Human Genome Sciences (HGS) and Aegera Therapeutics (Aegera) have reported that HGS has initiated dosing in a Phase 1 clinical trial to evaluate the safety and tolerability of its lead IAP inhibitor, HGS1029, as monotherapy in patients with advanced lymphoid tumors.
Reportedly, 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.
In addition, the 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 three consecutive weeks followed by a week off.
Gilles Gallant, vice president of clinical research, Oncology at HGS, said: “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. An additional Phase 1 clinical trial is currently ongoing to evaluate the safety and tolerability of HGS1029 in patients with advanced solid tumors.”
Michael Berendt, president and CEO of Aegera, said: “Our collaboration with Human Genome Sciences is progressing very well. 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.”
HGS had acquired exclusive worldwide rights (excluding Japan) to develop and commercialise HGS1029 and other IAP inhibitors from Aegera in December 2007. Preclinical studies have shown that HGS1029 has anti-tumor activity alone and in combination with other anti-cancer agents, including the HGS Trail receptor antibodies, against a number of cancer types.