MELBOURNE (Dow Jones)--Regenerative medicine company Mesoblast Ltd. (MSB.AU) said Tuesday no safety issues have been identified during trials of its Revascor treatment for cardiovascular disease.
"Revascor was not associated with an increase in adverse or serious adverse events when compared to placebo," the company said in a presentation at the American Heart Association annual conference in Orlando, Florida.
Mesoblast said findings from its phase 2 trial of the treatment showed there was a 78% reduction in the rate of major adverse cardiac events in those who received the treatment, compared with the control group.
The company said those receiving Revascor had a reduced probability of cardiac death compared with those who didn't.
The phase 2 trial, aimed at patients with moderate-severe congestive heart failure, compared safety and efficacy outcomes in 45 patients who received a single injection of Revascor on top of usual care with 15 patients who received usual care alone.
Revascor is being developed as an "off-the-shelf" adult stem cell therapy. The company said it is currently being investigated for the treatment of acute and chronic cardiovascular indications, including congestive heart failure, acute myocardial infarction (heart attack) and chronic refractory angina.
Revascor, which is yet to receive regulatory approval, is set to undergo a phase 3 trial, to determine the effectiveness of the treatment compared with the current top standard, in the first half of 2012 in patients with congestive heart failure.
announcement pending, page-14
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