This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
TheStreet Open House

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

Stock quotes 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 www.clinicaltrials.gov (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.

1 of 2

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 16,730.89 -73.82 -0.44%
S&P 500 1,936.94 -9.22 -0.47%
NASDAQ 4,394.1780 -27.9070 -0.63%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs