(Plus today HGSI announced that they made a milestone payment to ABGX "triggered by Human Genome Sciences' filing of an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA) for a fully human monoclonal antibody to the CCR5 receptor (CCR5 mAb) created using Abgenix's proprietary XenoMouse® technology. " The CCR5 antibody will be used in HIV.)
>>Albuferon(TM), a novel long-acting form of interferon alpha, was created using Human Genome Sciences' proprietary albumin fusion technology, and is currently in Phase 2 clinical trials for the treatment of chronic hepatitis C.(9-10)
The results of a Phase 1/2 clinical trial of Albuferon in treatment- experienced adults with chronic hepatitis C were presented at the 55th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in November 2004.(11-12) The data, which were presented on 119 patients treated in the study, demonstrate that Albuferon is well tolerated, has a prolonged half-life, and is biologically active and able to reduce viral load with dose- dependent magnitude and durability. Immunogenicity data presented at AASLD show that the vast majority of Albuferon antibody titers were low (<100 ng/mL), consistent with rates reported for pegylated interferons, and that there is no apparent correlation between the emergence of these antibodies and adverse events, antiviral response or pharmacokinetics. Albuferon exhibits a median half-life of 140 hours, supporting dosing at intervals of 2-4 weeks. This compares to a reported mean elimination half-life of 80 hours (50-140 hours) for Pegasys and 40 hours (22-60 hours) for PEG-Intron.(13-14)
In May 2004, Human Genome Sciences began dosing patients in a Phase 2 clinical trial of Albuferon to evaluate its safety, tolerability, pharmacology and optimal dosing in approximately 40 patients with chronic hepatitis C who are naive to interferon-alpha treatments.(10)
In November 2004, the company began dosing patients in a Phase 2 study of Albuferon in combination with ribavirin to evaluate the safety, tolerability and efficacy of Albuferon in up to 100 patients with chronic hepatitis C who have failed to respond to previous interferon alpha-based treatment regimens.(9)
In 2005, Human Genome Sciences plans to complete the ongoing Phase 2 clinical trial in patients who are naove to interferon-alpha treatments, and plans to complete an interim safety analysis of data from the ongoing Phase 2 trial of Albuferon in combination with ribavirin in interferon-experienced patients. The company also plans to initiate and complete the enrollment of a Phase 2b clinical trial of Albuferon in combination with ribavirin in patients who are naive to interferon-alpha treatments.<<
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