This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
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
Cramer's Action Alerts PLUS - See his portfolio and get alerts BEFORE every trade. Learn more NOW!

Chiesi Reports Successful Completion First-in-Man Phase 1 Study With Novel Inhaled PDE4 Inhibitor

PARMA, Italy, October 16, 2012 /PRNewswire/ --

Chiesi Group announces that it has successfully completed a Phase I trial of its inhaled PDE4 (phosphodiesterase 4) inhibitor, denoted CHF 6001, a new chemical entity developed for the treatment of inflammatory respiratory disorders, such as chronic obstructive pulmonary disease (COPD) and asthma.

     (Logo: http://photos.prnewswire.com/prnh/20121016/568014 )

The phase 1 study was conducted to evaluate safety, tolerability and pharmacokinetics after administration of single doses (up to 2000 µg) and repeated doses (up to 2000 µg for 7 days) to healthy volunteers. CHF6001 was well tolerated up to the highest doses administered, both in single and multiple dose parts of the study, particularly with respect to gastrointestinal side effects: an area which has posed significant development hurdles for other PDE4 inhibitors in the past. No relevant safety findings, including cardiac side effects were observed. The long-lasting exposure in the systemic circulation supports once-a-day dosing. Based on these positive results, two phase 2a proof of concept studies are ongoing in patients with asthma and COPD.

About CHF 6001

CHF 6001 is a novel selective PDE4 inhibitor, optimized for inhaled delivery to improve efficacy and tolerability. The anti-inflammatory activity of CHF 6001 has been proven in vitro and in several animal models of airway inflammation, showing higher potency than the marketed oral PDE4 inhibitor (roflumilast) and more targeted anti-inflammatory effects than corticosteroids in COPD models. The compound is characterized by a low oral bioavailability, inactive metabolites, high plasma protein binding, low plasma/lung concentration ratio and low brain exposure. Moreover, CHF 6001 was very well tolerated in extended pre-clinical safety studies and the safety margin between the anti-inflammatory action and side-effects (such as nausea and emesis) is much larger in comparison to oral and inhaled PDE4 inhibitors developed to date.

The doses achievable in humans with most PDE4 inhibitors are limited by side effects, and therefore the optimal therapeutic effects of this class of drug have never been achieved. The profile of CHF 6001 indicates that it will not be under-dosed in humans to achieve an acceptable side effect profile, supporting its high potential for the treatment of COPD and asthma.

About Chiesi Group

1 of 2

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
Try it NOW
Only $9.95
Try it NOW
14-Days Free
Try it NOW

Check Out Our Best Services for Investors

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
Options Profits

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

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
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!
SYM TRADE IT LAST %CHG

Markets

DOW 17,856.78 -278.94 -1.54%
S&P 500 2,071.26 -29.78 -1.42%
NASDAQ 4,927.37 -55.4390 -1.11%

Partners Compare Online Brokers

Free Reports

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