Will Aastrom Hit Its Stride?

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Regenerative medicine - a new catch word in health care is one of the hottest areas of research in contemporary science. At the 5th Annual Stem Cell Summit to be convened in New York on February 16, regenerative medicine company Aastrom Biosciences Inc. (ASTM) is scheduled to make a presentation.

The company's proprietary Tissue Repair Cell, or TRC, technology uses a patient's own cells (harvested from bone marrow) for the treatment of severe, chronic cardiovascular diseases. Since a patient's own cells are used, the risk of cell rejection is minimized and disease transmission risk from donor tissue is also eliminated.

Aastrom currently has two phase II trials underway - a phase II cardiac regeneration clinical trial dubbed IMPACT-DCM in patients with severe chronic heart failure and a phase IIb vascular regeneration clinical trial dubbed RESTORE-CLI in patients with critical limb ischemia.

The IMPACT-DCM trial is a 40-patient randomized phase II trial, which evaluates the surgical delivery of Cardiac Repair Cells, or CRCs, directly into the human heart muscle for the treatment of severe chronic heart failure. IMPACT-DCM, the first clinical trial in the U.S., which began in November 2008, has enrolled 37 patients as of December 2009. The company is also planning a phase II clinical trial in the U.S. to evaluate the catheter delivery of CRCs for the treatment of severe chronic heart failure.

In mid-November of 2009, the company presented interim findings of the IMPACT-DCM trial, which suggested that the majority of patients treated to date with Cardiac Repair Cells, or CRCs, have shown improvements in their heart failure classification, while patients in the control group, who did not receive CRCs, did not have a similarly improved outcome. The interim results of the IMPACT-DCM trial are expected to be released this quarter. (Q1, 2010).

The RESTORE-CLI trial evaluates Vascular Repair Cells, or VRCs, in the treatment of patients suffering from the most severe form of peripheral arterial disease, a condition known as critical limb ischemia or CLI. As of December 2009, 79 patients were enrolled in the study. The interim clinical data from the trial are also expected this quarter.

Aastrom went public in February 1997, offering its shares at a price of $7 each. Since its inception in 1989, the company has incurred losses and the accumulated net loss as of September 30, 2009 is approximately $199 million. The company is slated to release its second-quarter results on February 5.

Late last month, the company completed a previously announced underwritten public offering of its units from which it received about $12.4 million in net proceeds.

Shares of Aastrom have been trading below $1 continuously since November 2007 and currently trade around their yearly low of $0.20. Between December 2007 and October 2009, the company had come close to getting delisted from the Nasdaq. The company now has time until March 31, 2010 to regain compliance to continue to be listed on the Nasdaq.

Effective December, 2009, Timothy Malyeben took over as the new CEO, President and CFO, replacing George Dunbar. While Dunbar assumed the role of Chairman of the Board, Nelson Sims was appointed lead director.

Will the new management and the two mid-stage trials, whose results are expected this quarter, help Aastrom hit its stride? Stay tuned...

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