This Day On The Street
Continue to site
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

Study Evaluating Eculizumab (Soliris®) In Preventing Antibody-Mediated Rejection (AMR) In Kidney Transplant Recipients Presented At The European Society For Organ Transplantation (ESOT) Annual Congress

“This study suggests that eculizumab, by inhibiting the activation of terminal complement, could be effective in preventing acute AMR, which is a severe and life-threatening complication in sensitized patients undergoing kidney transplantation,” said Martin Mackay, Ph.D., Executive Vice President and Global Head of R&D at Alexion. “We are encouraged by the data presented today from this deceased-donor study, and also continue to enroll patients in our multi-national living-donor transplant trial in patients at elevated risk of AMR.”

Eculizumab is approved in over 40 countries as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) and in the United States, European Union and other countries for patients with atypical hemolytic uremic syndrome (aHUS). PNH and aHUS are both debilitating and life-threatening ultra-rare disorders caused by chronic, uncontrolled complement activation. Eculizumab is not approved for the prevention of AMR in any country and was used in the reported study on an investigational basis.

About the Study

Nine-week preliminary results were presented from an open-label, single-arm, multicenter Phase 2 trial in which 47 sensitized recipients of kidneys from deceased donors were treated with eculizumab. The mean age of the study participants was 50 years (range: 29-70). 1

The study’s primary efficacy composite endpoint was post-transplantation treatment failure rate at Week 9, defined by biopsy-proven AMR, graft loss, patient death, and/or loss to follow-up. Preliminary results presented today are for the primary endpoint modified with utilization of local laboratory data (the pre-specified primary endpoint uses central lab data). At Week 9, 5 patients (10.6%; 95% confidence interval [CI]: 3.5%, 23.1%) were considered treatment failures, of which 3 (6.4%) had acute AMR. The three most common serious adverse events from Weeks 1 to 11 were complications of the transplanted kidney (12.8%), transplant rejection (8.5%), and acute renal failure (8.5%). One patient (2%) in the study died due to a post-operative myocardial infarction deemed not related to eculizumab. 1

About Acute Antibody-Mediated Rejection (AMR)

Acute antibody-mediated rejection (AMR) is a severe and potentially life-threatening condition that can lead to severe kidney allograft damage resulting in rapid loss of function and possible loss of the transplanted kidney. Patients who are sensitized (have high levels of donor-specific-antibodies or DSAs) are at high risk for developing acute AMR, may have difficulty finding a viable donor organ, and therefore may never become eligible for transplantation. The development of acute AMR is believed to be primarily a result of uncontrolled complement activation caused by DSAs, which in turn frequently results in allograft damage and dysfunction, potential graft loss, and/or shortened graft survival.

2 of 5

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
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
SYM TRADE IT LAST %CHG

Markets

DOW 17,776.91 +93.33 0.53%
S&P 500 2,081.34 +12.58 0.61%
NASDAQ 4,997.4590 +5.5190 0.11%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs