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Momentum and Appreciation, Aastrom Biosciences (ASTM)

ASTM’s shares rose to 1.91 (7.30%) beyond (10:30 am) the opening.

ASTM will be hosting a satellite session at the VEITHsymposium™ on 11/18/10 at 1:00 pm (EDT) featuring a presentation by Richard Powell, MD, Principal Investigator in the RESTORE-CLI clinical trial.

ASTM is conducting 3 late staged trials; IMPACT-DCM trial, a Phase 2 (cardiac regeneration) with surgical delivery of TRCs in patients with dilated cardiomyopathy (DCM) leading to severe chronic heart failure); DCM P2 trial with catheter delivery of TRCs and the RESTORE-CLI trial, a Phase 2b (vascular regeneration) in patients with CLI (critical limb ischemia).

  • Filed a Phase 3 CLI Special Protocol Assessment (NYSE:SPA) for its autologous cell therapy;
  • Compelling efficacy, safety results and anecdotal data provide a strong signal of the therapeutic benefit of autologous cell therapy in patients with critical limb ischemia (NYSE:CLI);
  • ASTM and ATEK Medical formed of a new strategic partnership  in which ATEK Medical will supply key components and technology which replaces a previous supplier relationship.;
  • ASTM has been granted fast track designation for their critical limb ischemia (CLI) cell therapy development program;
  • On 9/22/10, Sanofi-Aventis and Vical’s late-stage candidate, Temusi (NV1-FGF) failed a phase III program in patients with severe peripheral arterial disease (PAD). The failure of this phase III program could validate ASTM phase III ready autologous cell therapy treatment.

ASTM has made significant progress during the past 12 months and is now in a much stronger position to execute clinical programs and commercialize their autologous cell therapies.

Approximately 1 M people in the US suffer from Critical limb ischemia (CLI). This disease results in more than 160,000 amputations each year. 

  • CLI is the term used for patients with chronic ischemic rest pain, ulcers, or gangrene that is attributable to inadequate blood flow or arterial occlusive disease;
  • CLI is typically identified as the end stage of peripheral arterial disease. CLI is the most severe form of PAD, and is typically the end stage of the disease;
  • CLI is a severe obstruction of the arteries which decreases blood flow to the extremities (hands, feet and legs) and has progressed to the point of severe pain and even skin ulcers or sores;
  • Patients with CLI often suffer from severe pain caused by ischemia, tissue loss, ischemic neuropathy or a combination of these factors;
  • The pain typically occurs at night when the patient is resting, and episodes can last for hours.

A large percentage of patients with CLI have coexisting diseases, such as cardiovascular and renal disorders. CLI patients also are at high risk for myocardial infarction, stroke, and vascular death. Therefore, prompt referral to a specialized vascular center improves the success of their treatment and reduces the systemic risk in this population;

  • People with CLI face a high risk of amputation and in some cases death;
  • No effective pharmacologic therapy is available, and amputation is often the only option left, but is associated with an even worse prognosis: perioperative mortality is 5% to 20% and a 2nd amputation is required in 30% of all patients.