good find, thanks.
here is the abstract:
"Background and aims
In a previous single dose clinical trial, Medusa� formulation of human recombinant IFN (IFNa-2bXL) was shown to be safe, with a promising antiviral activity. It reduces peak serum IFN concentrations and provides sustained release of the active IFN, thus having the potential to improve efficacy and tolerability of IFN-a therapy in HCV patients. The present trial aimed to further investigate the antiviral activity of IFNa-2bXL and confirm its safety, as compared with Peg-IFNa-2b.
Methods
A phase Ib, randomized, parallel groups study was conducted in HCV patients allocated to either IFNa-2bXL 18MIU (n=11), IFNa-2bXL 27MIU (n=12), or Peg-IFNa-2b 1.5 �g/Kg (n=14). The effects of two sequential administrations of each treatment, at one week interval, were compared. Viral load kinetics and safety parameters were monitored during the two post-dosing periods, i.e. up to day 14.
Results
IFNa-2bXL 27MIU appeared to have a greater antiviral activity than IFNa-2bXL 18MIU.
The antiviral activity profile of IFNa-2bXL 27MIU was similar to that of Peg-IFN following the first dosing in genotype 1 patients (n=9 in both groups), including patients either non-responder, relapser or naive to previous standard Peg-IFNa-2b therapy.
Following the second injection, IFNa-2bXL 27MIU showed a similar nadir effect on viral load decrease, but resulted in a significantly greater antiviral activity at day 14 than Peg-IFNa-2b (-0.61 vs. -0.21 log, p<0.05).
In non-responder genotype 1 patients, IFNa-2bXL 27MIU (n=6) showed a similar antiviral activity than Peg-IFNa-2b (n=6) during the first dosing period, and a nearly significant superiority at the end of the second dosing period.
Remarkably, IFNa-2bXL 27MIU was associated with a reduced mean number of treatment-related AEs/patient vs. Peg-IFNa-2b (5.2 vs. 7.6 AEs/patient), including less systemic treatment-related AEs (i.e. fever and WBC abnormalities) and a two-fold decrease in injection site reactions. No serious nor severe AEs occurred in any group.
Conclusions
These findings demonstrate clinically significant favorable antiviral activity and safety profile of slow release IFNa-2bXL in HCV patients as compared to referent Peg-IFNa-2b. Such results support the rationale for further developing IFNa-2bXL. A 12-week Phase II evaluation of weekly dosing of IFNa-2bXL in HCV patients is warranted."