Phase 1 and Preclinical Data Support Further Clinical Study of ARRY-614 in Hematological Cancers
BOULDER, Colo.--(BUSINESS WIRE)--Apr. 19, 2009--
Array BioPharma Inc. (NASDAQ: ARRY) today announced the presentation of
an abstract detailing positive data for its novel, small-molecule p38 /
Tie2 inhibitor, ARRY-614. In this study, ARRY-614 demonstrated the
potential for potent inhibition of cytokine synthesis, including IL-6
and TNF, and anti-tumor activity in hematological cancers. The data was
presented at the American Association for Cancer Research (AACR) 100th
Annual Meeting. The complete poster is available as a PDF on Array's
website at www.arraybiopharma.com.
“The p38 MAP kinase is a modulator of apoptosis and survival pathways as
well as an important regulator of cytokine production,” said Kevin Koch,
Ph.D., President and Chief Scientific Officer. “Up-regulation of
cytokine levels has been implicated in cancer progression. We believe
p38 inhibitors may have significant anti-tumor effect by inhibiting
these key cytokine signals. ARRY-614 has demonstrated potent inhibition
of cytokines in Phase 1 healthy subject studies. Data presented here
supports the use of ARRY-614 for the treatment of cytokine-dependent,
hematological malignancies, including myelodysplastic syndromes (MDS)
and multiple myeloma, with an additional opportunity in certain
cytokine-dependent solid tumor indications.”
Abstract # 331 (April 19, 8:00 a.m.; Hall B-F, Poster Section
12): “Activity of ARRY-614, an inhibitor of p38 map kinase and
angiogenic targets, in hematologic malignancies” details the
inhibitory activity of ARRY-614 against p38 MAPK and Tie2/Tek receptor
tyrosine kinase in relevant preclinical models at well-tolerated
doses. ARRY-614 demonstrated activity both as a single agent and in
combination with Revlimid® (lenalidomide).
Results show that ARRY-614 was well-tolerated and effective in
inhibiting cytokines, including IL-6 and TNF, which play a role in the
regulation of growth and survival in a number of cancers, particularly
hematological cancers. As a single agent, ARRY-614 effectively inhibited
angiogenesis in vivo and inhibited tumor growth in preclinical
models of multiple myeloma. Additionally, data show that administering
p38 inhibitors in combination with lenalidomide yielded superior
inhibition of proinflammatory cytokines and combining ARRY-614 with
standard-of-care agents, lenalidomide and Decadron® (dexamethasone) in
multiple myeloma provided additional anti-tumor effects.
About p38 and ARRY-614
p38 is a key regulator of the tumor microenvironment, regulating both
cytokine production and signaling, as well as modulating apoptosis and
survival pathways. In a number of cancers, including hematological
malignancies, cytokines regulate growth and survival and it is thought
that p38 inhibitors may have an anti-tumor effect in these indications
by inhibiting key cytokine signals. MDS is considered a disease of
inappropriate apoptosis where cytokines, such as TNF, induce apoptosis
in hematopoietic progenitor cells. Therefore, p38 is a high-value target
because of its role in both cytokine production and the apoptotic
process. MDS is an excellent disease for p38 inhibitor proof-of-concept
studies because there are two distinct biological points at which p38
inhibition may restore hematopoiesis. In multiple myeloma, IL-6 plays a
role in survival and proliferation of myeloma clones. Inhibiting IL-6
with a p38 inhibitor may have a direct effect against the myeloma cells
making multiple myeloma and certain cytokine-dependent solid tumors
potential areas for future clinical study with ARRY-614.
ARRY-614 was well tolerated after multiple days of dosing in healthy
subjects and demonstrated a good pharmacokinetic profile supporting
advancement into clinical proof-of-concept studies.
About Myelodysplastic Syndrome (MDS)
Awareness of myelodysplastic syndrome (MDS) has increased in recent
years; according to the study of the Medicare Standard Analytic File (a
random sampling of 5 percent of patients enrolled in Medicare) there are
about 76,000 new cases of MDS each year in the United States, making
this a more prevalent condition than originally assumed. MDS is
considered a disease of apoptotic dysfunction because cytokines are
believed to induce cell death in the progenitor cells that act as
precursors to blood cells. Studies have shown that p38 is involved in
both cytokine production and in the apoptotic process in MDS, so
inhibition of p38 may impact the cause of this disease at two distinct
biological points to restore hematopoiesis.
About Array BioPharma
Array BioPharma Inc. is a biopharmaceutical company focused on the
discovery, development and commercialization of targeted small molecule
drugs to treat patients afflicted with cancer, inflammatory and
metabolic diseases. Our proprietary drug development pipeline includes
clinical candidates that are designed to regulate therapeutically
important target proteins and are aimed at significant unmet medical
needs. In addition, leading pharmaceutical and biotechnology companies
collaborate with Array to discover and develop drug candidates across a
broad range of therapeutic areas. For more information on Array, please
go to www.arraybiopharma.com.
Forward-Looking Statement
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including statements about our future plans for advancing certain of our
proprietary drug programs, the potential to earn future milestone
payments, license fees or royalty revenue and the plans of our
collaborators to further develop drugs we have out-licensed or on which
we are collaborating. These statements involve significant risks and
uncertainties, including those discussed in our annual report filed on
form 10-K for the year ended June 30, 2008, and in other reports filed
by Array with the Securities and Exchange Commission. Because these
statements reflect our current expectations concerning future events,
our actual results could differ materially from those anticipated in
these forward-looking statements as a result of many factors. These
factors include, but are not limited to, our ability to continue to fund
and successfully progress internal research efforts and to create
effective, commercially viable drugs, our ability to achieve and
maintain profitability, the extent to which the pharmaceutical and
biotechnology industries are willing to in-license drug candidates for
their product pipelines and to collaborate with and fund third parties
on their drug discovery activities, our ability to out-license our
proprietary candidates on favorable terms, risks associated with our
dependence on our collaborators for the clinical development and
commercialization of our out-licensed drug candidates, the ability of
our collaborators and of Array to meet objectives tied to milestones and
royalties and our ability to attract and retain experienced scientists
and management. We are providing this information as of April 19, 2009.
We undertake no duty to update any forward-looking statements to reflect
the occurrence of events or circumstances after the date of such
statements or of anticipated or unanticipated events that alter any
assumptions underlying such statements.
Source: Array BioPharma Inc.
Array BioPharma
Tricia Haugeto, 303-386-1193
thaugeto@arraybiopharma.com
or
MacDougall
Biomedical Communications
Cory Tromblee, 781-235-3060
ctromblee@macbiocom.com
