CAMBRIDGE, Mass., Jun 16, 2010 (BUSINESS WIRE) --Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to
develop next generation targeted small molecule drug candidates for
cancer treatment, today announced topline results from a Phase II
clinical trial conducted by Roche and Genentech, Curis' collaborator and
a wholly owned member of the Roche Group, of GDC-0449, a first-in-class
Hedgehog pathway inhibitor. GDC-0449 was tested in combination with
Avastin(R) (bevacizumab) and FOLFOX or FOLFIRI chemotherapy in first-line
metastatic colorectal cancer patients. Roche has informed Curis that the
trial did not meet its primary endpoint of extending the time from
randomization to disease progression or death in study patients who
received GDC-0449 in addition to the current standard of care of
bevacizumab and chemotherapy when compared to those patients that
received only the current standard of care treatment. GDC-0449 is being
developed by Roche and Genentech under a collaboration agreement between
Curis and Genentech. It is expected that data from the Phase II study
will be submitted for presentation at a future medical meeting.
"Despite these disappointing results in metastatic colorectal cancer, we
remain encouraged that Genentech and Roche's clinical development of
GDC-0449 in other cancers continues to make good progress," said Dan
Passeri, Curis' President and Chief Executive Officer. "We continue to
believe that GDC-0449 may offer potential benefit in other cancer
indications because the Hedgehog pathway is thought to act via different
mechanisms of action in other tumor types. For example, proof of concept
has already been shown in advanced basal cell carcinoma, the subject of
a pivotal Phase II clinical trial of GDC-0449 being conducted by Roche
and Genentech. Further, Roche has indicated that it expects to initiate
a Phase II clinical trial in operable basal cell carcinoma patients
during the second half of 2010 and we believe that this may ultimately
greatly expand the commercial opportunity of GDC-0449 in basal cell
carcinoma. Basal cell carcinoma is almost always the result of a
specific mutation in a component of the Hedgehog pathway, an entirely
different mechanism than that of metastatic colon cancer."
Genentech and Roche are also conducting a randomized double-blind
placebo-controlled Phase II trial in advanced ovarian cancer in a
maintenance setting, which is evaluating the ability of GDC-0449 to slow
the time to recurrence of cancer in patients whose disease is in
complete remission, by impeding the residual cancer cells' ability to
grow. Roche has indicated that results from this study are expected
during the second half of 2010.
Mr. Passeri added, "We also were encouraged by interim safety data from
this colorectal cancer study that were presented at this year's ASCO
meeting. The data demonstrated a safety profile that was reasonably
consistent with that of the first-line metastatic colorectal cancer
standard of care treatment of bevacizumab and FOLFOX or FOLFIRI
chemotherapy. We believe that this safety profile may provide
opportunities for either Genentech or the NCI to test GDC-0449 in
combination with chemotherapy and other anticancer agents in other tumor
Genentech initiated the Phase II colorectal cancer study in May 2008 and
completed enrollment in the second quarter of 2009. GDC-0449 was
evaluated in this study in 199 patients with metastatic colorectal
cancer in combination with the current standard of care in a randomized,
placebo-controlled, double-blind Phase II trial. Of the 199 patients
enrolled and randomized in this study, 195 received either a FOLFOX
chemotherapy or FOLFIRI chemotherapy regimen in combination with
bevacizumab every 14 days and were randomized to receive either a 150 mg
daily dose of GDC-0449 or a placebo. A total of 123 patients received
the FOLFOX chemotherapy regimen plus bevacizumab, with 62 of these
patients receiving placebo and 61 receiving GDC-0449. The other 72
patients received the FOLFIRI chemotherapy regimen plus bevacizumab,
with 35 of these patients receiving placebo and 37 receiving GDC-0449.
Four patients did not receive study drug after randomization. The
primary objective of the trial was to measure the period of
progression-free survival from randomization to disease progression or
death. Secondary outcome measures include the measurement of Hedgehog
protein expression in archival tissue and tracking of adverse events.
In addition to this Phase II colorectal study evaluating GDC-0449,
Genentech and Roche have completed enrollment in a pivotal Phase II
trial in advanced basal cell carcinoma (BCC). Results from an earlier
Phase I clinical trial demonstrated a 55% response rate in 33 advanced
BCC patients. GDC-0449 was well tolerated in this Phase I study, with
the most frequent adverse events including muscle spasms, altered taste,
weight loss and hyponatremia. Roche has indicated that it expects data
from the pivotal Phase II study in 2011 and, pending successful results,
that it could also submit regulatory approval submissions in 2011.
