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ANN ARBOR, Mich., Jan. 20, 2011 (GLOBE NEWSWIRE) -- Amit N. Patel, MD, MS, associate professor of surgery at the University of Utah School of Medicine and national principal investigator in Aastrom's U.S. Phase 2 IMPACT-DCM clinical trial, and Sharon Watling, Pharm.D., Aastrom's vice president of clinical and regulatory, today reviewed findings from the company's IMPACT-DCM and RESTORE-CLI clinical studies in presentations at The Sixth International Conference on Cell Therapy for Cardiovascular Disease in New York City.
Dr. Patel reviewed six-month interim results from the Phase 2 IMPACT-DCM clinical trial investigating the surgical administration of the company's expanded autologous mixed-cell therapy in patients with dilated cardiomyopathy (DCM). Dr. Patel reviewed previously reported results indicating that treatment is safe and showing that adverse events were minor and associated only with the surgical procedure. No AEs were reported associated with the therapy and AEs were similar in the treatment and control groups. Dr. Patel also reviewed findings showing consistent and positive trends in quality of life, functional and structural parameters in the treatment group. Aastrom expects to report 12-month data from the IMPACT-DCM clinical study in the second quarter of 2011 and six-month results from the DCM catheter Phase 2 clinical study in the third quarter of 2011.
Dr. Watling provided a summary of previously reported interim results from the company's U.S. Phase 2b RESTORE-CLI clinical trial investigating treatment with the company's expanded autologous mixed-cell therapy in patients with critical limb ischemia (CLI). Aastrom plans to conduct two Phase 3 clinical studies of its expanded autologous therapy in patients with CLI and has received Fast Track designation from the FDA for this program. The company has received initial responses from the FDA regarding the special protocol assessments for the two Phase 3 studies, which were submitted in October 2010.
"We are pleased with the initial responses from the FDA, especially for the no-option CLI study. We look forward to continuing to work with the FDA to finalize both special protocol assessments for the Phase 3 CLI program in the months ahead," said Tim Mayleben, president and CEO of Aastrom Biosciences. The Company expects to initiate the no-option Phase 3 trial by mid-2011.