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

New Findings Support Less Frequent Dosing In Hemophilia B Patients Treated With Coagulation Factor IX With Recombinant Albumin (rIX-FP)

MELBOURNE, Australia, May 11, 2014 /PRNewswire/ -- Interim Phase II/III and III findings presented today by CSL Behring at the World Federation of Hemophilia (WFH) 2014 Congress demonstrate an improved pharmacokinetic (PK) profile of recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP) among hemophilia B patients of all age groups. These findings suggest an improvement in hemophilia B treatment by allowing a prolonged routine prophylaxis treatment interval of 14 days or potentially longer, compared to the current standard of two to three times per week.  Data were presented during an oral session at the WFH Congress in Melbourne, Australia.  CSL Behring is a subsidiary of CSL Limited (CSL: ASX), a biopharmaceutical company with headquarters in Melbourne, Australia.

"Patients with hemophilia B and treating physicians are eager for innovative products that are able to decrease the dosing frequency while being effective and reliable in the prevention or treatment of bleeding episodes," said Elena Santagostino, MD, Ph.D., and lead investigator of this study.  "Our interim PK data from two Phase III studies, combined with the Phase I and I/II results, demonstrate that rIX-FP has the potential to satisfy this unmet need by offering a longer dosing interval and fewer injections."

"This data provides further encouragement to our ongoing efforts to bring forward to hemophilia patients an improved treatment option that will improve their quality of life," said Charmaine Gittleson, CSL Behring Senior Vice President of Clinical Research and Development. "We look forward to completing this study and moving into the next steps with this promising clinical candidate."

The interim pharmacokinetic results from the two phase III trials were based on the analysis of pharmacokinetic samples over the course of 14 days in 68 severe hemophilia B patients, ages from 1 to 61 years.   A single dose of 50 IU/kg rIX-FP gave a mean FIX activity level above 3% at 14 days in all age ranges.  In a paired comparison, the PK profile of rIX-FP demonstrated a 30 to 40 percent greater incremental recovery and greater than five times longer half-life, along with over five-fold larger area under the curve (AUC) and slower clearance compared with patients' previous plasma-derived and recombinant FIX products.

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 $95.01 0.00%
FB $99.51 -0.24%
GOOG $677.65 -0.75%
TSLA $147.00 -0.67%
YHOO $26.82 -0.85%


Chart of I:DJI
DOW 16,014.38 -12.67 -0.08%
S&P 500 1,852.21 -1.23 -0.07%
NASDAQ 4,268.7630 -14.99 -0.35%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs