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Aastrom Biosciences Issues Statement on Unique Features of its
Bone Marrow Tissue Repair Cell Product and Technology
-- The Following is a Statement from R. Douglas Armstrong, Ph.D., Chief
Executive Officer and Chairman of Aastrom Biosciences, Inc. Regarding Recent
Article in New Scientist Magazine --
ANN ARBOR, Mich., April 26 /PRNewswire-FirstCall/ -- R. Douglas Armstrong,
Ph.D., Chief Executive Officer and Chairman of Aastrom Biosciences, Inc.
(NASDAQ:ASTM) today issued the following statement in response to an article
concerning certain aging, research laboratory cultured mesenchymal stem cells
and their potential ability to produce tumors in animals, published in the
April 21, 2005 edition of New Scientist magazine.
The report noted that mesenchymal stem cells can be managed safely using
standard cell culture expansion for 6-8 weeks. However, following multi-
passage long-term culture (4 to 5 months), these cells could undergo a
spontaneous transformation to cells that may form tumors. This long term
culture effect has been known for animal cells, and is now shown for human
cells as well.
Aastrom is developing patient-specific bone marrow-based products -- called
"Tissue Repair Cells" or TRCs -- for the repair or regeneration of human
tissues, utilizing the Company's proprietary technology.
The Aastrom TRC production process utilizes a small amount of the patient's own
bone marrow, the natural habitat for stem cells in the human body. The sample
is placed in a sterile cassette inside the AastromReplicell(R) System, a
proprietary, automated cell production system designed to mimic the natural
tissue growth environment of the human body. In a short 12-day production
cycle the bone marrow grows, filling the cassette and resulting in a much
higher number of early-stage stem and progenitor cells, which are then
harvested and administered back to the patient for therapeutic treatment.
There are a number of important differences that distinguish Aastrom's TRCs
from the cells that were discussed in the New Scientist article, which
synopsized the results of studies cited in an original article in Cancer
Research, Vol. 65, Pgs. 3035-3039, published April 15, 2005.
The experiments discussed in the original article used cells obtained from
adipose tissue, or fat, not from bone marrow. Once the adipose tissue was
collected, the investigators selectively isolated a specific type of cell,
removing it from its native tissue environment and thereby eliminating the
growth controls that the tissue environment provides. The long-term culture
approach used by the investigators was a multiple-passage process that can be
preferential for selective outgrowth of transformed cells that can form tumors.
Finally, the resultant human cells were administered to mice, a pre- clinical
laboratory model which does not always allow for a normal human tissue growth
opportunity.
In contrast, Aastrom's TRCs are produced in a natural mixed-cell environment,
in which the bone marrow stem cells remain associated with a portion of the
native tissue environment. TRCs are produced over a very short, defined period
of 12 days utilizing Aastrom's proprietary single-pass perfusion technology,
which maintains conditions that are conducive to a natural bone marrow growth
process. The 12-day process is much less than the 6 to 8 week process that was
shown to be safe in the Cancer Research study.
TRCs are not an isolated, pure stem cell product, but a mixture of cells found
naturally occurring in bone marrow, and include stem and other cells, which is
the natural mixture for augmenting tissue growth. Also, because TRCs are
derived from the patient being treated, there are no rejection issues.
Aastrom's TRCs have been administered safely to over 180 patients to date with
no evidence of tumorigenic activity or other serious issues. Aastrom is
currently conducting an FDA-approved multi-center human clinical trial of its
lead product, intended for the repair of severe long bone fractures, in the
United States, and is engaged in similar trials of this lead product in the EU.
About Aastrom Biosciences, Inc.
Aastrom Biosciences, Inc. (NASDAQ:ASTM) is developing patient-specific products
for the repair or regeneration of human tissues, utilizing the Company's
proprietary adult stem cell technology. Aastrom's strategic position in the
tissue regeneration sector is enabled by its proprietary Tissue Repair Cells
(TRCs), a mix of bone marrow-derived adult stem and progenitor cells, and the
AastromReplicell(R) System, an industry-unique automated cell production
platform used to produce cells for clinical use. TRCs are the core component of
the products Aastrom is developing for severe bone fractures, ischemic vascular
disease, jaw reconstruction and spine fusion, with Phase I/II level clinical
trials active in the U.S. and EU for some of these indications.
For more information, visit Aastrom's website at http://www.aastrom.com/.
This document contains forward-looking statements, including without
limitation, statements concerning product development objectives, potential
product applications, and potential advantages of the AastromReplicell(R)
System, which involve certain risks and uncertainties. The forward-looking
statements are also identified through use of the word "plan," and other words
of similar meaning. Actual results may differ significantly from the
expectations contained in the forward-looking statements. Among the factors
that may result in differences are clinical trial results, potential product
development difficulties, regulatory approval requirements, the availability of
financial and other resources and the allocation of resources among different
potential uses. These and other significant factors are discussed in greater
detail in Aastrom's Annual Report on Form 10-K and other filings with the
Securities and Exchange Commission.
CONTACTS:
Kris M. Maly or Kevin McGrath
Becky Anderson Cameron Associates
Investor Relations Department Phone: (212) 245-4577
Aastrom Biosciences, Inc.
Phone: (734) 930-5777
DATASOURCE: Aastrom Biosciences, Inc.
CONTACT: Kris M. Maly or Becky Anderson, Investor Relations Department
of Aastrom Biosciences, Inc., +1-734-930-5777; or Kevin McGrath of Cameron
Associates, +1-212-245-4577
Web site: http://www.aastrom.com/