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

Array BioPharma’s ARRY-797 Meets Primary Endpoint In Clinical Proof Of Concept Trial In Osteoarthritis Patients Whose Pain Is Poorly Controlled By NSAIDs

To further explore the safety and tolerability of ARRY-797, Array is currently conducting a multiple ascending dose trial in healthy volunteers at doses up to 2.5-fold higher than those evaluated in the osteoarthritis pain trial. ARRY-797 has been well-tolerated in this trial to date, and greater QTc prolongations were observed at these higher dose levels. No subject in either trial exhibited an absolute QTc interval >500 msec or a change from baseline >60 msec, two values cited by regulatory authorities, including the FDA, as thresholds of particular concern for cardiac arrhythmia. These QTc observations warrant further evaluation.

“These results, together with our earlier studies in acute pain, provide evidence that ARRY-797 delivers therapeutic utility in both acute and chronic pain settings,” said Ron Squarer, Chief Executive Officer, Array BioPharma. “Given the scope of a development program in pain, Array will aggressively seek a partner to maximize the value of this drug.”

About the Osteoarthritis Trial

The Phase 2 trial was a 28-day double-blind, active- and placebo-controlled study in 157 patients with osteoarthritis of the knee who had moderate-to-severe chronic pain despite the use of NSAIDs. Patients were randomized (1:1:1) to receive ARRY-797, placebo or oxycodone ER while continuing their use of NSAIDs. The primary endpoint of the trial was the change in the WOMAC ® pain subscale from Baseline to Week 4 compared to placebo. Secondary endpoints included safety and pharmacokinetic assessments, WOMAC ® physical function subscale, WOMAC ® stiffness subscale, responder analysis and the Patient’s Global Impression of Change.

About Osteoarthritis

Osteoarthritis, the most common form of arthritis, affects well over 20 million people in the U.S. and results in significant utilization of health care resources. A number of medications are currently available for the treatment of osteoarthritis pain, primarily NSAIDs and opioids; however, a significant unmet medical need remains. Opioids, although providing significant analgesic effects, are limited by tolerability issues (for example, somnolence, nausea, vomiting and constipation) and also suffer from the potential for abuse. NSAIDs offer only partial pain relief and are associated with renal, cardiovascular and gastrointestinal safety concerns.

2 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 18,010.68 -115.44 -0.64%
S&P 500 2,107.39 -13.40 -0.63%
NASDAQ 5,070.0260 -27.95 -0.55%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs