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| HUMAN GENOME SCIENCES AND AEGERA THERAPEUTICS ANNOUNCE INITIATION OF CLINICAL TRIAL OF LEAD IAP INHIBITOR HGS1029 IN ADVANCED LYMPHOID TUMORS | |
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- Primary study objectives include evaluation of safety and tolerability, as well as selection of a recommended dose for Phase 2 trials - - Continued progress on IAP inhibitor program - ROCKVILLE, Maryland and MONTREAL, Quebec – November 23, 2009 – Human Genome Sciences, Inc. (Nasdaq: HGSI) and Aegera Therapeutics, Inc. today 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
About Aegera Therapeutics
About Human Genome Sciences
The Company’s primary focus is rapid progress toward the commercialization of its two lead drugs, BENLYSTA™ (belimumab) for lupus and ZALBIN™ (albinterferon alfa-2b) for hepatitis C. Phase 3 development has been completed successfully for both BENLYSTA and ZALBIN. The submission of marketing applications for BENLYSTA is planned in the U.S., Europe and other regions in the first half of 2010. The submission of global marketing applications for ZALBIN is planned in fourth quarter 2009. In April 2009, HGS completed the delivery of 20,000 doses of raxibacumab to the U.S. Strategic National Stockpile for use in the event of an emergency to treat inhalational anthrax. In July 2009, HGS secured a new purchase order for 45,000 doses of raxibacumab to be delivered to the Stockpile over a three-year period beginning near the end of 2009. In May 2009, HGS submitted a Biologics License Application to the FDA for raxibacumab for the treatment of inhalation anthrax. The Company also has several drugs in earlier stages of clinical development for the treatment of cancer, led by the TRAIL receptor antibody mapatumumab and a small-molecule antagonist of inhibitor-of-apoptosis proteins (IAP’s). In addition, HGS has substantial financial rights to certain products in the GSK clinical pipeline including darapladib, currently in Phase 3 development in patients with coronary heart disease, and Syncria® (albiglutide), currently in Phase 3 development in patients with type 2 diabetes. For more information about HGS, please visit the Company’s web site at www.hgsi.com. Health professionals and patients interested in clinical trials of HGS products may inquire via e-mail to This e-mail address is being protected from spam bots, you need JavaScript enabled to view it or by calling HGS at (877) 822-8472. HGS, Human Genome Sciences, BENLYSTA, and ZALBIN are trademarks of Human Genome Sciences, Inc. Safe Harbor Statement
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