex Commences Phase IIb Study with Locteron
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OctoPlus N.V. announces that its licensee Biolex Therapeutics has commenced patient dosing in the SELECT-2 Phase IIb clinical study of Locteron®, 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.
In October 2008 OctoPlus entered into an exclusive license and product acquisition agreement with Biolex, worth up to € 100 million. As a result, Biolex holds the full commercial rights to Locteron and is responsible for development and commercialization, and OctoPlus is paid by Biolex to perform process development and to manufacture Locteron.
The Phase IIb study is being conducted in the United States and Europe in 100 treatment-naïve, genotype-1, chronic hepatitis C patients. Patients will be randomized 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 interim results after 12 weeks of treatment are expected to be used as the basis for the selection of the Locteron dose(s) for Phase III studies.
Simon Sturge, CEO of OctoPlus comments: "Having announced earlier this month the seventh company to sign an evaluation contract for OctoPlus' technology, we are now delighted to report this progress in Locteron's clinical development. The start of Biolex's Phase IIb study of Locteron is a major milestone in the commercialization of our proprietary PolyActive technology. We look forward to the results of this large-scale study in hepatitis C patients, which we hope will demonstrate Locteron's potential improved tolerability profile as a result of its controlled release mechanism."
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 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.
In October 2008 OctoPlus entered into an exclusive license and product acquisition agreement with Biolex, worth up to € 100 million. As a result, Biolex holds the full commercial rights to Locteron and is responsible for development and commercialization, and OctoPlus is paid by Biolex to perform process development and to manufacture Locteron.
The Phase IIb study is being conducted in the United States and Europe in 100 treatment-naïve, genotype-1, chronic hepatitis C patients. Patients will be randomized 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 interim results after 12 weeks of treatment are expected to be used as the basis for the selection of the Locteron dose(s) for Phase III studies.
Simon Sturge, CEO of OctoPlus comments: "Having announced earlier this month the seventh company to sign an evaluation contract for OctoPlus' technology, we are now delighted to report this progress in Locteron's clinical development. The start of Biolex's Phase IIb study of Locteron is a major milestone in the commercialization of our proprietary PolyActive technology. We look forward to the results of this large-scale study in hepatitis C patients, which we hope will demonstrate Locteron's potential improved tolerability profile as a result of its controlled release mechanism."
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.
