Aastrom Biosciences Receives NIH Grant Extending Proprietary Adult Stem Cell Process to Other Tissues
August 16 2005 - 5:45AM
PR Newswire (US)
-- Phase II Grant to Support Bone Formation and Vascularization
Capabilities of Company's Tissue Repair Cells -- ANN ARBOR, Mich.,
Aug. 16 /PRNewswire-FirstCall/ -- Aastrom Biosciences, Inc.
(NASDAQ:ASTM) today announced that it has received a Small Business
Innovation Research Phase II grant from the National Institutes of
Health (NIH) entitled "Clinical-Scale Production of Osteoprogenitor
Cells." The two- year Phase II grant award from the National
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
totals $740,000, of which $324,000 has been received for the first
year of this study. This Phase II grant award follows a Phase I
grant issued to Aastrom in 2003 by the NIH's National Institute of
Arthritis and Musculoskeletal and Skin Diseases. Aastrom's Tissue
Repair Cells (TRCs), a bone marrow-derived adult stem and
progenitor cell mixture, have been shown to form bone and small
blood vessel tubes in laboratory tests. This new grant will support
investigations to further increase the overall numbers of the
targeted cells thought to be especially important for bone
regeneration. This includes studies of the cells contained in TRCs,
to better understand how accessory cells support the growth of stem
and progenitor cells so they are optimized when the surgeon is
ready to use them for bone or vessel regeneration. Another
significant goal of this study is the evaluation of Aastrom's
unique cell production process in the AastromReplicell(R) System to
facilitate the transition to commercial- level cell manufacturing.
"Considering the highly competitive nature of NIH awards, we are
very excited to receive funding to continue our work using TRCs for
tissue regeneration in multiple medical indications," said Janet M.
Hock, B.D.S., Ph.D., Chief Science Officer and Vice President
Global Research of Aastrom. "Further understanding how TRCs
contribute to the regeneration of blood vessels should allow us to
better utilize our cell products for bone regeneration in
orthopedic applications, and for other conditions where regulated
revascularization is needed." The studies supported by this grant
will be completed at Aastrom under the direction of Kristin Goltry,
Ph.D., in collaboration with Case Western Reserve University, under
the direction of James Dennis, Ph.D., and with the University of
Michigan, under the direction of James Goulet, M.D. Dr. Goulet is a
principal investigator in Aastrom's Phase I/II multi-center human
clinical trial for the treatment of severe bone fractures,
currently being conducted at 5 sites in the United States,
including the University of Michigan Health Center in Ann Arbor.
The other participating centers are: Lutheran General Hospital,
Park Ridge, IL, William Beaumont Hospital, Royal Oak, MI, Lutheran
Medical Center, Brooklyn, NY, and the University of Nebraska
Medical Center, Omaha, NE. About Tissue Repair Cells Tissue Repair
Cells (TRCs) are Aastrom's proprietary mixture of bone
marrow-derived adult stem and progenitor cells produced using
patented single- pass perfusion technology in the
AastromReplicell(R) System. The clinical procedure begins with the
collection of a small sample of bone marrow from the patient's hip
in an outpatient setting. TRCs are then produced in the automated
AastromReplicell System over a 12-day period. It has been
demonstrated in the laboratory that TRCs are able to develop into
different types of tissue lineages in response to inductive
signals, including blood, bone, cartilage, adipose and vascular
tubules. In previous clinical trials, TRCs have been shown to be
safe and reliable in regenerating certain normal healthy bone
marrow tissues. 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
planned clinical trials, product development objectives, and
potential product applications, which involve certain risks and
uncertainties. The forward-looking statements are also identified
through use of the words "should," 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, the effects of
competitive therapies, 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 Cameron
Associates Becky Anderson Kevin McGrath - Institutions Investor
Relations Department Phone: (212) 245-4577 Aastrom Biosciences,
Inc. Alyson Nikulicz - Media Phone: (734) 930-5777 Phone: (212)
554-5464 DATASOURCE: Aastrom Biosciences, Inc. CONTACT: Kris M.
Maly, or Becky Anderson, +1-734-930-5777, both of Aastrom
Biosciences, Inc.; or Kevin McGrath, Institutions, +1-212-245-4577,
or Alyson Nikulicz, Media, +1-212-554-5464, both of Cameron
Associates Web site: http://www.aastrom.com/
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