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
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.
For more information, please visit the Aegera website at www.aegera.com
About Human Genome Sciences
The mission of HGS is to apply great science and great medicine to bring
innovative drugs to patients with unmet medical needs. The HGS clinical
development pipeline includes novel drugs to treat lupus, hepatitis C,
inhalation anthrax and cancer.
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 medinfo@hgsi.com
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
This announcement contains forward-looking statements within the meaning
of Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended. The
forward-looking statements are based on Human Genome Sciences’ current
intent, belief and expectations. These statements are not guarantees of
future performance and are subject to certain risks and uncertainties
that are difficult to predict. Actual results may differ materially from
these forward-looking statements because of Human Genome Sciences’
unproven business model, its dependence on new technologies, the
uncertainty and timing of clinical trials, Human Genome Sciences’
ability to develop and commercialize products, its dependence on
collaborators for services and revenue, its substantial indebtedness and
lease obligations, its changing requirements and costs associated with
facilities, intense competition, the uncertainty of patent and
intellectual property protection, Human Genome Sciences’ dependence on
key management and key suppliers, the uncertainty of regulation of
products, the impact of future alliances or transactions and other risks
described in the Company’s filings with the SEC. Existing and
prospective investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of today’s date. Human
Genome Sciences undertakes no obligation to update or revise the
information contained in this announcement whether as a result of new
information, future events or circumstances or otherwise.