Human Genome Sciences and Aegera Therapeutics Begin Clinical Trial of Lead IAP Inhibitor HGS1029 in Advanced Lymphoid Tumors

"We are pleased to initiate this first human study of HGS1029 in lymphoid malignancies, and we look forward to continuing the study of our IAP inhibitors both alone and in combination with other anti-cancer agents, including mapatumumab, our agonistic antibody to TRAIL receptor 1," said Gilles Gallant, B. Pharm., Ph.D., Vice President, Clinical Research - Oncology, HGS. An additional Phase 1 clinical trial is currently ongoing to evaluate the safety and tolerability of HGS1029 in patients with advanced solid tumors.

"Our collaboration with Human Genome Sciences is progressing very well," said Michael J. Berendt, Ph.D., President and Chief Executive Officer, Aegera Therapeutics. "We continue to believe that the combination of our extensive knowledge of the control of apoptotic pathways with HGS's deep understanding of the development of targeted therapeutics will speed the development of HGS1029 and follow-on compounds for multiple oncology indications."

According to the group, HGS acquired exclusive worldwide rights (excluding Japan) to develop and commercialize HGS1029 and other IAP inhibitors from Aegera Therapeutics, Inc. in December 2007. When inhibitor-of-apoptosis proteins (IAP's) are over-expressed in cancer cells, they may help cancer cells resist apoptosis, or programmed cell death, and resume growth. The IAP inhibitors developed by Aegera, including HGS1029, are members of a new class of designed small-molecule drugs that block the biological activity of IAP's, thus allowing apoptosis to proceed and causing the cancer cells to die. Preclinical studies have shown that HGS1029 has significant anti-tumor activity alone and in combination with other anti-cancer agents, including the HGS TRAIL receptor antibodies, against a number of cancer types.

About the Phase 1 Trial Design

The primary objectives of the Phase 1 open-label, dose-escalation study are to evaluate the safety and tolerability of HGS1029 as monotherapy in patients with advanced lymphoid tumors, and to select a recommended dose for Phase 2 studies. Secondary objectives include documenting possible anti-tumor activity and determining HGS1029's pharmacokinetic profile. HGS1029 will be administered as a 15-minute intravenous infusion once weekly for 3 consecutive weeks followed by a week off.

Aegera Therapeutics is a clinical stage biotechnology company focused on developing targeted therapeutics to address unmet medical needs.

The mission of HGS is to apply great science and great medicine to bring drugs to patients with unmet medical needs. The HGS clinical development pipeline includes novel drugs to treat lupus, hepatitis C, inhalation anthrax and cancer.

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