ArQule, Inc. (Nasdaq: ARQL) today announced that tivantinib and
ARQ 087 will be included in seven presentations during the 2015
Annual Meeting of the American Society of Clinical Oncology (ASCO)
to be held from May 29-June 2, 2015 in Chicago, Illinois.
The presentations with tivantinib (ARQ 197), an oral, selective
inhibitor of the c-MET receptor tyrosine kinase, will feature
clinical trials across multiple diseases and therapeutic
combinations. Data will relate to the safety and combinability of
tivantinib with approved anticancer agents, supporting the ongoing
development of this compound.
The most advanced ongoing clinical trial with tivantinib is a
pivotal Phase 3 randomized, double-blind controlled study (the
METIV-HCC trial) of the compound as single agent therapy in a
biomarker-defined population of previously treated patients with
MET-diagnostic-high, inoperable hepatocellular carcinoma (HCC).
Logistical information for the ASCO presentations featuring
tivantinib follows below.
Abstract #2554A phase I study of ARQ 197 in combination
with temsirolimus in advanced solid tumors.Saturday, May 30, 8:00
AM to 11:30 AMS Hall A, Poster Board: #270CE Kyriakopoulos, MD
Abstract #2549Phase I trial of tivantinib (T) in
combination with carboplatin (C) and pemetrexed (P) as first-line
treatment in patients (pts) with advanced nonsquamous NSCLC or
malignant pleural mesothelioma (MPM).Saturday, May 30, 8:00 AM to
11:30 AMS Hall A, Poster Board #265PA Zucali, MD
Abstract #6060A Randomized Phase II Trial of the MET
inhibitor Tivantinib + Cetuximab Versus Cetuximab alone in Patients
with Recurrent/Metastatic Head and Neck Cancer.Saturday, May 30,
1:15 PM to 4:45 PMS Hall A, Poster Board: #384EE Vokes, MD
Abstract #4065A phase II study of the c-Met inhibitor
tivantinib (tiv) in combination with FOLFOX for the treatment of
patients (pts) with previously untreated metastatic adenocarcinoma
of the distal esophagus, gastroesophageal (GE) junction, or
stomach.Monday June 1, 8:00 AM to 11:30 AMS Hall A, Poster Board
#175S Pant, MD
Abstract #7511ARQ 197 (tivantinib) in patients (pts) with
previously-treated malignant mesothelioma (MM):A phase II trial
from the University of Chicago Phase II Consortium.Monday, June 1,
8:00 AM to 11:30 AMS Hall A, Poster Board #258S Maron, MD
Abstract #4523SWOG 1107: Parallel Randomized Phase II
Evaluation of Tivantinib (ARQ-197) and Tivantinib in Combination
with Erlotinib in Patients (Pts) with Advanced Papillary Renal Cell
Carcinoma (pRCC).Monday June 1, 1:15 PM to 4:45 PMS Hall A, Poster
Board #193P Twardowski, MD
ARQ 087, a multi-kinase inhibitor designed to preferentially
inhibit the fibroblast growth factor receptor (FGFR) family, will
be featured in the following presentation.
Abstract #2545Phase 1, first-in-human study of ARQ 087,
an oral pan-Fibroblast Growth Factor Receptor (FGFR) inhibitor, in
patients (pts) with advanced solid tumors.Saturday May 30, 8:00 AM
to 11:30 AMS Hall A, Poster Board #261K P Papadopoulos, MD
About ArQuleArQule 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
processes 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
tivantinib (ARQ 197) and ARQ 087. 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, tivantinib
and ARQ 087 may not demonstrate promising therapeutic effect; in
addition, they 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 these compounds that could lead the
Company or its partners and collaborators 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 tivantinib is
subject to the ability of the Company as well as Daiichi Sankyo,
Inc., our development partner for tivantinib, and Kyowa Hakko
Kirin, a licensee of tivantinib, 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 for which each of them is responsible. There is a
risk that these issues may not be successfully resolved. In
addition, we and our partners are utilizing a companion diagnostic
to identify MET-high patients in the METIV-HCC and JET-HCC trials,
and 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. Moreover, with respect to partnered programs, even if
certain compounds show initial promise, Daiichi Sankyo or Kyowa
Hakko Kirin may decide not to license or continue to develop them,
as the case may be. In addition, Daiichi Sankyo and Kyowa Hakko
Kirin have certain rights to unilaterally terminate their
agreements with ArQule. If either company were to do so, the
Company might not be able to complete development and
commercialization of the applicable licensed products on its own.
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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version on businesswire.com: http://www.businesswire.com/news/home/20150529005681/en/
ArQule, Inc.Robert J. Weiskopf, 781-994-0300Vice President of
Finance, Corporate Controller and Treasurerwww.ArQule.com
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