OctoPlus' Licensee Biolex Completes Patient Enrollment in Phase IIb Study with Locteron
News Jul 03, 2009
OctoPlus N.V. has announced that its licensee Biolex Therapeutics has completed patient enrollment in its SELECT-2 Phase IIb clinical study of Locteron®, a controlled release formulation of interferon alpha for the treatment of chronic hepatitis C. OctoPlus licensed Locteron exclusively to Biolex in October 2008.
- Biolex Therapeutics has completed patient enrollment in the SELECT-2 Phase IIb trial of Locteron.
- Key results from SELECT-2 will be available during the fourth quarter of this year.
- 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.
- Study design
- The Phase IIb study is being conducted in the United States and Europe in over 100 treatment-naïve, genotype-1, chronic hepatitis C patients.
- Patients are 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: "We are very pleased with the clinical progress Biolex has made in the Phase IIb study with Locteron. This swift enrollment will enable the availability of key results from SELECT-2 during the fourth quarter of this year."
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.