About the Hedgehog Pathway
The Hedgehog pathway is normally active during embryonic development and
plays a central role in cell differentiation and proliferation.
Inappropriate activation or dysregulation of the Hedgehog pathway is
believed to play a critical role in the proliferation and survival of
certain cancer cells, including in basal cell carcinoma and
medulloblastoma, as well as in colorectal, ovarian, pancreatic, small
cell lung and breast cancers, among others. The Hedgehog pathway is also
thought to be a potential regulator of cancer stem cells, which are
discrete tumor cell populations that display self-renewal and
About the Curis-Genentech Collaboration
Under the ongoing collaboration agreement between Genentech, a wholly
owned member of the Roche Group, and Curis, GDC-0449 was discovered by
Genentech and was jointly validated through a series of preclinical
studies. Through this collaboration, Genentech and Roche are responsible
for the clinical development, and Genentech (U.S.), Roche (Ex-U.S.
excluding Japan) and Chugai Pharmaceuticals (Japan) are responsible for
commercialization, of GDC-0449. Curis is eligible to receive cash
payments upon the successful achievement of specified clinical
development and regulatory approval milestones, as well as royalties
upon commercialization of GDC-0449 by Genentech and its sublicensees,
which include Roche and Chugai.
In addition to this colorectal cancer study, GDC-0449 is currently being
developed in two additional Phase II clinical trials by Genentech and
Roche, including a pivotal trial in advanced basal cell carcinoma and a
Phase II trial in advanced ovarian cancer. Roche has also indicated that
it expects to initiate a Phase II clinical trial in operable basal cell
carcinoma patients during the second half of 2010. Through a
collaborative research and development agreement (CRADA) with the
National Cancer Institute (NCI), the molecule is also being tested in
several additional NCI-sponsored trials. Details for all GDC-0449
clinical trials are available at ClinicalTrials.gov.
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. Curis is building
upon its previous experiences in targeting signaling pathways, including
in the Hedgehog pathway, in its effort to develop proprietary targeted
cancer programs. For more information, visit Curis' website at www.curis.com.
Curis 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 the expected benefits of GDC-0449 for treating various cancer
conditions and Genentech's estimates regarding the advancement of its
development programs under the collaboration. 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 the actual results to be
materially different from those indicated by such forward-looking
statements including, among other things:
- Genentech and Roche may experience adverse results, delays and/or
failures in their development program under collaboration with Curis.
For example, Genentech may not be able to replicate in later trials
any favorable safety and efficacy data from earlier trials of
GDC-0449, or may otherwise fail to meet applicable regulatory
standards for approval of GDC-0449.
- Curis' collaborator Debiopharm may experience adverse results,
delays and/or failures in its development program under collaboration
with Curis. For example, Debiopharm may not be able to successfully
advance Debio 0932 through its ongoing Phase I clinical trial as
- Curis may experience adverse results, delays and/or failures in its
internal drug development programs, including with respect to its
Phase I clinical trial of CUDC-101, and with respect to its ongoing
preclinical studies of its other targeted cancer programs.
- Curis may experience difficulties or delays in obtaining or
maintaining required regulatory approvals for products under
development both internally and through its collaborations.
- Curis may not be able to obtain or maintain the intellectual
property protection necessary for the development and
commercialization of drug candidates based on its technologies.
- Curis may not be able to obtain the substantial additional funding
required to conduct research and development of its drug candidates.
- Curis may experience unplanned cash requirements, and may not
receive additional anticipated payments under its collaborations, any
of which could shorten the estimated period in which Curis will have
cash to fund its operations and which could also adversely affect
Curis' estimated operating expenses for 2010 and beyond.
- Curis faces risks relating to its ability to enter into and
maintain planned collaborations for development candidates under its
targeted cancer programs, its ability to maintain its current
collaborations with Genentech/Roche and Debiopharm, and the risk that
any such collaborators will not perform adequately or may terminate
such collaborations on short notice and/or for circumstances outside
of our control.
- Curis also faces other risk factors identified in its Quarterly
Report on Form 10-Q for the quarter ended March 31, 2010 and other
filings that it periodically makes with the Securities and Exchange
In addition, any forward-looking statements represent the views only
as of today and should not be relied upon as representing Curis' 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
SOURCE: Curis, Inc.
Michael P. Gray, 617-503-6632
Chief Financial and Chief Operating Officer