This Day On The Street
Continue to site right-arrow
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!

Grifols Publishes Positive Phase I Safety Results For Plasmin, A Novel, Direct-Acting Thrombolytic, In The Journal Of Thrombosis And Haemostasis

RESEARCH TRIANGLE PARK, N.C., June 11, 2012 /PRNewswire/ -- Grifols, a global healthcare company based in Barcelona, Spain, today announced publication of phase 1 study results demonstrating good safety and tolerability for the investigational therapy plasmin in treating patients with blood clots in the lower extremities, known as acute peripheral arterial occlusion (aPAO). These clots can block blood flow and thus result in nerve damage, limb amputation or potentially loss of life if not treated promptly.

(Logo: )

Results of the multi-center study are published in the June issue of the Journal of Thrombosis and Haemostasis.

In the study, 83 subjects received Grifols' plasmin, a stabilized protein derived from human plasma, to treat patients with recent-onset, arterial occlusions in native arteries or bypass grafts. The subjects were enrolled in seven sequential dose cohorts that received between 25- 175 mg of plasmin delivered locally via catheter. Seventy-eight subjects completed the study. Subjects were monitored for 30 days for clinical outcomes and laboratory parameters of safety.

Overall, there were no unexpected safety concerns with plasmin treatment. Nineteen patients (23%) had one or more serious adverse events (SAE); major bleeding occurred in four patients (4.8%); and minor bleeding in thirteen patients (15.7%); with no trend toward more SAEs or bleeding episodes at higher doses of plasmin. The data are consistent with prior studies of catheter-delivered thrombolytic drugs for lower extremity arterial or graft occlusion. While the study was not powered for efficacy, the data demonstrated that thrombolysis (>/= 50%) occurred in 79% of subjects receiving 125-175 mg of plasmin compared with 50% who received 25-100 mg.

"The desired clinical outcome is to quickly dissolve the clot while reducing the incidence and severity of bleeding complications that can occur with indirect thrombolytics," said Dr. David Fineberg, Plasmin Medical Director at Grifols. "Our phase 1 results represent an important milestone in the development of plasmin as we continue into phase 2 efficacy trials."

A multi-national phase 2 efficacy trial of Plasmin is currently underway.

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
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!


DOW 18,096.90 -106.47 -0.58%
S&P 500 2,098.53 -9.25 -0.44%
NASDAQ 4,967.1410 -12.76 -0.26%

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