Cardiome Pharma Continues Phase II Clinical Trial for Oxyapurinol in Congestive Heart Failure Treatment

Strategic Insights -

Cardiome Pharma Corp. has announced that its independent Data Safety Monitoring Board (DSMB) has recommended continuing the phase II randomized controlled clinical trial, OPT-CHF, evaluating oxyapurinol as an add-on treatment for class III-IV congestive heart failure. The trial will enroll 400 patients, with enrollment expected to complete by the end of 2004, and results projected to be available in the third quarter of 2005.

Key Takeaways:

  • The Cardiome DSMB unanimously voted to continue the study based on the first planned safety analysis of data from the first subset of patients to complete the 24-week trial.
  • The clinical trial will evaluate the safety and effectiveness of oxyapurinol in treating patients with moderate to severe symptomatic CHF (rated by the New York Heart Association as class III-IV).
  • Oxyapurinol, a xanthine oxidase inhibitor, sensitizes cardiac muscle cells to intracellular calcium, leading to increased cardiac oxygen-use efficiency, which is expected to improve clinical outcomes for CHF patients.
  • Cardiome's lead drug in the congestive heart failure (CHF) area is oxyapurinol, and the company believes that increasing the cardiac oxygen-use efficiency will improve the clinical outcomes for CHF patients.
  • The clinical trial will provide valuable insights into the safety and efficacy of oxyapurinol in treating CHF patients, which may lead to improved treatment options for this patient population.
  • Cardiome has been actively pursuing the development of oxyapurinol as a treatment for CHF, with the goal of improving the clinical outcomes for patients with this condition.

Statistics:

  • 400 patients will be enrolled in the clinical trial.
  • The clinical trial is expected to complete enrollment by the end of 2004.
  • Results are projected to be available in the third quarter of 2005.
  • Oxyapurinol sensitizes cardiac muscle cells to intracellular calcium, leading to increased cardiac oxygen-use efficiency, which is expected to improve clinical outcomes for CHF patients.

Sources:

  • NewsRx.com & NewsRx.net
  • Heart Disease Weekly
  • Cardiome Pharma Corp.