Navigation Links
HGS announces results of Phase 2B trial of Albuferon for chronic hepatitis C
Date:11/5/2007

ROCKVILLE, Maryland November 5, 2007 Human Genome Sciences, Inc. (NASDAQ: HGSI) today announced the final results of a Phase 2b clinical trial of the investigational drug, Albuferon (albinterferon alfa-2b), in combination with ribavirin in treatment-naive patients with genotype 1 chronic hepatitis C. This Phase 2b study demonstrated that, with half as many injections as Pegasys (peginterferon alfa 2a), Albuferon was just as effective in achieving sustained virologic response (SVR) an undetectable amount of virus in the blood at 24 weeks following the end of treatment with comparable safety and less impairment of health-related quality of life on treatment. Albuferon is administered every two weeks, while peginterferon alfa-2a requires administration every week.

The final Phase 2b data are being presented this week at the 58 th AASLD Annual Meeting in Boston. In two additional press releases also issued by HGS today, the Company announced the full presentations at AASLD of quality-of-life data from the Phase 2b trial, and results from the Phase 2 trial of Albuferon in combination with ribavirin in patients with chronic hepatitis C who had not responded to previous interferon-based treatment regimens.

The final Phase 2b results suggest that the every-two-week dosing regimen of Albuferon halves the number of injections that are required with peginterferon alfa-2a, while providing at least comparable efficacy, comparable safety and the potential for less impairment of quality of life and daily activity, said Stefan Zeuzem, M.D., Professor of Medicine and Chief, Department of Medicine, J.W. Goethe University Hospital, Frankfurt, Germany. We are continuing the evaluation of the 900-mcg and 1200-mcg doses of Albuferon in larger populations in Phase 3 trials. We also conclude that monthly dosing of Albuferon deserves further evaluation.

In the open-label, multi-center, active-controlled Phase 2b trial, 458 treatment-naive patients with genotype 1 chronic hepatitis C were randomized to four treatment groups: Albuferon 900 mcg every two weeks, Albuferon 1200 mcg every two weeks, Albuferon 1200 mcg every four weeks, and peginterferon alfa-2a 180 mcg once a week. All patients received weight-based oral ribavirin daily. The trial included 48 weeks of treatment, and the primary efficacy endpoint was SVR, defined as undetectable viral load (HCV RNA<10 IU/mL) at 24 weeks following completion of treatment.

Assuming that the Phase 2 results are confirmed in Phase 3, we believe that Albuferon could become the interferon of choice in combination regimens for the treatment of chronic hepatitis C, said David C. Stump, M.D., Executive Vice President, Research and Development, HGS. Both of our Phase 3 trials have completed enrollment ahead of schedule, and we expect to have Phase 3 data available by spring 2009 to support the filing of global marketing authorization applications by fall 2009.

Key Findings from the Phase 2b Study

Albuferon requires half the number of injections as peginterferon alfa-2a, and the final results of the Phase 2b study demonstrated that Albuferon provided at least comparable efficacy and comparable safety vs. peginterferon alfa-2a (ITT analysis), with less impairment of quality of life on treatment and fewer lost days of work .

The final Phase 2b results include the following SVR rates and other findings:

Albuferon 900-mcg Every Two Weeks (Albuferon 900 Q2w)

Based on an intention-to-treat ( ITT) analysis, 58.5% of patients in the Albuferon 900 Q2w treatment group achieved SVR, vs. 57.9% for peginterferon alfa-2a administered every week.

In heavier patients (>75 kg) who were treatment-adherent, 74.2% of those in the Albuferon 900 Q2w treatment group achie ved SVR , versus 53.3% for peginterferon alfa-2a. Among all treatment-adherent patients in the Albuferon 900 Q2w treatment group , 72.3% achieved SVR, versus 66.7% for peginterferon alfa-2a.

Based on the SF-36 Health Survey, patients in the Albuferon 900 Q2w treatment group reported less impairment of health-related quality of life, compared with patients in the peginterferon alfa-2a treatment group, as measured by both physical component and mental component SF-36 summary measures at all time-points throughout the 48-week treatment period.

Significantly fewer working patients in the Albuferon 900 Q2w treatment group reported missing 7 days or more of work during the month prior to their visits at Weeks 12 and 24, vs. the peginterferon alfa-2a group (p<.05; Week 12: 4.2% for Albuferon 900 Q2w vs. 18.1% for peginterferon alfa-2a; Week 24: 5.3% for Albuferon 900 Q2w, vs. 20.3% for peginterferon alfa-2a).

The rate of discontinuations due to adverse events was 9.3% in the Albuferon 900 Q2w treatment group, vs. 6.1% in the peginterferon alfa-2a group. Adverse events observed were those typically expected with interferon therapy.

Albuferon 1200-mcg Every Two Weeks (Albuferon 1200 Q2w)

ITT analysis shows that 55.5% of patients in the Albuferon 1200 Q2w treatment group achieved SVR, vs. 57.9% for peginterferon alfa-2a administered every week.

In heavier patients (>75 kg) who were treatment-adherent, 67.9% of those in the Albuferon 1200 Q2w treatment group achie ved SVR, versus 53.3% for peginterferon alfa-2a every week.

