This Day On The Street
Continue to site
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

Insmed Announces First Patient Dosed In Pivotal European Phase 3 Clinical Study Of ARIKACE® In Cystic Fibrosis Patients With Pseudomonas Lung Infections

MONMOUTH JUNCTION, N.J., April 16, 2012 /PRNewswire/ -- Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, today announced the initiation of the Company's CLinical Evaluation of ARIKACE phase 3 study (CLEAR-108) of ARIKACE® (liposomal amikacin for inhalation) in Europe for Cystic Fibrosis (CF) patients with Pseudomonas aeruginosa (Pa) lung infections.

"The initiation of this clinical trial represents an important milestone for Insmed as we advance our ARIKACE program," said Timothy Whitten, President and CEO of Insmed.  "Even with currently available treatments, chronic Pa lung infections remain a significant medical issue for CF patients, and we believe ARIKACE has the potential to be an important treatment option for these patients.  In our randomized, placebo controlled phase 2 clinical study, ARIKACE demonstrated statistically significant improvement in lung function over the course of one complete 28-day on-treatment and 28-day off-treatment cycle in CF patients with Pa lung infections.  Our goal is to confirm the benefits of ARIKACE in this phase 3 trial."

CLEAR-108 is a randomized, phase 3 trial comparing ARIKACE 560 mg, delivered once daily via an optimized, investigational eFlow® Nebulizer System (PARI Pharma GmbH), to TOBI®(1) (inhaled tobramycin solution), which is a commercially available inhaled antibiotic that is delivered twice daily.  The Company anticipates that the study will be conducted in approximately 300 patients.  The primary endpoint will be change in pulmonary function (FEV-1) measured after three 28 day on-treatment and three 28 day off-treatment cycles (about six months).  A key secondary endpoint will be time to pulmonary exacerbation. 

The study design was previously agreed upon by Insmed and the European Medicines Agency. Eligible patients will have the option to participate in a longer term open-label safety study, called CLEAR-110.  The study's Principal Investigator is Diana Bilton, M.D., Director of Adult CF Centre at the Royal Brompton Hospital in London, England. 

Top-line data from CLEAR-108 are currently expected to be available in the second half of 2013.

1 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

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
Stocks Under $10

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

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
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AAPL $93.59 -1.30%
FB $117.39 0.57%
GOOG $696.12 0.74%
TSLA $246.16 -0.63%
YHOO $36.44 -0.41%


Chart of I:DJI
DOW 17,717.38 -113.38 -0.64%
S&P 500 2,064.74 -11.07 -0.53%
NASDAQ 4,780.88 -24.4110 -0.51%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs