Curis Announces Preclinical Efficacy Data for CUDC-305 at EORTC-NCI-AACR Symposium
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- CUDC-305 demonstrates efficacy in solid tumor and hematological
preclinical cancer models -
CAMBRIDGE, Mass.--(Business Wire)--
Curis, Inc. (NASDAQ: CRIS), a drug development company focused on
seeking to develop the next generation of targeted small molecule drug
candidates for cancer treatment, today announced that the Company
presented a poster entitled, "CUDC-305, a novel, synthetic Hsp90
inhibitor with unique pharmacological properties" at the 20th European
Organization for Research and Treatment of Cancer (EORTC)- National
Cancer Institute (NCI)-American Association for Cancer Research (AACR)
Symposium on "Molecular Targets and Cancer Therapeutics" in Geneva,
Switzerland.
"We are pleased to report the progress of our proprietary Hsp90
inhibitor, CUDC-305, as we continue to advance it towards the clinic,"
said Curis President and CEO Dan Passeri. "The compound was designed
to optimize or improve pharmacological properties that we believe
collectively make this a strong drug candidate and potentially a
best-in-class therapeutic. The preclinical data demonstrates efficacy
in both solid tumors and hematological cancers with a potential niche
in the area of brain cancer. We look forward to continuing to provide
updates on this novel compound."
The poster highlighted data demonstrating that CUDC-305 appears to
have a strong combination of pharmacological properties that may
contribute to its potent efficacy in preclinical cancer models. In
preclinical xenograft mouse models, the orally administered compound
exhibited high oral bioavailability and a prolonged terminal half-life
of 20.5 hours in tumors. In addition, brain pharmacokinetic data
demonstrates that CUDC-305 is highly brain penetrable suggesting that
the compound may have potential advantages for the treatment of
primary or metastatic brain cancers.
In a mouse xenograft model for brain cancer wherein tumor cells
derived from a human glioblastoma were implanted subcutaneously,
CUDC-305 exhibited dose-dependent inhibition of tumor growth. The
poster included pharmacodynamic data following this efficacy study
demonstrating upregulation of Hsp70 expression, a biomarker of Hsp90
inhibitor activity, and downreglation of cancer biomarkers including
cMET, cyclin D1 and RAF-1 protein levels in addition to AKT signaling.
Tumors were also collected for immunohistochemisty analysis revealing
a dose-dependent reduction of cell proliferation and micro-vessel
density, which is indicative of an anti-angiogenesis effect.
Furthermore, in a separate mouse xenograft study in which glioblastoma
tumor cells were implanted intracranially, CUDC-305 treatment
significantly prolonged survival in treated mice.
The poster also provided data demonstrating potent in vitro
anti-proliferative activity across a diverse range of preclinical
cancer cell lines representing both solid tumor and hematological
malignancies using dosages well below concentrations effective in
mouse xenograft models. In a hematological mouse xenograft model,
CUDC-305 demonstrated the ability to induce complete tumor regression
following a three week dosing regimen while maintaining a favorable
safety profile.
The Company anticipates filing an IND application for CUDC-305 in
mid-2009 and is currently involved in discussions with several
pharmaceutical companies for a potential collaboration for the
continued development of this compound.
About Hsp90
Hsp90 is a member of a class of proteins called molecular
chaperones that play a fundamental role in the folding, stabilization
and degradation of other cellular proteins, or clients, under normal
or stressful conditions. Hsp90, in particular, has become an
attractive therapeutic target for the treatment of cancer because a
majority of its client proteins are involved in cellular signaling
transduction and have been identified as potential contributors to
various aspects of cancer cell growth and survival. Inhibitors of
Hsp90 activity may be of therapeutic value if they can prevent Hsp90
proteins from protecting the particular client proteins involved in
cancer and allow them to be degraded, thereby inducing cancer cell
death.
About Curis, Inc.
Curis is a drug development company that is committed to
leveraging its innovative signaling pathway drug technologies to seek
to create new targeted small molecule drug candidates for cancer. In
expanding its drug development efforts in the field of cancer through
its targeted cancer drug development platform, Curis is building upon
its previous experiences in targeting signaling pathways for the
development of next generation targeted cancer therapies. For more
information, visit Curis' website at www.curis.com.
Cautionary Statement: This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, including without limitation: statements regarding
Curis' beliefs about the potential efficacy, potency and
pharmacological features of CUDC-305, Curis' belief that CUDC-305 has
the potential to be of superior therapeutic benefit among Hsp90
inhibitors, Curis' belief that CUDC-305 may have therapeutic benefit
for solid tumor and hematological indications including brain cancer,
Curis' plans to enter into a collaboration for the development of
CUDC-305, Curis' expectation that it will file an IND application with
FDA in mid-2009 and Curis expectations regarding the potential
benefits of its targeted cancer drug development programs.
Forward-looking statements used in this press release may contain the
words "believes", "expects", "anticipates", "plans", "seeks",
"estimates", "will", "may" or similar expressions. These
forward-looking statements are not guarantees of future performance
and involve risks, uncertainties, assumptions and other important
factors that may cause actual results to be materially different from
those indicated by such forward-looking statements including, among
other things:
-- The Company may experience adverse results, delays and/or
failures in its internal product development programs,
including without limitation unplanned delays and/or failures
in its ability to further advance its product candidates,
CUDC-101 and CUDC-305, and any other programs under its
targeted cancer drug development platform. For example, the
Company faces the risk that future clinical trials and any
further preclinical testing of such development candidates
will not demonstrate the results shown to date.
-- The Company's collaborator, Genentech, may experience adverse
results, delays and/or failures in the Hedgehog pathway
antagonist program currently under clinical development and
the Company may have no control over, or foreknowledge of, the
progress of this program.
-- The Company may experience difficulties or delays in obtaining
or maintaining required regulatory approvals for products
under development both internally and through its Hedgehog
antagonist collaboration with Genentech.
-- The Company may not be able to obtain or maintain the patent
and other proprietary intellectual property protection
necessary for the development and commercialization of
products based on its technologies.
-- There may be adverse changes in the Company's ability to
execute, its business plan.
-- The Company may not be able to obtain the substantial
additional funding required to conduct research and
development of its product candidates.
-- The Company may experience unplanned cash requirements and
expenditures which, among other things, could shorten the
estimated period in which the Company will have cash to fund
its operations and which could also adversely affect the
Company's estimated operating expenses for 2008 and beyond.
-- The Company faces risks relating to its ability to enter into
and maintain planned collaborations for development candidates
under its targeted cancer drug development programs, its
ability to maintain its current collaborations with Genentech
and the risk that any such collaborators will not perform
adequately.
-- The Company may experience competitive pressures.
The Company also faces other risk factors identified in the
Quarterly Report on Form 10-Q for the quarter ended June 30, 2008 and
other filings that it periodically makes with the Securities and
Exchange Commission. In addition, any forward-looking statements
represent the views only as of today and should not be relied upon as
representing the views as of any subsequent date. Curis disclaims any
intention or obligation to update any of the forward-looking
statements after the date of this press release whether as a result of
new information, future events or otherwise.
Curis, Inc.
Michael P. Gray, 617-503-6632
Chief Financial Officer
mgray@curis.com
Copyright Business Wire 2008
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