Vasogen heart therapy cuts risk in 70 pct of patients
|
|
A heart treatment from Canadian biotech firm Vasogen Inc., which failed a key clinical trial hurdle in June, still helped more than 70 percent of patients, researchers said on Sunday.
Vasogen Chief Executive David Elsley told Reuters 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.
If all goes well Celacade could go on sale in Europe in mid-2007. Elseley - who previously said he expected to have to do another study to win U.S. approval - added the firm would now also discuss the results with U.S. and Canadian regulators.
Shares in Vasogen fell more than 70 percent in June on news Celacade had not reached its primary goal of significantly reducing the overall risk of death and cardiovascular hospitalisation in a 2,408-patient Phase III clinical trial.
But a review of the full data set released on Sunday showed there was a 21 percent reduction in risk in a 1,746 patient sub-group who had not progressed to the more advanced stages of heart failure.
Principal investigator Dr Guillermo Torre-Amione of the DeBakey Heart Center of The Methodist Hospital in Houston, Texas, said the results provided “compelling evidence” that Celacade could help an important group of heart failure patients.
SEEKING A PARTNER
Elsley said he was 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.
“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,” he said in an interview. “We are looking at a very broad population.”
The latest results showed Celacade helped not only patients with class II chronic heart failure, as assessed by the New York Heart Association, but also sicker class III and IV patients, provided they had not suffered a previous heart attack.
Confidence in the company - which has only enough cash to fund operations for another year - was dealt a serious blow by the initial setback to hopes for its leading product.
But 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.
“We certainly expect the market will be impressed by this data,” he said.
Vasogen’s Celacade technology involves taking a small sample of blood from patients with heart failure and treating it to target the chronic inflammation associated with cardiovascular disease. It is then re-administered to the patient intramuscularly.
Heart failure occurs when the heart is unable to maintain adequate circulation of blood in the body’s tissues, resulting in shortness of breath, excessive tiredness and fluid buildup.
Print Version
Tell-a-Friend comments powered by Disqus
