October 5, 2007
Aastrom announces positive results for critical limb ischemia drug
ANN ARBOR, Mich., USA - Aastrom Biosciences, Inc. (Nasdaq:ASTM)
leading regenerative medicine company, today announced positive
interim results from two separate research groups utilizing
autologous stem cell products manufactured with the Company's
proprietary Tissue Repair Cell (TRC) Technology platform.
The first study reported positive results from the use of Aastrom
Vascular Repair Cells (VRCs) in the treatment of chronic diabetic
foot wounds associated with critical limb ischemia (CLI). In another
presentation, positive results from the use of Aastrom Bone Repair
Cells (BRCs) in the treatment of osteonecrosis of the femoral head
were presented. Primary investigators from each of these research
groups presented data today at the 2nd Congress of the German Society
for Stem Cell Research in Wurzburg, Germany.
In an oral presentation, Dr. Bernd Stratmann of the Diabetes Center
at the Heart and Diabetes Center in North Rhine-Westphalia (Center),
Bad Oeynhausen, Germany, presented interim results from the first 13
patients treated in a multi-arm Phase I/II single-center clinical
trial to evaluate the safety of VRCs and normal bone marrow cells in
the treatment of chronic diabetic foot wounds associated with CLI.
Results reflect treatment experience from: four diabetic patients
with ischemia-related chronic tissue ulcers who were treated with
Aastrom VRCs, a cell mixture derived from the patient's bone marrow
that is processed using TRC Technology to generate large numbers of
predominantly mesenchymal stem and early progenitor cells; seven
patients who were treated with normal bone marrow cells; and two
standard of care patients who received no cells. All patients
received standard wound care as described by the American Diabetes
Association.
Twelve months post-treatment, all patients in the interim analysis
who were treated with VRCs reported no major amputations, no cell-
related adverse events, and healing of all open wounds. Of the seven
patients treated with normal bone marrow cells, five reported results
similar to the VRC-treated patients 12 months post-treatment, one
reported similar results to the VRC-treated patients 18 months post-
treatment, and one patient received a major amputation. For the two
standard of care patients who only received wound care (no cells),
one patient received a major amputation and one patient experienced
no improvement in wound healing after 12 months.
"These encouraging results indicate that VRCs are safe for
therapeutic use and could offer potential advantages over the current
standard of medical care in closing chronic wounds and in reducing
the risk of amputation for diabetic patients with CLI," said Dr.
Stratmann, who is a primary investigator in the trial along with
Stanley Kirana, M.D., and Prof. Diethelm Tschope, M.D., medical
director of the Center.
In a second oral presentation at the same meeting, clinical results
were presented by Ulrich Noth, M.D. of the Orthopaedic Institute,
Konig-Ludwig-
first use of Aastrom BRCs to treat patients suffering from
osteonecrosis of the femoral head. Osteonecrosis of the femoral head
involves the death of cells in the bone and marrow within the femur
head and in many cases leads to total hip replacement. Dr. Noth
presented data from 4 patients. All patients tolerated the procedure
well, have reported a reduction in hip pain with no signs of disease
progression, as determined by MRI and X-Ray, and were back to work
within 6 months after treatment. In addition, no cell-related adverse
events were observed and none of these patients have required hip
replacement surgery.
"There are currently no effective treatment options for terminating
or reversing this disease process. The use of cell-based therapies
has great potential and could play an important role in the treatment
of femoral head necrosis in the future," said Dr. Noth.
"In both of these studies, we see more encouraging safety and
efficacy data suggesting clinical benefits from treatment involving
products derived from Aastrom's Tissue Repair Cell Technology
platform. These data demonstrate, for the first time, that Aastrom's
cell products may have a beneficial long-term effect in these two key
indications: critical limb ischemia and osteonecrosis of the femoral
head. Although still early, the results presented here lend
substantial scientific support to our entire clinical development
program that is focused on autologous stem cell products for
regenerative medicine," said Elmar R. Burchardt, M.D., PhD., Vice
President, Medical Affairs of Aastrom.
About Aastrom Biosciences, Inc.
Aastrom is a leader in the development of autologous cell products
for the repair or regeneration of human tissue. The Company's
proprietary Tissue Repair Cell (TRC) Technology involves the use of a
patient's own cells to manufacture products to treat a range of
chronic diseases and serious injuries affecting bone, vascular,
cardiac, and neural tissues. Aastrom's TRC-based products contain
increased numbers of stem and early progenitor cells, produced from a
small amount of bone marrow collected from the patient. The TRC
Technology platform has positioned Aastrom to advance multiple
products into clinical development. Currently, the Company has a bone
regeneration product in Phase III development for the treatment of
osteonecrosis of the femoral head (called the ON-CORE trial), a
vascular regeneration product in Phase IIb development for the
treatment of critical limb ischemia (called the RESTORE-CLI trial),
and preclinical research programs targeting unmet needs in cardiac
and neural health. Aastrom product candidates to treat osteonecrosis
of the femoral head and dilated cardiomyopathy have been designated
for orphan drug status by the FDA. For more information, visit
Aastrom's website at www.aastrom.
The Aastrom Biosciences, Inc. logo is available at
http://www.primenew
Aastrom Biosciences, Inc.
Investor Relations Department
Kris M. Maly
(734) 930-5777
Cameron & Associates
Investors:
Kevin McGrath
(212) 245-4577
Berry & Company
Media:
Steve Zoegall
(212) 253-8881
© 2007 PrimeNewswire, Inc.
Source: Aastrom Biosciences, Inc.
http://www.checkbio
infoId=1338
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StemCells subscribers may also be interested in these sites:
Children's Neurobiological Solutions
http://www.CNSfoundation.org/
Cord Blood Registry
http://www.CordBlood.com/at.cgi?a=150123
The CNS Healing Group
http://groups.yahoo.com/group/CNS_Healing
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