Curis Announces Genentech’s Initiation of Phase II Trial for GDC-0449 in Operable Basal Cell Carcinoma

- Genentech Also Determines not to Pursue Phase III Testing of GDC-0449 in Ovarian Cancer Indication -

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 its collaborator Genentech, a member of the Roche Group, has initiated a Phase II clinical trial of GDC-0449, an orally-administered small molecule Hedgehog Pathway Inhibitor, as a single-agent therapy for patients with operable basal cell carcinoma (BCC).

“We are very pleased that Genentech has initiated a Phase II clinical trial in operable BCC as we believe it demonstrates Genentech’s ongoing commitment and diligence in exploring GDC-0449 in BCC,” said Dan Passeri, Curis President and Chief Executive Officer. “In addition, Genentech and Roche continue to work with clinical investigators to evaluate GDC-0449 in other diseases with Hedgehog-pathway mutations such as medulloblastoma, a childhood brain cancer (in studies sponsored by the National Cancer Institute) and in BCCs in basal cell nevus (Gorlin) syndrome, a rare genetic disorder in which patients typically develop multiple BCCs over their lifetime."

In addition to conducting a trial of GDC-0449 in operable BCC, Genentech and Roche are developing GDC-0449 in advanced BCC, a severe form of the disease that includes cutaneous BCCs considered inoperable by the treating physician and BCCs that have metastasized to other tissues and organs. Genentech previously reported compelling proof-of-concept data from a Phase I clinical trial of GDC-0449 in patients suffering from advanced BCC, including the observation of a 55% response rate in 33 advanced BCC patients. In the Phase I study of GDC-0449, the most frequent adverse events included muscle spasms, altered taste, weight loss and hyponatremia. Genentech and Roche have completed enrollment in a 100-patient pivotal Phase II clinical trial of GDC-0449 in advanced BCC, and have indicated that they expect data from this study in the first half of 2011 and, pending successful results, that they could also file regulatory approval submissions in 2011.

Under a collaborative relationship with the NCI, GDC-0449 is also currently being tested in other cancers through several NCI-sponsored trials, including in pancreatic, small cell lung cancer, esophageal, stomach, breast and prostate cancers, among others. Details for all GDC-0449 clinical trials are available at ClinicalTrials.gov.

Genentech has also completed further analyses of results from its recently-completed Phase II clinical trial of GDC-0449 in advanced ovarian cancer. The median time to disease progression in the Phase II study was 7.5 months for patients who received GDC-0449 compared to 5.8 months for patients who received placebo (HR=0.791, p=0.3944). Genentech has concluded that these results did not demonstrate sufficient clinically meaningful improvement in progression-free survival to warrant additional clinical testing of GDC-0449 in ovarian cancer at this time. No obvious new safety signals were observed, and ongoing trials in other tumor types will not be impacted by these results. Further research is needed to determine whether there is a role for GDC-0449 in the treatment of appropriately selected patients with ovarian cancer.

About the Phase II Operable BCC Trial

Genentech and Roche expect to evaluate GDC-0449 in approximately 50 patients with operable nodular BCC in a US-based, open label, two-cohort clinical trial. All patients will receive a 150 mg daily oral dose of GDC-0449 for 12 weeks. The primary outcome measures of the trial are as follows:

  • Cohort 1: The rate of complete histological clearance of the target nodular BCC lesions at the time of tumor excision (which may occur up to 12 weeks following initiation of treatment).
  • Cohort 2: The rate of durable complete clearance of target nodular BCC lesions at the time of excision (which may occur up to 36 weeks following initiation of treatment).

The secondary outcome measure for both cohorts is to determine the time to complete histological clinical clearance of target nodular BCC lesions. Trial details are posted at ClinicalTrials.gov.

About Basal Cell Carcinoma

BCC is the most common form of all cancers. There are approximately 1 million newly diagnosed BCCs in the U.S. and 2.5 million new BCCs worldwide each year, with nodular BCC accounting for an estimated 60% of this total. BCCs arise in the basal cells, which are at the bottom of the epidermis (outer skin layer). The majority of BCC cases are believed to be caused by a mutation in the Hedgehog pathway as a result of chronic exposure to sunlight. BCCs occur most frequently on exposed parts of the body such as the face, ears, neck, scalp, shoulders, and back.

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.

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.

Cautionary Note Regarding Forward-Looking Statements: 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 Company’s expectations regarding the further development and clinical and therapeutic utility of GDC-0449. 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.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 June 30, 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

INDUSTRY KEYWORDS:   Women  Health  Biotechnology  Clinical Trials  Genetics  Oncology  Pharmaceutical  Consumer

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