Human Genome Begins Trial - Analyst Blog

Recently, Human Genome Sciences, Inc. (HGSI) and Aegera Therapeutics announced the initiation of dosing in a phase I clinical trial to evaluate the safety and tolerability of its lead inhibitor-of-apoptosis protein (IAP), HGS1029, as monotherapy in patients with advanced lymphoid tumors.

An additional phase I clinical trial of the compound is being conducted to evaluate its safety and tolerability in patients with advanced solid tumors. Earlier in December 2007, Human Genome acquired exclusive worldwide rights (excluding Japan) to develop and commercialize HGS1029 and other IAPs from Aegera Therapeutics.

The primary objectives of the phase I open-label, dose-escalation study include the evaluation of safety and tolerability of HGS1029 as monotherapy in patients with advanced lymphoid tumors and selection of a recommended dose for further studies. In addition, secondary objectives include studying possible anti-tumor activity and determining the compound’s pharmacokinetic profile. The drug is to be administered as a 15-minute intravenous infusion once weekly for 3 consecutive weeks followed by a week off.

Although this is good news for the company, the candidate being in the initial stage has a long way to go before commercialization. Hence the company’s prime focus is towards the commercialization of its two lead drugs, Benlysta (belimumab), being developed with GlaxoSmithKline (GSK) for lupus and Zalbin (albinterferon alfa-2b) for hepatitis C. Both the candidates have successfully completed phase III development. While Human Genome plans to submit marketing applications for Benlysta in the US, Europe and other regions in the first half of 2010, the submission of global marketing applications for Zalbin has been planned to be done by the year end.

Earlier this month, Human Genome received a huge boost when Benlysta met its primary endpoint in BLISS-76, a pivotal phase III study, through 52 weeks. This is the second phase III trial in seropositive patients with systemic lupus erythematosus (SLE). Positive results from the first trial, BLISS-52, were announced earlier this year. However, the BLISS-76 study is in progress and will continue for 24 more weeks. Additional data will be available following completion of the full 76-week study period.

Even though we are optimistic about the prospects of Benlysta, which could be a blockbuster on approval, the product is not likely to receive approval before 2011. We maintain a Neutral rating on the stock.
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