Vasogen Plans Confirmatory Study of Celacade(TM) in Chronic Heart Failure to Support U.S. Regulatory Approval
MISSISSAUGA, ON, Sept. 17 /PRNewswire-FirstCall/ - Vasogen Inc. (NASDAQ:VSGN; TSX:VAS), today announced plans for a confirmatory study that would support an application for regulatory approval in the United States of its Celacade technology for the treatment of patients with NYHA Class II heart failure. The planned trial design indicates that as few as 300 patients could provide sufficient data to confirm the finding of the phase III ACCLAIM trial which demonstrated a 39% reduction (p equals 0.0003) in the risk of death or cardiovascular hospitalizations for the large pre-specified subgroup of 689 NYHA class II heart failure patients.
'We are extremely pleased with the proposed design for a confirmatory trial of Celacade in patients diagnosed with NYHA Class II heart failure. For the purpose of obtaining U.S. regulatory approval, an adaptive trial design utilizing a Bayesian statistical approach provides us with the possibility of confirming our earlier results with as few as 300 patients,' commented Chris Waddick, President and CEO of Vasogen. 'We are now preparing to meet with the FDA, with the objective of obtaining formal FDA agreement with respect to our proposed trial design prior to the end of the year. Furthermore, we continue to be on track for the initial commercialization of Celacade by year-end in the European Union, where Celacade has already received CE Mark regulatory approval for the treatment of NYHA Class II heart failure.'
In May, Vasogen met with the FDA to review the ACCLAIM trial data, which demonstrated a 39% reduction (p equals 0.0003) in the risk of death and cardiovascular hospitalizations for the large pre-specified subgroup of 689 NYHA class II heart failure patients. As a result of the meeting, the FDA strongly recommended that Vasogen conduct a confirmatory study to support a U.S. Pre-Market Approval filing for Celacade for NYHA Class II heart failure patients and also recommended that the Company consider utilizing a Bayesian approach. This approach involves a trial design methodology that allows utilization of prior trial results to contribute to the statistical power of a confirmatory study and therefore provides the opportunity to significantly reduce the number of required patients, as well as the cost and duration of the study. As a result of the FDA's recommendations, Vasogen retained Berry Consultants and Dr. Donald A. Berry, Head, Division of Quantitative Sciences and Chairman, Department of Biostatistics, The University of Texas MD Anderson Cancer Center, and a world recognized authority in the area of Bayesian and adaptive trial design, to assist with the development of a confirmatory study. The proposed trial design indicates that as few as 300 patients could provide sufficient data to confirm the finding of the ACCLAIM trial. Furthermore, the use of an adaptive clinical trial design also provides the flexibility to increase the sample size up to 600 patients should additional data be required.
As in Vasogen's ACCLAIM study, it is expected that the primary endpoint of the planned study will be death or first cardiovascular hospitalization. The double-blind, placebo-controlled study is also expected to have similar inclusion/exclusion criteria as ACCLAIM, with all patients on standard-of-care medication for heart failure. If successful, this trial is expected to support an application for regulatory approval in the United States of Vasogen's Celacade technology for the treatment of patients with NYHA Class II heart failure. The final study design and sample size are subject to approval by the FDA. The Company is in the process of establishing a Steering Committee that will provide input to the final study design, which will then be subject to approval by the FDA.
Heart failure, most frequently resulting from coronary artery disease or hypertension, is a debilitating syndrome in which the heart's ability to function as a pump is impaired. Patients with heart failure experience a continuing decline in their health, resulting in an increased frequency of hospitalization and premature death. According to the Heart Failure Society of America, heart failure is the only major cardiovascular disease with prevalence and incidence on the rise. Heart failure, which is now often referred to as an epidemic, is estimated to affect 12 million individuals in North America and Europe, and an estimated 4.4 million have NYHA Class II symptomatic impairment.
About Celacade:
Therapy utilizing the Celacade technology targets the inflammation underlying chronic heart failure and other cardiovascular diseases. Inflammation is a normal response of the immune system to cellular injury caused by infection, trauma, or other stimuli. During the inflammatory process, immune cells release a number of factors, including cytokines - potent chemical messengers that modulate inflammation and facilitate the healing process. While this inflammatory process is usually self-limiting, it can persist, become chronic, and lead to a number of serious medical conditions.
During a brief outpatient procedure, a small sample of a patient's blood is drawn into Vasogen's Celacade single-use disposable cartridge and exposed to controlled oxidative stress utilizing Vasogen's proprietary Celacade medical device technology. Oxidative stress is a factor known to initiate apoptosis, a physiologic process that is inherently anti-inflammatory. The treated blood is then administered to the same patient intramuscularly. An initial course of treatment comprising three consecutive outpatient procedures is administered over a two-week period, and treatments are continued once per month thereafter.
surf's up......crikey