Among all treatment-adherent patients in the Albuferon 1200 Q2w treatment group , 70.6% achieved SVR , versus 66.7% for peginterferon alfa-2a.

ITT analysis shows that the Albuferon 1200 Q2w treatment group exhibited a robust early antiviral response (reduction in hepatitis C RNA viral load to below the level of quantitation): 74.5% for Albuferon 1200 Q2w at Week 12, vs. 65.8% for peginterferon alfa-2a. The Albuferon 1200 Q2w treatment group also had the most rapid time to HCV RNA negativity.

The rate of discontinuations due to adverse events was 18.2% in the Albuferon 1200 Q2w treatment group, vs. 6.1% in the peginterferon alfa-2a group. Adverse events observed were those typically expected with interferon therapy. Dose reductions were attempted in only 24.4% of Albuferon subjects prior to discontinuation, versus 42.9% for peginterferon alfa-2a. Adverse events observed were those typically expected with interferon therapy.

In the Albuferon Phase 3 trials, we are strongly encouraging titration of dose where necessary to increase tolerability, reduce the rate of discontinuations, and maximize the therapeutic benefit of the robust early antiviral response offered by the 1200-microgram dose on a two-week administration schedule, said Dr. Stump.

Albuferon 1200-mcg Monthly (Albuferon 1200 Q4w)

ITT analysis shows that 50.9% of patients in the Albuferon 1200 Q4w treatment group achieved SVR, vs. 57.9% for peginterferon alfa-2a administered every week.

In heavier patients (>75 kg) who were treatment-adherent, 61.0% of those in the Albuferon 1200 Q4w treatment group achie ved SVR, versus 53.3% for peginterferon alfa-2a administered once every week.

Among all treatment-adherent patients in the Albuferon 1200 Q4w treatment group, 62.0% achieved SVR, versus 66.7% for peginterferon alfa-2a.

The rate of discontinuations due to adverse events was 12.1% in the Albuferon 1200 Q4w treatment group, vs. 6.1% in the peginterferon alfa-2a group. Adverse events observed were those typically expected with interferon therapy.

The number of patients experiencing severe hematologic adverse events was significantly lower in the Albuferon 1200 Q4w treatment group (10.3%, vs. 20.2% for peginterferon alfa-2a, p<0.05).

Higher doses of Albuferon administered every four weeks, in combination with ribavirin, will be explored in a separate Phase 2b trial conducted by Novartis, which is expected to begin by year-end 2007.


'/>"/>

Contact: Jerry Parrott
301-315-2777
Edelman Public Relations
Source:Eurekalert

Related medicine news :

1. HHS Announces $75 Million in Supplemental Funding to States for Pandemic Flu Preparedness
2. CRC Health Group Announces Acquisition of Bayside Marin Recovery Center, San Rafael
3. UHW Announces: Antelope Valley Hospital Caregivers and Board Vote to Ratify First Union Contract With SEIU UHW-West
4. HEI, Inc. Announces Sale of RFID Division Assets
5. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
6. Mettler-Toledo International Inc. Announces Webcast of Presentation at Thomas Weisel Partners 2007 Healthcare Conference
7. Z Trim Announces Revocation of Gregory Halpern Severence Agreement
8. Brooke Franchise Corporation Announces Selected July Results
9. Manor Care, Inc. Announces Record Date for Special Stockholder Meeting
10. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Adipex-P(R)
11. Planet Technologies Announces Agreement to Acquire Antigen Laboratories
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... 2016 , ... First Choice Emergency Room , the largest network of ... Medical Director of its new Mesquite-Samuell Farm facility. , “We are pleased to ... said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin Johnson has dedicated ... has implemented orthobiologic procedures as a method for treating his patients. The procedure ... doctors to perform the treatment. Orthobiologics are substances that orthopaedic surgeons use to ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, ... the latter, setting the bar too high can result in disappointment, perhaps even self-loathing. ... toward their goal. , Research from PsychTests.com reveals that behind the ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced ... feelings, many turn to unhealthy avenues, such as drug or alcohol abuse, as a ... has released tools for healthy coping following a traumatic event. , Trauma sufferers tend ...
(Date:6/24/2016)... ... ... a crisis. Her son James, eight, was out of control. Prone to extreme mood shifts ... upset him, he couldn’t control his emotions,” remembers Marcy. “If there was a knife ... and say he was going to kill them. If we were driving on the ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016 Research and ... Market for Companion Diagnostic Tests" report to their offering. ... for Companion Diagnostics The World Market for ... personalized medicine diagnostics. Market analysis in the report includes the ... Market (In Vitro Diagnostic Kits) by Region (N. America, EU, ...
(Date:6/24/2016)... 24, 2016  Arkis BioSciences, a leading innovator ... more durable cerebrospinal fluid treatments, today announced it ... funding is led by Innova Memphis, followed by ... private investors.  Arkis, new financing will accelerate the ... market release of its in-licensed Endexo® technology. ...
(Date:6/23/2016)... , June 23, 2016 ... "Pharmaceutical Excipients Market by Type (Organic Chemical (Sugar, ... Formulation (Oral, Topical, Coating, Parenteral) - Global Forecast to ... The global pharmaceutical excipients market ... at a CAGR of 6.1% in the forecast period ...
Breaking Medicine Technology: