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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

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	Item 5. Other Events.
	Item 7. Financial Statements and Exhibits.
SIGNATURES
EXHIBIT INDEX
EXHIBIT 99.1

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Item 5. Other Events.

On January 14, 2004, Aastrom Biosciences issued a press release relating to the initiation of a clinical trial, in collaboration with investigators at the Illinois Bone and Joint Foundation, to evaluate the Company’s bone generation Tissue Repair Cell stem cell product for the treatment of tibial non-union fractures. The press release is attached as Exhibit 99.1.

Item 7. Financial Statements and Exhibits.

SIGNATURES

     Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

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EXHIBIT INDEX

 

                                                                    EXHIBIT 99.1

Aastrom Biosciences Inc.
Located at: Domino's Farms, Lobby L
P.O. Box 376
Ann Arbor, Michigan 48106
Ph: 734-930-5555
Fax: 734-665-0485


FOR IMMEDIATE RELEASE

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

                          AASTROM BIOSCIENCES INITIATES
                   BONE GRAFT CLINICAL TRIAL AT LEAD U.S. SITE

   EVALUATION OF STEM CELL PRODUCT FOR LEG FRACTURE HEALING BEGINS IN CHICAGO

ANN ARBOR, MICHIGAN, JANUARY 14, 2004 -- Aastrom Biosciences, Inc. (NasdaqSC:
ASTM) today announced that its U.S. clinical trial of the Company's bone
generation Tissue Repair Cell (TRC) stem cell product has been initiated at its
lead clinical trial site in Chicago, IL. This study follows the previously
announced FDA approval of the Company's Investigational New Drug (IND)
application which allows Aastrom's TRCs to be used at up to three centers for
the treatment of tibial non-union fractures. The Principal Investigator in the
trial is Matthew L. Jimenez, M.D., of the Illinois Bone & Joint Institute. The
clinical trial will be conducted at Lutheran General Hospital in Park Ridge, IL.

This bone graft trial represents a key milestone that supports Aastrom's focus
on the use of its stem cell-based TRCs for tissue generation. Laboratory
evaluations of Aastrom's TRCs indicate that they contain a large number of
bone-forming cells. In addition, these cells have been proven safe when
administered to patients in previous clinical trials. Aastrom's new clinical
trial will evaluate the use of these cells when applied at the fracture site to
generate bone in patients with severe types of leg fractures. Pending the
successful completion of the trial, TRCs could lead to a viable alternative to
the current, highly invasive standard of treatment, for use in the multi-million
dollar bone graft market.

"The launch of this bone generation trial brings Aastrom into the active
clinical trial stage for our TRC stem cell product - clearly an important
accomplishment for the Company that points to the leading strategic position we
have attained in the cell therapeutics industry," said R. Douglas Armstrong,
Ph.D., President, Chief Executive Officer and Chairman of Aastrom. "Progress is
achieved one step at a time, and we intend to pursue additional clinical studies
both here and in Europe, to determine the ability of TRCs to safely generate
bone in patients and thus provide a valuable new tool in orthopedic medicine."

Up to three centers will be included in the current trial, and as many as 20
patients will be recruited who have either long-term (a minimum of 8 months)
non-healing tibial leg fractures, or tibial non-union fractures that are severe
enough to require a bone graft to aid repair. Aastrom expects to initiate the
further evaluation of its TRCs at other centers in both the U.S. and Europe.

ABOUT AASTROM'S TRCS

TRCs are Aastrom's proprietary stem and progenitor cells, produced from small
samples of a patient's own bone marrow (autologous cells). TRCs are enriched for
early stage stem and progenitor cells that can form bone and other tissues, and
have been safely used in over 150 patients to generate normal bone marrow, as
well as immune system cells. In addition, TRCs were successfully used in a
compassionate use case to generate systemic bone in a patient with the genetic
bone disease, infantile hypophosphatasia.

                                     -more-

                                                     Aastrom-OCG Trial - Chicago
                                                                January 14, 2004
                                                                          Page 2

ABOUT BONE GRAFTING

Bone grafting is used to treat over 1 million patients annually in the U.S. and
Europe, in procedures including the repair of major fractures such as tibial
non-union fractures, and various types of vertebral fusion. The current standard
approach to obtain bone graft material involves chiseling out bone and marrow
from a patient's hip. This invasive "autograft" process can result in
substantial acute and chronic pain, discomfort, and mobility problems.

Current bone graft substitute products lack the cells needed to promote
effective bone growth, and are therefore a less effective alternative. TRCs have
substantially more bone-forming cells compared to native bone marrow, as has
been demonstrated by lab and animal models testing bone generation. TRCs mixed
with a matrix (allograft) should provide the components to form bone, and may
provide an effective alternative to autograft. In the U.S. trial for tibial
non-union fractures, Aastrom's TRCs will be mixed with commercial allograft
matrix provided by the Musculoskeletal Transplant Foundation (MTF), Aastrom's
collaboration partner for this trial.

ABOUT AASTROM BIOSCIENCES, INC.

Aastrom Biosciences, Inc. (NasdaqSC: ASTM) is a late-stage development company
focused on human cell-based therapies. The AastromReplicell(TM) System - a
patented, integrated system of instrumentation and single-use consumable kits
for the production of patient-specific cells - is the Company's core technology
for its Prescription Cell Products (PCP) business and its Cell Production
Products (CPP) business. The principal focus of the PCP business is the repair
or regeneration of tissue intended for large markets such as bone grafting,
vascular systems and severe osteoporosis. The CPP business markets the
AastromReplicell(TM) System to researchers and companies for their production of
cells for clinical trials. These two businesses are intended to enable Aastrom
to generate multiple paths to revenue. The initial commercial phase of the CPP
business for dendritic cell production products is underway in Europe and the
United States. For more information, visit Aastrom's website at www.aastrom.com.

THIS DOCUMENT CONTAINS FORWARD-LOOKING STATEMENTS, INCLUDING WITHOUT LIMITATION,
STATEMENTS CONCERNING PLANNED CLINICAL TRIALS, PRODUCT DEVELOPMENT OBJECTIVES,
POTENTIAL PRODUCT APPLICATIONS, AND POTENTIAL ADVANTAGES OF THE
AASTROMREPLICELL(TM) SYSTEM AND RELATED CELLS, WHICH INVOLVE CERTAIN RISKS AND
UNCERTAINTIES. THE FORWARD-LOOKING STATEMENTS ARE ALSO IDENTIFIED THROUGH USE OF
THE WORDS "INTENDED," "EXPECTS," "MAY," "SHOULD," "COULD," "CAN," 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 FUTURE CLINICAL TRIAL RESULTS, REGULATORY APPROVAL
REQUIREMENTS, THE AVAILABILITY OF 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.

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