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Finding its Stride, Aastrom Biosciences (NASDAQ: ASTM)

Aastrom is a leader in regenerative medicine developing autologous cell products for the treatment of severe, chronic cardiovascular diseases. ASTM’s proprietary Tissue Repair Cell (NYSE:TRC) technology expands the numbers of stem and early progenitor cells from a small amount of bone marrow collected from the patient.

Updating our blogs on 10/25/09 and 11/9/09:

  • ASTM is conducting a Phase 2 cardiac regeneration clinical trial (the IMPACT-DCM trial) in patients with dilated cardiomyopathy (DCM — severe chronic heart failure),
  • A Phase 2b vascular regeneration clinical trial (the RESTORE-CLI trial) in patients with critical limb ischemia (CLI — the most severe form of peripheral arterial disease),
  • Aastrom also recently announced it will initiate its U.S. Phase 2 clinical trial to evaluate the catheter delivery of CRCs for the treatment of DCM.

On Sunday, 11/15/09, Dr. Amit N. Patel, ASTM’s  lead investigator for the IMPACT-DCM clinical trial presented interim data from the ASTM trial in a session entitled “Surgical Applications of Angiogenesis and Myogenesis”  in Orlando, Florida.   On the same day, Dr. Timothy Henry, one of the principal investigators in ASTM’s RESTORE-CLI clinical trial and Dr. Subhash Thakur took part in a satellite event entitled “Can We Really Grow New Blood Vessels” (also in  Orlando).

Synopses: The RESTORE-CLI clinical trial; patient experienced a reduction in pain within 1 month of treatment and became pain and narcotic-free within 3 1/2 months.

  • There was a notable decrease in the loss of healthy tissue on both hands and an increase in healing of the patient’s fingers at 3 months post-treatment; an objective improvement in blood flow was measured by laser doppler imaging in the patient’s fingers. The most important finding is that the patient showed wound healing at 9 1/2  months,

 

  • The IMPACT-DCM trial: 7 treatment patients who completed the 1-month follow-up visit, 1 patient had improved to NYHA Class I and 3 patients had improved to Class II.  In contrast, at the 1-month follow-up visit, the NYHA Class did not improve in 3 of the 5 control patients.  Of the 6 treatment patients who have completed the 3 month follow-up visit – 1 patient improved to NYHA Class I and patients improved to Class II.  In contrast, at the 3-month follow-up visit, the NYHA Class did not improve in 4 of the 5 control patients. Of the 5 treatment patients who have completed the 6-month follow-up visit, 2 patients improved to NYHA Class I,  2  patients improved to Class II and 1 patient deteriorated to  NYHA Class IV.  In contrast, at the 6-month follow-up visit, the NYHA Class did not improve in 3 of the 5 control patients, including 1 patient who deteriorated to NYHA Class IV.

Bottom Line: These presentations are a further evolution of data by Dr Patel (the lead investigator of the cardiac DCM trial) presented a few months ago at another meeting. This data which includes those earlier patients tracked for a longer time showed – continued improvement – with earlier patients as well as more recent ones:

  • ASTM is meeting its enrollment goal despite 2 clinical holds. This goal is to have all 40 patients enrolled by year end. Then 6 months later… sometime around 6/10; the 6 month data will be available for the entire trial (asked for by FDA),
  • No other trial is currently looking at both ischemic as well as non-ischemic patients with significant diagnostic testing and image monitoring;  ASTM will then meet with the FDA for Phase 3 discussions of a surgical delivery trial. The 2nd trial IND was recently approved within the 30 day time frame compared and contrasted to Geron and others who have – taken – years,
  • This data also tracks similar patients with different delivery, e.g. catheter and less invasive – opening the potential market – to BOTH cardiac and thoracic surgeons and – NOW – cardiologists,
  • Another dual track for the future …,
  • The data from Dr’s Henry and Thakur from the presentation of limb ischemia patients (outside ASTM’s trial which is double blinded) was conducted in Germany; these wounds (legs and feet) were NOT healing with the usual standard of care. The cell therapy treatment results – should – give ASTM the confidence to start the largest Phase 2 critical limb ischemia trial with FDA. This trial will be unblinded after the 1 year time point of 30 treated patients; as this time point was reached a couple of weeks ago at the end of 10/09. The data will be crunched and likely during Q3/10 (ASTM has a June 30 fiscal year);  it could be seen what ASTM has for next round of discussions with FDA. This will be a 120-150 patient phase 2 trials (the largest of its kind),
  • Their was a single US patient ASTM treated (for limb ischemia) following the FDA permission to do so outside their active trial for hand and finger problems,
  • This data of the hands are nothing – short of impressive – as the patient has – NO – pain any longer – which is a really big deal… he is a happy camper and  has been this way now for over 1 year,
  • Doctors perceive a “cure” here as it has – NEVER – been done before,
  • It is not too hard not to want to connect the dots to what ASTM is going to do with the blinded FDA Phase 2 trial until they analyze the data … given these results and the German patient,
  • These are very encouraging signs!