HGSI Starts Phase-3 Albuferon Trial in Genotype-2/3 HCV
[The trial itself was previously announced and will test biweekly dosing. (A separate phase-2 trial will test monthly doing.) This is the only trial of a new HCV agent to enter phase-3 for the non-gentotype-1 population. Please see #msg-13781766 for a description of the overall phase-3 program. HGSI is holding its 4Q06 CC at 5pm ET today.]
>> Human Genome Sciences Initiates Phase 3 Clinical Trial of Albuferon(R) With Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C Genotypes 2 and 3
Tuesday February 27, 4:06 pm ET
Enrollment of both Phase 3 trials of Albuferon to be completed in 2007
Global marketing applications planned in 2009
ROCKVILLE, Md., Feb. 27 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. (Nasdaq: HGSI ) today announced that it has initiated dosing in ACHIEVE 2/3, a Phase 3 clinical trial of Albuferon® (albinterferon alfa-2b) in combination with ribavirin in treatment-naive patients with chronic hepatitis C genotypes 2 and 3. ACHIEVE 2/3 is the second of two pivotal Phase 3 trials of Albuferon that HGS is conducting, with the goal of filing global marketing applications in 2009. Albuferon is being developed by HGS and Novartis under an exclusive worldwide development and commercialization agreement entered into in June 2006.
"We believe that Albuferon could become the interferon of choice in treatment regimens for chronic hepatitis C, and we are pleased to announce that both Phase 3 trials of this potentially important compound are now underway," said H. Thomas Watkins, President and Chief Executive Officer, HGS. "These trials, assuming that they are successful, will provide the pivotal data to support global marketing applications for Albuferon in 2009."
…About the Albuferon Phase 3 Development Program
The Albuferon Phase 3 clinical development program includes two randomized, open-label, active-controlled, multi-center, non-inferiority trials to evaluate the efficacy, safety and impact on health-related quality of life of Albuferon in combination with ribavirin, versus PEGASYS (peginterferon alfa-2a) in combination with ribavirin. In December 2006, HGS initiated dosing in ACHIEVE 1, a Phase 3 trial of Albuferon in treatment-naive patients with chronic hepatitis C genotype 1. ACHIEVE 2/3 will be conducted in treatment-naive patients with chronic hepatitis C genotype 2 or 3.
"HGS designed ACHIEVE 1 and ACHIEVE 2/3 working closely with our development and commercialization partner, Novartis, and with leading international experts in the field of hepatitis C," said David C. Stump, M.D., Executive Vice President, Research and Development, HGS. "We also reviewed the pivotal trial designs with U.S. and key European regulatory authorities and received their positive feedback. Based on the response we have had from the clinical research community, we fully expect to attain our goal of completing the enrollment of both of our Phase 3 trials of Albuferon by the end of 2007."
Higher doses of Albuferon administered every 4 weeks, in combination with ribavirin, will be explored in a separate Phase 2b trial to be conducted by Novartis, beginning in 2007.
…Conference Call
HGS management will hold a conference call to discuss this announcement, as well as the Company's fourth quarter and full-year 2006 results, today at 5:00 PM Eastern time. Investors may listen to the call by dialing 800-263-8506 or 719-457-2681, passcode 1549825, five to ten minutes before the start of the call. A replay of the conference call will be available within a few hours after the call ends. Investors may listen to the replay by dialing 888-203-1112 or 719-457-0820, confirmation code 1549825. Today's conference call also will be webcast and can be accessed at http://www.hgsi.com. Investors interested in listening to the live webcast should log on before the conference call begins in order to download any software required. Both the audio replay and the archive of the conference call webcast will remain available for several days. <<
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