Curis Announces Nature Publication Elucidating a Paracrine Mechanism of Action in...

Curis Announces Nature Publication Elucidating a Paracrine Mechanism of Action in Hedgehog-Expressing Tumors

CAMBRIDGE, Mass.--(Business Wire)--
Curis, Inc. (NASDAQ: CRIS), a drug development company focused on
developing next generation proprietary targeted medicines for cancer
treatment, today announced the publication of preclinical data in
Nature that support the premise that Hedgehog proteins play an
important role in supporting tumor growth in Hedgehog-expressing solid
tumors through a paracrine mechanism of action.

The paper reported that analysis of human tissue samples by
Genentech scientists revealed that subsets of colorectal, endometrial,
ovarian and pancreatic cancers overexpressed Hedgehog protein. The
paper also included data on preclinical pancreatic and colon cancer
xenograft models demonstrating that administration of a Hedgehog
antagonist results in significant growth delay of the underlying
tumor.

"This paper reports compelling evidence of paracrine signaling and
the tumor growth inhibitory effects of Hedgehog antagonists. These
data suggest that Hedgehog antagonists may have therapeutic value not
just in cancers driven by mutations in the Hedgehog signaling pathway,
such as basal cell carcinomas (BCC), but also potentially in cancers
where Hedgehog signaling is driven by overexpression of the Hedgehog
protein," said Dan Passeri, Curis' President and CEO. "We are
encouraged by our collaborator Genentech's decision to conduct Phase
II trials of GDC-0449 in colorectal and ovarian cancer, in addition to
a study in metastatic and locally advanced BCC. We believe that the
insights provided by these studies into the underlying mechanisms of
Hedgehog's involvement in cancer may lead to more effective treatment
regimens using Hedgehog antagonists such as GDC-0449."

In the paracrine setting, the Hedgehog protein is expressed by the
tumor cells but has its biologic effect upon the surrounding
supporting cells (stromal cells), including effecting these
surrounding cells to support growth of the Hedgehog-secreting tumor
cells. Genentech is currently conducting clinical testing of GDC-0449.
In May 2008, Genentech initiated a Phase II clinical trial in which
approximately 150 patients with colorectal cancer will be treated with
chemotherapy in combination with bevacizumab and will be randomized to
receive GDC-0449 or placebo. In addition, Genentech has indicated that
it expects to initiate Phase II testing of GDC-0449 in advanced
ovarian cancer during the second half of 2008.

Phase I investigators have presented encouraging efficacy and
safety data on the treatment of advanced basal cell carcinoma patients
with GDC-0449 during the American Association for Cancer Research
(AACR) Annual Meeting in April 2008 (Abstract #LB-138) and the
American Society of Clinical Oncology (ASCO) Annual Meeting in June
2008 (Abstract #3516). The data presented at AACR included the
achievement of clinical benefit (clinical or radiological responses or
prolonged stable disease) in 8 of 9 patients treated with GDC-0449. No
dose-limiting adverse events occurred. Two cases of reversible
drug-related Grade 3 hyponatremia (lowered serum sodium level) and one
case of reversible Grade 3 drug-related fatigue were the only grade 3
events reported as of the data cutoff date of April 1, 2008. Genentech
has indicated that it expects to initiate a Phase II advanced basal
cell carcinoma clinical trial during the second half of 2008.

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
the potential therapeutic benefits of drugs that are based upon
Hedgehog antagonists; the expected benefits of insights provided by
Hedgehog studies described in Nature , and Genentech's stated
timelines for the planned development of drug candidates under the
parties' Hedgehog antagonist collaboration. The Company may use words
such as "believes", "expects", "anticipates", "plans", "seeks",
"estimates", "will", "may" or similar expressions to identify these
forward-looking statements. There are important factors that may cause
actual results to be materially different from those indicated by such
forward-looking statements including, among other things, risks
relating to: the potential for adverse results, delays and/or failures
in the Company's targeted cancer drug development program, including
without limitation unplanned delays and/or failures in its clinical
trial of CUDC-101 and its ongoing preclinical studies of CUDC-305; the
success of the Company's collaboration with Genentech, including the
risks that Genentech may experience adverse results, delays and/or
failures in the Hedgehog pathway antagonist program currently under
clinical development and that the Company may have no control over, or
foreknowledge of, the progress of this program; difficulties or delays
in obtaining or maintaining required regulatory approvals for products
under development both internally and through the Genentech
collaboration; the Company's ability to obtain or maintain necessary
intellectual property protection; adverse changes in the Company's
ability to successfully execute its business plan, including the
Company's ability to obtain the substantial additional funding
required for such execution; 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; risks relating to the Company's ability
to enter into and maintain planned collaborations and maintain its
current collaborations with Genentech; and 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
Company's 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