Aastrom Biosciences Inc. said its experimental treatment for patients with a severe blocked-artery condition met the goals of a clinical trial, paving the way for a final-stage study before applying for regulatory approval.
The condition, called critical limb ischemia, can lead to pain, skin sores and amputation. The therapy, ixmyelocel-T, lowered by 62 percent over one year the risk of a major amputation of the leg treated, a doubling in wound size, new incidences of gangrene or death, the Ann Arbor, Michigan-based developer of treatments for cardiovascular diseases said today in a statement.
Results of the 72-patient study “provide compelling clinical evidence that ixmyelocel-T could represent a major advance in the treatment of patients with CLI who have no option for revascularization,” Chief Executive Officer Tim Mayleben said. “We look forward to initiating our pivotal Phase 3 clinical trial for ixmyelocel-T this quarter.”
About 1 million people in the U.S. have critical limb ischemia, Aastrom said on its website. People with the condition have severely blocked arteries that decrease blood flow to the legs, feet and hands, according to the Lakewood, Colorado-based Vascular Disease Foundation.
The data, from the second trial phase of three generally required by U.S. regulators, were presented today at the American Heart Association Scientific Sessions in Orlando. The therapy also met the study’s safety goals, showing no difference between the treated group and placebo, Aastrom said.
Aastrom declined 6.2 percent to $2.58 at the close of New York trading. The shares had gained 7.4 percent this year before today.