[April 21, 2015] |
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ArQule Announces Data Presentations with ARQ 087, Inhibitor of FGFR, at AACR
ArQule, Inc. (Nasdaq:ARQL) today announced that data with ARQ 087, a
potent FGFR (Fibroblast Growth Factor Receptor) inhibitor, will be
presented today at the 2015 Annual Meeting of the American Association
for Cancer Research (AACR). ARQ 087 is currently in a Phase 2 trial in
patients with Intrahepatic Cholangiocarcinoma (iCCA) with FGFR2 fusions
and a Phase 1b trial in adrenocortical tumors and tumors with FGFR
translocations, amplification and mutations.
"Important data with ARQ 087 presented at AACR demonstrate the
correlation of circulating FGF levels with clinical benefit in patients,
including tumor responses seen to date in iCCA following single agent
treatment with this compound," said Brian Schwartz, M.D., chief medical
officer of ArQule. "These findings provide additional rationale for the
ongoing clinical development of this compound as a highly targeted
therapeutic option in advanced solid tumors. Additional data from
another presentation underscore the potential broad therapeutic
application of ARQ 087, in combination with other anti-cancer agents."
ARQ 087 Presentations
Abstract Number CT319 Presentation Title: Determination of FGF
19, 21 and 23 protein levels in a phase 1 clinical trial of ARQ 087, an
oral pan-FGFR inhibitor Presentation Time: Tuesday, April 21,
2015, 8:00 AM - 12:00 PM Location: Section 24
Abstract Number 3500 Presentation Title: Combinations of ARQ087
with chemotherapeutic agents are safe and show a striking antitumor
activity in different xenograft models (abstract # 3500; sec 27, board #
23) Presentation Time: Tuesday, April 21, 2015, 8:00 AM - 12:00
PM Location: Section 27
About ArQule
ArQule is a biotechnology company engaged in the research and
development of next-generation, small-molecule cancer therapeutics. The
Company's targeted, broad-spectrum products and research programs are
focused on key biological proesses that are central to human cancers.
ArQule's lead product, in Phase 2 and Phase 3 clinical development, is
tivantinib (ARQ 197), an oral, selective inhibitor of the c-MET receptor
tyrosine kinase. The Company's pipeline includes: ARQ 092, designed to
inhibit the AKT serine/threonine kinase; ARQ 087, a multi-kinase
inhibitor designed to preferentially inhibit the fibroblast growth
factor receptor (FGFR) family; and ARQ 761, a Beta lapachone analog
being evaluated as a promoter of NQ01-mediated programmed cancer cell
necrosis. ArQule's current discovery efforts are focused on the
identification of novel kinase inhibitors, leveraging the Company's
proprietary library of compounds.
This press release contains forward-looking statements regarding the
Company's clinical trials and planned clinical trials with ARQ 087, as
well as its ability to fund operations with current cash and marketable
securities. These statements are based on the Company's current beliefs
and expectations, and are subject to risks and uncertainties that could
cause actual results to differ materially. Positive information
about pre-clinical and early stage clinical trial results does not
ensure that later stage or larger scale clinical trials will be
successful. For example, ARQ 087 may not demonstrate promising
therapeutic effect; in addition, it may not demonstrate appropriate
safety profiles in current or later stage or larger scale clinical
trials as a result of known or as yet unanticipated side effects. The
results achieved in later stage trials may not be sufficient to meet
applicable regulatory standards or to justify further development.
Problems or delays may arise prior to the initiation of planned clinical
trials, during clinical trials or in the course of developing, testing
or manufacturing ARQ 087 that could lead the Company to fail to initiate
or to discontinue development. Even if later stage clinical
trials are successful, unexpected concerns may arise from subsequent
analysis of data or from additional data. Obstacles may arise or issues
may be identified in connection with review of clinical data with
regulatory authorities. Regulatory authorities may disagree with the
Company's view of the data or require additional data or information or
additional studies. In addition, the planned timing of initiation
and completion of clinical trials for ARQ 087 is subject to the ability
of the Company to enroll patients, enter into agreements with clinical
trial sites and investigators, and overcome technical hurdles and other
issues related to the conduct of the trials. There is a risk that these
issues may not be successfully resolved. In addition, we expect
to utilize diagnostic tools in our biomarker-guided clinical trials with
ARQ 087; we may encounter difficulties in developing and obtaining
approval for companion diagnostics, including issues relating to
selectivity/specificity, analytical validation, reproducibility, or
clinical validation. Any delay or failure by our collaborators or
ourselves to develop or obtain regulatory approval of the companion
diagnostics could delay or prevent approval of our product candidates.
Drug development involves a high degree of risk. Only a small number
of research and development programs result in the commercialization of
a product. Positive pre-clinical data may not be supported in
later stages of development. Furthermore, ArQule may not have the
financial or human resources to successfully pursue drug discovery in
the future. For more detailed information on the risks and uncertainties
associated with the Company's drug development and other activities, see
the Company's periodic reports filed with the Securities and Exchange
Commission. The Company does not undertake any obligation to publicly
update any forward-looking statements.
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