Date: 2011-03-31
Type of information:
phase: 2b
Announcement: results
Company: OctoPlus (The Netherlands) Biolex Therapeutics (USA)
Product: Locteron® (controlled-release interferon alpha )
Action mechanism: The product incorporates an advanced controlled-release drug delivery technology that allows dosing once every two weeks.
Disease: hepatitis C genotype 1 virus (HCV)
Therapeutic area: Infectious diseases
Country: USA, Europe
Trial
details: SELECT-2 has been conducted in 116 treatment-naïve, genotype-1, chronic hepatitis C patients. Patients were 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 (1.5 µg/kg, administered every week), with all patients receiving weight-based ribavirin. Patients were treated for 48 weeks and were followed for an additional 24 weeks to determine the SVR rate.
Latest
news: OctoPlus has announced that its licensee Biolex Therapeutics has presented final results from the Locteron® Phase IIb clinical study at the 46th Annual Meeting of the European Association for the Study of the Liver (EASL) in Berlin, Germany. Locteron®’s observed advantages include significant reductions in flu-like symptoms, reduced rates of depression, and a 50% lessfrequent dosing regimen with once every other week dosing. Final SELECT-2 study results include :
- Sustained virologic response (SVR) rates at completion of the trial (week 72), as well as final tolerability comparison results using both traditional clinic visit data and electronic patient reported outcome measures. The SVR for each of the three Locteron® doses studied was comparable with or exceeded the response rate for the PEG-Intron control. 41 % of the patients achieved SVT with 640 µg of Locteron® administered one every two weeks, compared to 34 % with 480 µg of Locteron®, 36% with 320 µg and 33% with PEG-Intron.
- Timing and frequency of depression during the 48 weeks of treatment in SELECT-2. All results reported include all patients who were dosed at least once in the trial. All three doses of Locteron® in SELECT-2 demonstrated viral kinetics and sustained virologic response (SVR) rates that were comparable with or exceeded the PEG-Intron control while also achieving a statistically significant reduction in flu-like adverse events and lower use of concomitant medications. Biolex expects the commercial dose of Locteron to be in the 320 to 480 µg range as the SVR rates for these two doses were comparable with or exceeded the control, and the tolerability advantages (including lower discontinuation rates due to adverse events) were greatest within this dose range.
