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Curis Announces Investigational New Drug Application Filing By Roche To Initiate A Phase 2 Study Of Erivedge(R) (vismodegib) In Idiopathic Pulmonary Fibrosis

Stocks in this article: CRIS

LEXINGTON, Mass., June 23, 2014 (GLOBE NEWSWIRE) -- Curis, Inc. (Nasdaq:CRIS), an oncology-focused biotechnology company developing novel drug candidates for the treatment of human cancers, today announced that Roche has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate a multicenter, Phase 2 clinical study of Erivedge ® (vismodegib) in patients with idiopathic pulmonary fibrosis (IPF), a chronic, debilitating lung disease. Roche and Genentech, a member of the Roche Group, develop and commercialize Erivedge under a collaboration agreement with Curis.

"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 Ali Fattaey, Ph.D., President and Chief Executive Officer of Curis. "IPF represents a serious unmet medical need and patients suffering from this disease are in need of improved treatment options. The IND filing is currently under review by the FDA and we look forward to providing additional details on the study as they become available."  

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 FDA review of the IND, the study is anticipated to start enrollment later this year and is expected to enroll approximately 130 patients. For additional information about the study, please refer to (study identifier: NCT02168530).

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 the United States, the National Heart, Lung and Blood Institute estimates an incidence of approximately 10 to 40 per 10,000 adults.

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