Aastrom Biosciences Achieves U.S. Bone Fracture Clinical Milestone
30 June 2006 - 7:05AM
PR Newswire (US)
-- TRC Cell Product Treatment Completed for All Patients -- ANN
ARBOR, Mich., June 29 /PRNewswire-FirstCall/ -- Aastrom
Biosciences, Inc. (NASDAQ:ASTM) announced today that it has
completed the last patient accrual and treatment in its U.S. Phase
I/II multi-center long bone fracture trial. Completion of the cell
therapy phase for all 36 patients enrolled in this trial represents
a key milestone that supports Aastrom's business model to use its
cell-based Tissue Repair Cells (TRCs) for tissue regeneration.
(Logo: http://www.newscom.com/cgi-bin/prnh/20060302/NETH028LOGO )
"We are pleased that all patients have completed the surgical phase
of this clinical trial," said Janet M. Hock, B.D.S., Ph.D., Vice
President Global Research and Chief Scientific Officer of Aastrom.
"This is an important company and clinical milestone that sets us
well on our way in the evaluation of how well TRCs safely
regenerate bone. If these data support our early feasibility study
data, our TRC therapy should provide a new solution to a currently
unmet need in the world of orthopedic medicine." This announcement
follows positive interim data presented earlier this year by
Principal Investigator, Matthew L. Jimenez, M.D., of the Illinois
Bone & Joint Institute. Dr. Jimenez presented results from his
early clinical experience with the first seven patients treated for
recalcitrant long bone non-union fractures with Aastrom's TRCs. All
patients appear to have demonstrated bone healing, and returned to
weight bearing mobility by 6 months. The U.S. Phase I/II clinical
trial is evaluating the use of TRCs -- a mixture of stem, stromal
and progenitor cells derived from the patient's bone marrow -- in
the treatment of severe fractures that have failed prior treatment
interventions. All patients treated in this trial will be followed
for a total of twelve months post-surgery, with interim data
collected at the six month endpoint. It is expected that additional
interim data will be disclosed by the end of September 2006. The
interim results reported to date from this U.S. trial complement
observations previously disclosed in Aastrom's Spanish feasibility
study, showing positive bone regeneration with no TRC-related
adverse events in all patient treatments. Based on data provided to
the Spanish Drug Agency, Aastrom was granted permission to commence
another severe non-union bone fracture trial in Spain, and is
actively enrolling up to 10 patients at this clinical site. About
Aastrom Biosciences, Inc. Aastrom Biosciences, Inc. (NASDAQ:ASTM)
is developing products for the repair or regeneration of multiple
human tissues, based on its proprietary Tissue Repair Cell (TRC)
adult stem cell technology. Aastrom's TRC products contain large
numbers of stromal, stem and progenitor cells that are produced
from a small amount of bone marrow cells originating from the
patient. The AastromReplicell(R) System, an industry-unique
automated cell product manufacturing platform, was developed for
the production of standardized, patient-specific TRC products. TRC
products have been used safely in humans as a substitute for bone
marrow stem cells, and are currently in clinical trials for bone
grafting (long bone fractures and spine fusion) and blood vessel
regeneration (diabetic limb ischemia) applications. The Company has
recently reported positive interim clinical trial results for its
TRCs demonstrating both the clinical safety and ability of TRCs to
induce healthy new tissue growth (long bone fractures and jaw bone
reconstruction). Most recently, the Company's proprietary TRCs
received an Orphan Drug Designation from the U.S. Food and Drug
Administration (FDA) for use in the treatment of osteonecrosis at
the hip. 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, potential
advantages of TRCs, and potential product applications, which
involve certain risks and uncertainties. The forward-looking
statements are also identified through use of the words "expected,"
"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 potential patient accrual difficulties, 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 Cameron
Associates Investor Relations Department Kevin McGrath Aastrom
Biosciences, Inc. Phone: (212) 245-4577 Phone: (734) 930-5777
http://www.newscom.com/cgi-bin/prnh/20060302/NETH028LOGO
http://photoarchive.ap.org/ DATASOURCE: Aastrom Biosciences, Inc.
CONTACT: Kris M. Maly, Investor Relations Department of Aastrom
Biosciences, Inc., Phone: +1-734-930-5777; or Kevin McGrath of
Cameron Associates, Phone: +1-212-245-4577 Web site:
http://www.aastrom.com/
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