Researchers said that although the heart treatment from Canadian biotech firm Vasogen Inc. failed a key clinical trial hurdle in June, has still helped more than 70 per cent of patients.//
Vasogen chief executive officer David Elsley said that he was confident the detailed analysis presented at the World Congress of Cardiology meant its Celacade device-based therapy now had a promising commercial future.
According to Celacade if all goes well it could go on sale in Europe around the middle of 2007, although more clinical studies would be needed before it is launched in the United States.
In June when news that Celacade had not reached its primary goal of significantly reducing the overall risk of death and cardiovascular hospitalization in a 2,408-patient Phase III clinical trial shares in Vasogen fell more than 70 per cent.
However on review of the full data set released yesterday it was seen that there was a 21-per-cent reduction in risk in a 1,746 patient sub-group and they had not progressed to the more advanced stages of heart failure.
Researcher, Dr. James Young of the Cleveland Clinic Foundation said ,"The significant risk reduction observed on top of optimal heart failure therapy in over 70 per cent of study patients who were not in the more advanced stages of the condition -- and the consistency of the risk reduction across a number of different analyses -- are very compelling."
According to Mr. Elsley he was already in advanced discussions with a number of potential partners who could market Celacade, initially in Europe, where the treatment already has a CE mark, or regulatory approval.
He said, "Our therapy has been shown to be effective in patients that have not progressed to late-stage disease, at which point they become refractory to intervention. We are looking at a very broad population."
The recent review showed that Celacade helped patients with class II chronic hear
t failure, according to the assessment by the New York Heart Association as well as the more ailing class III and IV patients, provided they had not suffered a previous heart attack.
The initial setback to the hopes for Celacade had led to loss of confidence in the company But Mr. Elsley said he believed Vasogen's fortunes had turned, adding that the group hoped to receive a cash injection under a future Celacade marketing deal.
He said, "We certainly expect the market will be impressed by this data."
The Celacade technology involves taking a blood sample from patients with heart disease and treating it to target the chronic inflammation associated with cardiovascular disease. It is then re-administered to the patient intramuscularly.
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