Scimitar Equity Blog

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 (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 2^nd 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!