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news.Canada's Anormed has filed an investigational new drug application with the FDA for approval to begin its clinical program for its cancer drug candidate, AMD3100, in cardiac patients.
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The filing is the first step in evaluating the potential of AMD3100, a stem cell mobilizer, to help repair damaged heart tissue in patients who have suffered heart attacks.
“We are excited about the possibility that our lead drug candidate, AMD3100, may have additional therapeutic applications beyond the ongoing phase III study for stem cell transplant in cancer patients,” said Dr Michael Abrams, CEO and president of Anormed. “Although still at an early stage, the area of cardiac tissue repair presents an exciting new opportunity for AMD3100.”
The company hopes to initiate the first study, which will evaluate the safety of AMD3100 injections in patients who have recently had heart attacks, this year.
The therapeutic application of adult human stem cells to repair damaged tissue is an emerging field in medicine. Drugs that facilitate the mobilization and/or collection of these cells, such as AMD3100, may have a potential role in this field. There is clinical evidence that the presence of stem cells circulating in the bloodstream or directly injected into the hearts of patients who have suffered a heart attack, may result in improved cardiac function.