Curis Provides Update on Genentech’s Phase II Clinical Trial of GDC-0449 in Advanced Ovarian Cancer Patients

CAMBRIDGE, Mass.--(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 that it has received preliminary results from a Phase II clinical trial of GDC-0449 from Roche and Genentech, Curis’ collaborator and a member of the Roche Group. GDC-0449, a first-in-class Hedgehog pathway inhibitor, was tested by Roche and Genentech as a single agent maintenance therapy for ovarian cancer patients in their second or third complete remission from the disease. Roche has informed Curis that preliminary findings from the primary analysis of the study warrant additional investigation to clarify and interpret potential clinical activity of the drug candidate observed in this trial. Accordingly, Roche and Genentech have indicated that they plan to further analyze the data, including subset analyses in the coming months. Following these analyses, they expect to make a portfolio decision regarding whether, or to what extent, they will continue development of GDC-0449 in advanced ovarian cancer.

No obvious new safety signals were observed in patients treated with GDC-0449. It is expected that data from this Phase II study will be submitted for presentation at an upcoming medical meeting.

“While we await the final analysis of the data from this advanced ovarian cancer study, we remain optimistic about the continued evaluation of GDC-0449 in tumors such as basal cell carcinoma,” said Dan Passeri, Curis’ President and Chief Executive Officer. “Genentech and Roche have completed enrollment in a pivotal Phase II trial in advanced basal cell carcinoma, a use for which proof of concept has already been demonstrated in a Phase I clinical study. In addition, 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 which we believe, assuming positive data, could expand the commercial opportunity of GDC-0449 in basal cell carcinoma.”

Mr. Passeri added, “We are also optimistic that the breadth of additional clinical studies of GDC-0449 that are being conducted by the National Cancer Institute (NCI) under a collaborative relationship with Genentech, including studies in Hedgehog mutation-based mechanisms-of-action cancers such as medulloblastoma and basal cell nevus (Gorlin) syndrome as well as in tumors that are believed to utilize the Hedgehog pathway in other ways to support their growth including pancreatic, small cell lung, breast, stomach and esophageal cancers and in glioblastoma and sarcoma. We are hopeful that data from these planned and ongoing studies will provide important information that may help to guide future GDC-0449 development decisions.”

Genentech initiated the advanced ovarian cancer trial in December 2008 and completed enrollment in the fourth quarter of 2009. Genentech designed this Phase II clinical trial to investigate whether GDC-0449 might help to delay and/or attenuate tumor re-growth in a maintenance setting following clinical remission of cancer after second-line chemotherapy treatment for recurrent disease. GDC-0449 was evaluated in this study as a single agent maintenance therapy tested in 104 patients with ovarian cancer in second or third complete remission in a randomized, placebo-controlled, double-blind, multi-center Phase II clinical trial. Patients were randomized in a 1:1 ratio to receive either a 150 mg daily dose of GDC-0449 or placebo and were stratified based on whether their cancer was in a second or third complete remission. The primary endpoint of the trial was progression-free survival. Secondary outcome measures included overall survival, measurement of Hedgehog ligand expression in archival tissue and number and attribution of adverse events.

In addition to this Phase II ovarian study evaluating GDC-0449, Genentech and Roche have completed enrollment in a pivotal Phase II trial in advanced basal cell carcinoma. 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, assuming positive results, that it could also submit regulatory approval applications 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 tumorigenic properties.

About the Curis-Genentech Collaboration

Under the ongoing collaboration agreement between Genentech, a 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 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 assuming successful achievement of specified clinical development and regulatory approval milestones, and is also eligible to receive royalties assuming successful commercialization of GDC-0449 by Genentech and its sublicensees, which include Roche and Chugai.

In addition to this ovarian cancer study, GDC-0449 is currently being developed by Genentech and Roche in a pivotal trial in advanced basal cell carcinoma and Genentech and Roche have indicated that they also plan to initiate a Phase II clinical trial in operable basal cell carcinoma during the second half of 2010. Through a collaborative relationship with the 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 potential benefits of GDC-0449 for treating various cancer conditions, and Genentech’s and Roche’s plans and estimates regarding the continued analysis of the ovarian cancer trial data and the advancement of development programs under the collaboration with Curis. Forward-looking statements used in this press release may contain the words "believes", "expects", "anticipates", "plans", "seeks", "estimates”, “assumes”, "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 and Roche 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.
  • Genentech may conclude that the data from the ovarian cancer trial, when available, does not support further allocation of resources to this program;
  • 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 planned.
  • 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 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 otherwise.



CONTACT:

Curis, Inc.
Michael P. Gray, 617-503-6632
Chief Financial and Chief Operating Officer
[email protected]

KEYWORDS:   United States  North America  Massachusetts

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