Early Data on Amgen's Anti-Angiogenesis Pipeline Molecules Suggest Biologic Activity Across Tumor Types
AMG 386 Preclinical Data Suggests Greater Reduction in Tumor
Growth when Angiopoietin 1/2 and VEGF Pathways are Both Inhibited
Abstract Numbers: 1113, 4887 and 5764
SAN DIEGO--(BUSINESS WIRE)--April 13, 2008--Amgen (NASDAQ:AMGN),
today announced results from preclinical studies suggesting a
significantly greater reduction in tumor growth when AMG 386, a
recombinant Fc-peptide fusion protein (peptibody) designed to bind
angiopoietins 1 and 2, thereby inhibiting Tie2 dependent stimulation
of endothelial cells, was combined with either of two vascular
endothelial growth factor (VEGF) inhibitors -- bevacizumab or
motesanib diphosphate (AMG 706) -- compared with either treatment
alone (p less than 0.05). Angiopoietins, together with VEGFs, are key
cytokines that regulate neovascularization. The results of preclinical
studies that investigated the growth of human colon tumor cells in
this combination were presented at the 2008 American Association for
Cancer Research (AACR) Annual Meeting in San Diego.
"Tumors depend on a reliable blood supply to grow and survive. By
targeting angiogenesis - the process underlying the formation and
growth of new blood vessels - we hope to achieve clinically meaningful
control of many cancers," said Roger M. Perlmutter, Amgen's executive
vice president of Research and Development. "What's encouraging about
these early results is that they indicate that blocking more than one
angiogenesis pathway may offer enhanced potential to inhibit tumor
growth. We look forward to investigating this finding further."
The data were generated from three blinded studies of preclinical
models of colon carcinoma randomized into three experimental groups.
The models were treated with suboptimal doses of motesanib diphosphate
(37.5 - 75 mg/kg QD, PO), bevacizumab (2.8 ug twice per week), AMG 386
(2.8 - 14 ug twice per week) or combinations thereof. In all three
studies, greater reduction in tumor growth was observed when AMG 386
was combined with either motesanib diphosphate or with bevacizumab,
compared to the tumor growth reduction seen with either VEGF inhibitor
alone.
Amgen's Commitment to Angiogenesis Research
Angiogenesis, the process of new blood vessel formation, plays a
critical role in many diseases, including cancer. New blood vessels
constantly form during an embryo's development, but in adults
angiogenesis normally only takes place as part of specific processes
such as recovering from an injury, when the growth of new blood
vessels promotes wound healing. In cancer, tumors grow and metastasize
in part by secreting angiogenic substances, such as VEGF, that can
induce capillary growth into the tumor.
Anti-angiogenesis research is an important area of research for
Amgen. In 2007, Amgen initiated four Phase 2 studies of AMG 386 for
the treatment of renal cell, metastatic breast, ovarian and gastric
cancers.
About Motesanib Diphosphate
Motesanib diphosphate is a highly selective, investigational oral
agent that is being evaluated for its ability to inhibit angiogenesis
and lymphangiogenesis by targeting VEGF 1, 2 and 3. It is also under
investigation for its potential direct anti-tumor activity by
targeting platelet-derived growth factor receptor ("PDGFR") and stem
cell factor receptor ("c-kit") signaling. A Phase 3 study examining
the potential utility of motesanib diphosphate in the treatment of
non-small-cell lung cancer (NSCLC) is currently ongoing, as are Phase
2 studies in patients with metastatic breast cancer or NSCLC comparing
the activity of motesanib diphosphate with that observed using
bevacizumab. In February 2008, Amgen announced the establishment of a
partnership with Takeda supporting the worldwide development and
commercialization of motesanib diphosphate, and the development and
commercialization of up to 13 Phase 2 molecules, including AMG 386, in
Japan. Studies highlighting the in vitro activity of motesanib
diphosphate against imatinib-resistant gastrointestinal stromal tumors
will be presented on Tuesday, April 15 (Abstract no. 4887). The effect
of motesanib diphosphate on radiation responses in preclinical head
and neck cancer models will be presented on Wednesday, April 16
(Abstract no. 5764).
About Amgen
Amgen discovers, develops, manufactures and delivers innovative
human therapeutics. A biotechnology pioneer since 1980, Amgen was one
of the first companies to realize the new science's promise by
bringing safe and effective medicines from lab, to manufacturing
plant, to patient. Amgen therapeutics have changed the practice of
medicine, helping millions of people around the world in the fight
against cancer, kidney disease, rheumatoid arthritis and other serious
illnesses. With a deep and broad pipeline of potential new medicines,
Amgen remains committed to advancing science to dramatically improve
people's lives. To learn more about our pioneering science and our
vital medicines, visit www.amgen.com.
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SOURCE: Amgen