Human Genome Sciences And Aegera Therapeutics Announce Initiation Of Clinical Trial Of Lead IAP Inhibitor HGS1029 In Advanced Lymphoid Tumors

Main Category: Cancer / Oncology
Also Included In: Clinical Trials / Drug Trials
Article Date: 24 Nov 2009 - 6:00 PDT

email to a friend   printer friendly   opinions  

Human Genome Sciences, Inc. (Nasdaq: HGSI) and Aegera Therapeutics, Inc. announced 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.

"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."

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.

About Aegera Therapeutics

Aegera Therapeutics is a clinical stage biotechnology company focused on developing targeted therapeutics to address major unmet medical needs. In addition to HGS1029 (AEG40826), Aegera has the following programs in clinical development:

AEG35156 is a DNA antisense oligonucleotide that targets the key anti-apoptotic protein XIAP, and is currently in multiple Phase 2 human clinical trials for the treatment of solid tumors and hematological malignancies; and

AEG33773 is a first-in-class oral small molecule HSP90 modulator, which is in Phase 2a development for the treatment of painful diabetic neuropathy in North American and Europe.

Source
Human Genome Sciences

• Additional
• References
• Citations