ASTM Upcoming catalysts in 2011

ASTM looks to have a busy 2H 2011 with the anticipated start of the ph3 trial for Ixmyelocel-T in critical limb ischemia cases and ph2 results of Ixmyelocel in DCM.  See a summary below.

Drug/Compound:  Ixmyelocel-T

Target:
Patient-specific multicellular therapy expanded from a patient's own bone marrow and delivered directly to damaged tissues, this trial is focused on the potential treatment for critical limb ischemia.

Catalyst: 
In October 2010, Aastrom submitted two SPA requests to the FDA, one for a “no option” patient population and another for a “poor option” patient population. The no option SPA request focuses on patients that have exhausted all other treatment options with the exception of amputation. The poor option SPA request focuses on patients that have not yet exhausted all other treatment options; however the options available are associated with poor outcomes.  These will pave the way toward the start of phase 3 trials.

Timing: July/August 2011
--------------------------------------------------------------------------------------------------------

Drug/Compound: ixmyelocel-T

Target 
Dialated Cardiomyophaty, a condition in which the heart becomes weakened and enlarged, and it cannot pump blood efficiently. The decreased heart function can affect the lungs, liver, and other body systems.

Catalyst  Ph2 surgical trial program of ixmyelocel-T in dilated cardiomyopathy, dubbed IMPACT-DCM, initiated with 40 patients in Q42008. The six-month data from the IMPACT-DCM interim analysis, ixmyelocel-T is safe and no adverse events were found to be associated with the therapy. The 12-month data from the IMPACT-DCM clinical study will be reported in Q3. 

Timing: Q32011

--------------------------------------------------------------------------------------------------------

 

Drug/Compound: ixmyelocel-T

Target: 
Dialated Cardiomyophaty a condition in which the heart becomes weakened and enlarged, and it cannot pump blood efficiently. The decreased heart function can affect the lungs, liver, and other body systems.

Catalyst:
ph2 initiated in April 2010 and has 21 patients enrolled in the study. Aastrom expects to report six-month results from the Catheter-DCM phase 2 trial in Q32011


Timing: Q32011



Disclosures: no position or plan to take in next 72hrs.