Mar 26 2010
Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced interim
results through Week 12 following the end of treatment in a Phase 2b
clinical trial conducted by Novartis to evaluate the safety and efficacy
of ZALBIN™ (albinterferon alfa-2b), an investigational agent,
administered monthly in combination with ribavirin in 391
treatment-naive patients with genotypes 2 and 3 chronic hepatitis C
virus. The primary efficacy endpoint is sustained virologic response
(SVR) at Week 48 (24 weeks following the end of treatment).
“We look forward to the full presentation of
final results from the current study at an appropriate scientific
meeting later in 2010.”
“These interim results may suggest that the efficacy of 1500-mcg
albinterferon alfa-2b dosed every four weeks is comparable to the
current standard of 180-mcg peginterferon alfa-2a dosed once weekly,”
said Stephen Pianko, M.D., F.R.A.C.P., Ph.D., Monash University,
Melbourne, Australia. “The results of this study in patients infected
with genotypes 2 and 3 hepatitis C support continued evaluation of
albinterferon alfa-2b dosed every four weeks in a larger Phase 3
program.”
Sustained virologic response rates at Week 12 (SVR12) following the end
of treatment were 81% for the treatment group receiving 1500-mcg
albinterferon alfa-2b dosed once every four weeks (q4w), vs. 82% for the
treatment group receiving peginterferon alfa-2a (Pegasys) at the
standard 180-mcg dose once every week. SVR12 rates were 76% and 75%,
respectively, for the 900-mcg q4w and 1200-mcg q4w albinterferon alfa-2b
treatment groups.
Overall, the adverse event profile was generally comparable for q4w
albinterferon alfa-2b compared with q1w peginterferon alfa-2a. Serious
adverse events during treatment in the albinterferon alfa-2b treatment
groups were 4% for 900-mcg, 3% for 1200-mcg, and 3% for 1500-mcg,
compared with 4% for peginterferon alfa-2a. Rates of discontinuations
due to adverse events were: 1% for 900-mcg, 3% for 1200-mcg, 4% for
1500-mcg, and 1% for peginterferon alfa-2a. No increase in serious or
severe respiratory events was observed in any albinterferon alfa-2b arm
compared to peginterferon alfa-2a. Hematologic reductions were
significantly lower in all albinterferon alfa-2b treatment groups.
“With a total requirement of six injections over a 24-week course of
treatment, the albinterferon alfa-2b monthly dosing regimen has the
potential to offer an important option for the combination treatment of
patients infected with genotypes 2 and 3 hepatitis C,” said Mani
Subramanian, M.D., Ph.D., Executive Director, Clinical Research -
Infectious Diseases, HGS. “We look forward to the full presentation of
final results from the current study at an appropriate scientific
meeting later in 2010.”
ZALBIN (also known as JOULFERON® outside the U.S.) is being developed by
HGS and Novartis under an exclusive worldwide co-development and
commercialization agreement entered into in 2006. The two companies have
successfully completed Phase 3 development of ZALBIN dosed every two
weeks. HGS has submitted a Biologics License Application (BLA) to the
FDA in the United States for ZALBIN dosed every two weeks and has
received confirmation that its submission was accepted for filing with a
PDUFA target date of October 4, 2010. Novartis has submitted a Marketing
Authorization Application to the European Medicines Agency (EMA) in
Europe for the same dosing regimen under the brand name JOULFERON®.
Source Human Genome Sciences