GTx Announces Positive Results from Pivotal Phase III ADT Clinical Trial of ACAPODENE

Strategic Insights -

Men with advanced prostate cancer on androgen deprivation therapy (ADT) who received ACAPODENE had significantly lower total cholesterol, LDL, and triglyceride levels compared to placebo. The lipid interim analysis of the pivotal Phase III ADT clinical trial revealed a reduction in total cholesterol (-7.1%; p=0.001), LDL (-9.0%; p=0.003), and triglyceride (-20.1%; p=0.009) levels. Additionally, the total cholesterol/HDL ratio decreased by -11.7% (p "The potential of ACAPODENE to address multiple serious side effects of ADT would mark important progress in the care of prostate cancer patients," said Dr. Matthew R. Smith, lead Principal Investigator of the Phase III ADT clinical trial.

Key Takeaways:

  • GTx has announced positive results from a lipid interim analysis of the pivotal Phase III ADT clinical trial of ACAPODENE.
  • The lipid analysis revealed significant reductions in total cholesterol (-7.1%), LDL (-9.0%), and triglyceride (-20.1%) levels in patients receiving ACAPODENE compared to placebo.
  • The total cholesterol/HDL ratio decreased by -11.7% in patients receiving ACAPODENE.
  • The primary endpoint of the trial is a reduction in vertebral fractures.
  • Secondary endpoints include improvements in bone mineral density (BMD), hot flashes, gynecomastia, and lipid profiles.
  • Final data from the trial is expected in the second half of 2007.
  • A previous interim analysis in December 2005 revealed significant increases in BMD in patients receiving ACAPODENE.
  • GTx is conducting the trial in approximately 1,400 men at over 150 sites in the United States and Mexico under a Special Protocol Assessment with the FDA.

Statistics:

  • Patients receiving ACAPODENE had a -7.1% reduction in total cholesterol levels (p=0.001).
  • Patients receiving ACAPODENE had a -9.0% reduction in LDL levels (p=0.003).
  • Patients receiving ACAPODENE had a -20.1% reduction in triglyceride levels (p=0.009).
  • The total cholesterol/HDL ratio decreased by -11.7% in patients receiving ACAPODENE.

Sources:

  • GTx Inc., "GTx Announces Positive Results from Pivotal Phase III ADT Clinical Trial of ACAPODENE," Press Release, (Exact date not provided in the source material)
  • Harvard Medical School, "Matthew R. Smith, M.D., Ph.D.," (Exact date not provided in the source material)
  • GTx Inc., "GTx Announces Positive Results from Pivotal Phase III ADT Clinical Trial of ACAPODENE," (Exact date not provided in the source material)
  • GTx Inc., "GTx Announces Positive Results from Pivotal Phase III ADT Clinical Trial of ACAPODENE," (Exact date not provided in the source material)