AVI BioPharma Announces Positive Results in AVAIL Phase II Clinical Trial for Resten-NG

Strategic Insights -

Avi BioPharma, Inc. has announced positive results from its AVAIL phase II clinical trial investigating the effects of antisense drug Resten-NG against cardiovascular restenosis. The trial, led by Nicholas Kipshidze, MD, an interventional cardiologist from Lenox Hill Hospital in New York, demonstrated statistically significant efficacy in preventing restenosis and significantly reducing neointimal growth.

Key Takeaways:

  • The AVAIL phase II clinical trial, which enrolled 33 coronary artery disease patients with a high risk of restenosis, showed a 75% reduction in restenosis rate among patients who received a therapeutic dose of Resten-NG compared to the control arm.
  • Resten-NG demonstrated statistically significant efficacy in preventing restenosis determined by both quantitative angiography and intravascular ultrasound.
  • The binary restenosis rate of 33% in the control arm was reduced to approximately 8% among patients who received a therapeutic dose.
  • Resten-NG significantly reduced neointimal growth, a key contributor to angioplasty intervention failure.
  • AVI plans to initiate phase III clinical trials with its own drug-eluting stent in Europe, which could lead to CE Mark approval if successful.
  • AVI intends to out-license its DES package for development in the United States following the initiation of the trial.

Statistics:

  • 33 coronary artery disease patients were enrolled in the AVAIL phase II clinical trial.
  • 75% reduction in restenosis rate among patients who received a therapeutic dose of Resten-NG.
  • 33% binary restenosis rate in the control arm.
  • 8% binary restenosis rate among patients who received a therapeutic dose of Resten-NG.
  • Resten-NG was delivered using the Infiltrator catheter and two dose levels within the treatment arms.

Sources:

  • AVI BioPharma, Inc. (AVII) - (NewsRx.com & NewsRx.net)
  • Nicholas Kipshidze, MD, Lenox Hill Hospital (New Orleans, 2004)
  • American Heart Association's annual meeting (New Orleans, 2004)