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

Proteon Therapeutics Announces Positive Phase 2 Trial Results Of PRT-201 In Chronic Kidney Disease Patients Undergoing Surgical Placement Of An Arteriovenous Fistula For Hemodialysis

WALTHAM, Mass., Jan. 4, 2013 /PRNewswire/ -- Proteon Therapeutics, Inc., a private biopharmaceutical company developing novel, first-in-class pharmaceuticals to address the critical medical needs of patients with kidney and vascular diseases, today announced results from its Phase 2 clinical trial of PRT-201 in chronic kidney disease (CKD) patients undergoing surgical placement of an arteriovenous fistula (AVF) in preparation for hemodialysis. The Phase 2 results demonstrated that treatment with PRT-201 prolonged primary unassisted patency and improved the rate of AVF maturation. Additionally, PRT-201 was well tolerated at the doses tested.

The arteriovenous fistula is the optimal form of vascular access for hemodialysis patients because it is associated with reduced morbidity and lower costs. However, AVFs frequently suffer from neointimal hyperplasia and stenosis formation, resulting in maturation failure and loss of patency.

"AVF patency loss and non-maturation are significant problems, necessitating multiple endovascular (angioplasty) and surgical procedures to restore or maintain blood flow and resulting in prolonged use of dialysis catheters, which have a very high rate of infection. This results in poorer outcomes and significantly increases morbidity and cost," said Dr. Prabir Roy-Chaudhury, Professor of Medicine at the University of Cincinnati, Academic Health Center, Cincinnati, OH. "In this context, the safety and efficacy results of this Phase 2 study are very encouraging and warrant further evaluation of PRT-201 in this patient population."

The randomized, double-blind, placebo-controlled Phase 2 study evaluated the safety and efficacy of PRT-201 delivery immediately following surgical creation of an AVF. A total of 151 patients were randomized to one of two doses of PRT-201, or placebo. The primary endpoint was the duration of unassisted primary patency, defined as the time from surgical creation of the AVF until thrombosis or the occurrence of a procedure to maintain or restore patency (e.g., balloon angioplasty). AVF maturation was a secondary efficacy endpoint.

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
Only $9.95
14-Days Free
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 18,080.14 +21.45 0.12%
S&P 500 2,117.69 +4.76 0.23%
NASDAQ 5,092.0850 +36.0220 0.71%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs