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

AbbVie Presents Preliminary Results From Phase I Study Of Investigational Oncology Compound ABT-199/GDC-0199 In Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) At European Hematology Association Annual Meeting

NORTH CHICAGO, Ill., June 17, 2013 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced preliminary results from a Phase I study of ABT-199/GDC-0199, an investigational BCL-2 (B-cell lymphoma 2) selective inhibitor, in patients with high-risk relapsed/refractory chronic lymphocytic leukemia (CLL), and in patients with relapsed/refractory non-Hodgkin's lymphoma (NHL). High-risk CLL patients are those with deletions of chromosome 17p or whose disease is refractory to fludarabine therapy. These data were presented at the 18 th Congress of the European Hematology Association (EHA) in Stockholm, Sweden.

This Phase I, open-label, multicenter, international trial was designed to assess the safety, determine the maximum tolerated dose and recommended Phase II dose, and evaluate the pharmacokinetics of ABT-199/GDC-0199 in patients with relapsed/refractory CLL and NHL. Secondary objectives included preliminary efficacy, including objective response rate, duration of response, time to progression, progression-free survival and overall survival. 

"New treatment options are critically needed for patients with hard-to-treat cancers including high risk CLL and MCL," said Gary Gordon, M.D., divisional vice president, oncology clinical development, AbbVie. "The preliminary data presented at EHA further support the ongoing clinical trial program for ABT-199/GDC-0199 via the BCL-2 pathway."

CLL ArmAs of April 2013, 56 patients have enrolled in the CLL arm of the Phase I trial, and 40 patients are currently active. Study participants were given a single oral dose of ABT-199/GDC-0199, followed by six days without medication, before continuous once-daily dosing. Due to concerns over tumor lysis syndrome (TLS), the initial dose was reduced and daily dosing was modified. Single-agent activity was observed in the trial and warrants further single-agent and combination trials evaluating ABT-199/GDC-0199 in patients with CLL. Dose and schedule evaluation will continue.

Of the 56 patients enrolled, 34 were considered high-risk CLL patients – those with deletions of chromosome 17p or whose disease is refractory to fludarabine therapy. In the post-hoc analysis to determine if high-risk CLL patients could have similar response rates to the overall study population, 17 (30%) patients had 17p deletion and 18 (32%) had fludarabine-refractory CLL.

1 of 4

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 18,162.32 +120.78 0.67%
S&P 500 2,121.90 +17.70 0.84%
NASDAQ 5,098.1190 +65.3680 1.30%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs