Combating inflammation associated with heart failure
A new treatment uses a modified sample of a patient's own blood to stimulate the immune system to fight chronic inflammation that damages the heart.
Under development by Ontario based Vasogen Inc., the immune modulation therapy is called Celacade™.
The Celacade system treats the patient's blood in a machine that is slightly larger than a desktop computer.
Photo courtesy of Vasogen Inc.
How does it work?
Celacade therapy is performed once a month during a 30-minute outpatient visit, reports Glenn Neumann, Director of Investor Relations for Vasogen Inc. A nurse withdraws 10 mL of the patient's blood and transfers the sample to the Celacade machine where it is exposed to heat, oxygen and ultraviolet light for three minutes. The modified blood is then injected back into the patient.[1]
When the modified blood cells re-enter the body, a series of biologic responses is triggered, most notably an increase in the production of chemical messengers (cytokines) that decrease inflammation.[1] This response is believed to slow or stop the chronic inflammatory process responsible for damaging the heart.
Patient Group
Celacade treatment is intended for patients with chronic heart failure.[2] Heart failure occurs when the heart cannot pump enough blood to meet the body's needs. It is often a result of coronary artery disease and/or high blood pressure. Treatment usually includes medication and lifestyle changes such as diet adjustment and smoking cessation. Heart failure affects more than 400,000 Canadians, with over 50,000 new cases annually.[3] In 2002, more than 4,500 Canadians died from heart failure.[4]
Regulatory approval
Celacade is not currently licensed by Health Canada or the US Food and Drug Administration.
Evidence
A randomized, double-blind, placebo-controlled Phase II trial that enrolled 75 patients with chronic heart failure on standard therapy found a statistically significant reduction in the risk of death and all-cause hospitalizations in patients who underwent treatment with Celacade for six months compared with patients who received placebo.[1] There were 39 serious adverse events reported, including one death, among 14 patients receiving Celacade treatment; compared with 67 serious adverse events, including seven deaths, in 24 patients who received placebo. None of the events were considered to be treatment related.
Completion of a Phase III clinical trial (ACCLAIM), which includes 2,400 patients, was expected by the end of 2005.[2]
Cost
The cost of Celacade treatment is unknown.
Other indications
Celacade is being studied for the treatment of patients with intermittent claudication, a painful leg condition that is associated with peripheral artery disease. However, Vasogen Inc. prematurely halted its phase III trial for this indication in August 2005 due to a possible lack of effectiveness.[5] The final results of this trial have not been released.
References
[1] Torre-Amione G, et al. Am J Cardiol 2005; 95(11A):30C-7C.
[2] Vasogen receives CE mark for Celacade™ in Europe for the treatment of chronic heart failure. Mississauga (ON): Vasogen; 2004. Available: http://www.vasogen.com/sec/pr_1075729253.
[3] Kostuk WJ. CMAJ 2001; 165(8):1053-5.
[4] Death, by cause: heart failure [table 102-0529]. Ottawa: Statistics Canada; 2002.
[5] Vasogen announces the early close out of the SIMPADICO Peripheral Arterial Disease trial [news release]. Vasogen Inc.; 2005 Aug 30. Available: http://www.vasogen.com/sec/pr_1125371515.