-- First-In-Class Investigational Medicine Selectively Inhibits
Hedgehog Signaling Pathway in Patients With Severe Skin Cancer --
LEXINGTON, Mass., Mar 21, 2011 (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 a positive outcome from a pivotal
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, in patients with advanced
basal cell carcinoma (BCC). Genentech informed Curis that the study met
its primary endpoint of achieving a target overall response rate,
showing that GDC-0449 shrank advanced BCC tumors in a pre-defined
percentage of people in the study. A preliminary safety assessment
showed the most common adverse events were consistent with previous
experience with vismodegib. A detailed safety assessment is ongoing.
Roche has indicated that it anticipates making at least one regulatory
submission in 2011 to seek approval to commercialize GDC-0449.
Genentech plans to submit the data from the clinical trial for
presentation at a future medical meeting.
Roche also informed Curis that GDC-0449 (also known as RG3616) now has a
generic name approved by the World Health Organization, vismodegib
"We are extremely pleased by the highly encouraging outcome of this
study, particularly since there is currently no standard of care for
patients with this serious disease," said Dan Passeri, Curis President
and Chief Executive Officer. "We look forward to Genentech's
presentation of the study data in more detail in the near future, and to
its planned regulatory submissions for vismodegib."
For more information about ongoing studies of vismodegib in BCC,
patients and doctors can contact the Genentech clinical trial call
center at (888) 662-6728 or visit www.clinicaltrials.gov.
About the Pivotal Phase II Trial (ERIVANCE BCC/SHH4476g)
ERIVANCE BCC is an international, single-arm, multi-center, two-cohort,
open-label Phase II study that enrolled 104 patients with advanced BCC,
including metastatic and/or locally advanced BCC, defined as patients
whose lesions are not appropriate for surgery, or for whom surgery would
result in substantial deformity. Study participants received 150 mg
vismodegib once daily until disease progression. The primary endpoint of
the study was overall response rate (tumor shrinkage) as assessed by
independent reviewers. Secondary endpoints of the study included overall
response rate as assessed by study investigators, duration of response,
progression-free survival, overall survival and the safety profile. A
preliminary safety assessment showed the most common adverse events were
muscle spasms, hair loss, altered taste sensation, weight loss, fatigue,
nausea, decreased appetite and diarrhea. Serious adverse events were
observed, including fatal events. The deaths are being further
evaluated, but do not appear to be related to vismodegib.
About Basal Cell Carcinoma
According to the American Cancer Society, BCC is the most common type of
skin cancer and accounts for approximately 80 percent of all diagnosed
skin cancers. The disease is generally considered curable when the
cancer is restricted to a small area of the skin. However, in a small
group of people, if the disease is left untreated or does not respond to
treatment, the cancer may advance further into the skin, bones or other
tissues. In rare cases, BCC may advance or spread to other parts of the
body, at which point the disease can become difficult to treat and
About Vismodegib and the Hedgehog Pathway
Vismodegib is designed to selectively inhibit signaling in the Hedgehog
pathway by targeting a protein called Smoothened. The Hedgehog signaling
pathway plays an important role in regulating proper growth and
development in the early stages of life and becomes less active in
adults. However, mutations in the pathway that reactivate Hedgehog
signaling are seen in several different types of cancer. Abnormal
signaling in the Hedgehog pathway is implicated in the majority of BCC
Genentech is also evaluating vismodegib in a Phase II trial in people
with operable forms of BCC, which opened in October 2010. Additionally,
vismodegib is being evaluated by third-party investigators in a number
of other cancers and in people with BCC who have Gorlin syndrome. Gorlin
syndrome is a condition that affects many areas of the body and
increases the risk of developing BCC. For more information, visit http://www.clinicaltrials.gov.
About the Curis-Genentech Collaboration
Under the ongoing collaboration agreement between Genentech, a wholly
owned member of the Roche Group, and Curis, vismodegib (GDC-0449) was
discovered by Genentech and was jointly validated by the parties through
a series of preclinical studies. Pursuant to this collaboration,
Genentech and Roche are responsible for clinical development, and
Genentech (U.S.), Roche (Ex-U.S. excluding Japan) and Chugai
Pharmaceuticals (Japan) are responsible for commercialization of
vismodegib. Curis is eligible to receive cash payments upon the
successful achievement of specified clinical development and regulatory
approval milestones, as well as royalties upon successful
commercialization of vismodegib by Genentech and its sublicensees, which
include Roche and Chugai.
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
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: Genentech and Roche's planned regulatory submissions for
vismodegib; the potential favorable safety and efficacy profile of
vismodegib; and Genentech's plans to present data from the clinical
trial at a future medical meeting. Forward-looking statements used in
this press release may contain the words "believes", "expects",
"anticipates", "plans", "seeks", "estimates", "assumes", "will", "may,"
"could" 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:
- Genentech and Roche may be delayed in making planned regulatory
submissions to seek marketing approval of vismodegib for advanced BCC.
- Genentech and Roche may not demonstrate to the satisfaction of the
FDA or any comparable foreign regulatory agency the safety and
efficacy of vismodegib in the treatment of advanced BCC or any other
- Genentech and Roche may not be able to replicate in later trials
any favorable safety and efficacy data from earlier trials of
vismodegib in other indications, or may otherwise fail to meet
applicable regulatory standards for approval of vismodegib in other
- Even if vismodegib receives marketing authorization, its
benefit/risk profile may not be widely accepted by the medical
community or third party payors for the treatment of advanced BCC.
- Curis or Genentech may not be able to obtain or maintain the
intellectual property protection necessary for the development and
commercialization of vismodegib.
- Genentech has significant discretion in determining the efforts and
resources it will apply to its collaboration with Curis, and has the
right to terminate the collaboration on short notice under specified
circumstances. As such, the timing and amount of cash payments the
Company could receive under the collaboration, and the successful
commercialization of vismodegib, will depend solely on Genentech's and
its sublicensees' efforts and allocation of resources to the
development and commercialization of vismodegib.
- Curis also faces other important risks relating to the successful
development and commercialization of vismodegib, and with respect to
its business, operations, financial condition and future prospects
generally, that are discussed in its Annual Report on Form 10-K for
the year ended December 31, 2010 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 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