"We are pleased with this important decision by Roche to expand the development of Erivedge outside of oncology for the first time, especially in IPF where Hedgehog pathway activation is associated with the disease," said
While the underlying cause of IPF is not well understood, aberrant activation of the Hedgehog signaling pathway has been reported to play a role in the disease. Many developmental pathways, including the Hedgehog signaling pathway, play an essential role during human embryonic development but are generally inactivated later in life. Aberrant activation of these pathways is believed in many cases to lead to pathological events resulting in human disease such as cancer and IPF.
About the Phase 2 IPF Trial
Roche submitted the IND for a Phase 2 randomized, multi-center, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of Erivedge in patients with IPF. Erivedge will be administered orally at a dose of 150 mg daily and the duration of treatment will be 52 weeks. The primary endpoint of the study is mean change in forced vital capacity (FVC) percent predicted from baseline to week 52 in patients with IPF. FVC is a measure of pulmonary function in patients with IPF. The secondary endpoints include change in diffusion capacity of the lung for carbon dioxide (DLCO), annualized rate of change in FVC, progression-free survival, time from randomization to first event of acute IPF exacerbation, change in quality of life measurements and safety. According to Roche, following
About Idiopathic Pulmonary Fibrosis
Idiopathic pulmonary fibrosis (IPF) is a chronic, debilitating lung disease with unknown cause that occurs in adults and has very poor prognosis. The disease is characterized by thickening or scarring of lung tissue (fibrosis) over time, resulting in decreased oxygen supply to the brain and other organs. Currently, there is no cure for IPF and life expectancy for most people is approximately 3 to 5 years after diagnosis. Respiratory failure is the most common cause of death due to IPF. The prevalence of IPF is approximately 1 per 5,000 in men and 1 per 7,700 in women. In
Erivedge is designed to selectively target the Hedgehog signaling pathway, which is implicated in the development of certain types of cancer, including basal cell carcinoma (BCC).
Roche has developed Erivedge under a collaboration agreement with Curis. Erivedge was discovered by
Curis is an oncology-focused biotechnology company developing novel drug candidates for the treatment of human cancers. Curis' pipeline of drug candidates includes CUDC-907, a dual histone deacetylase (HDAC) and phosphoinositide 3-kinase (PI3K) inhibitor, and CUDC-427, a small molecule antagonist of IAP proteins. Curis is also engaged in a collaboration with
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 potential benefits of treating IPF patients with Erivedge, and clinical development plans and timelines for the Phase 2 trial of Erivedge in IPF. 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. For example, Curis and its collaborators may experience adverse results, delays and/or failures in their preclinical and clinical drug development programs. Curis and its collaborators' drug candidates may cause unexpected toxicities and/or fail to demonstrate sufficient safety and efficacy in clinical trials and may never achieve the requisite regulatory approval needed for commercialization. Curis and its collaborators may not achieve projected research, development and commercialization goals in the time frames that they publicly announce. Curis will require substantial additional capital to fund the research and development of its drug development programs. Curis may not obtain or maintain necessary patent protection for its programs and could become involved in expensive and time consuming patent litigation and interference proceedings. Curis and its collaborators face substantial competition. Curis is dependent upon its key collaborators and these collaborations may not be scientifically or commercially successful. Unstable market and economic conditions and other factors may adversely affect Curis' financial condition and its ability to access capital to fund the growth of its business. Curis could lose its rights to Erivedge royalties and related royalty payments if its wholly-owned subsidiary defaults under its secured credit agreement with BioPharma-II. Curis' stock price may not appreciate in value. Curis also faces other important risks relating to its business, operations, financial condition and future prospects that are discussed in its Quarterly Report on Form 10-Q for the quarter ended
In addition, any forward-looking statements represent the views of Curis 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 forward-looking statements after the date of this press release except as may be required by law.
Mani Mohindru, Ph.D. Vice President, Corporate Strategy and Investor Relations Curis, Inc.617-503-6605 firstname.lastname@example.org Michael P. GrayChief Financial and Chief Business Officer Curis, Inc.617-503-6632 email@example.com