Aastrom Biosciences Receives Manufacturing License at European Pilot Facility for Production of Proprietary Bone Marrow Stem Ce
10 May 2006 - 9:15PM
PR Newswire (US)
- German Facility Collaboration With Fraunhofer Institute to
Provide Product for European Clinical Use - ANN ARBOR, Mich., May
10 /PRNewswire-FirstCall/ -- Aastrom Biosciences, Inc.
(NASDAQ:ASTM) announced today that it has received a human
pharmaceuticals manufacturing license, through its wholly owned
subsidiary, for the production of the Company's Tissue Repair Cell
(TRC) products. This is the first manufacturing license issued to
Aastrom in the European Union (EU), and it enables Aastrom to
produce its human cell and tissue products for clinical use in
compliance with EU regulations. The newly licensed manufacturing
facility was established as a collaboration at the Fraunhofer
Institute for Interfacial Engineering and Biotechnology in
Stuttgart, Germany. (Logo:
http://www.newscom.com/cgi-bin/prnh/20060302/NETH028LOGO ) Aastrom
is currently involved in several clinical trials that use TRC-
based products for tissue regeneration. The new manufacturing site
will be used to expand these studies, and will serve as a pilot
facility for centralized manufacturing that is a requirement of the
Company's commercialization strategy. The TRC manufacturing
process, including Aastrom's patented AastromReplicell(R) System,
has been installed and validated at the German site, in compliance
with EU Good Manufacturing Practices (EU-GMP). "Our successful
establishment of a licensed centralized manufacturing facility to
produce Aastrom's TRC products for tissue regeneration is an
important operational milestone in our commercial business
strategy," said R. Douglas Armstrong, Ph.D., Chief Executive
Officer and Chairman of Aastrom. "This authorization provides the
Company with a manufacturing capability that can be used for all of
our TRC products in clinical development, and demonstrates that
Aastrom is successfully advancing autologous stem cell products
from research toward commercialization." This licensed European
facility incorporates the Company's proprietary technologies for
automated, process-controlled production of reliable,
patient-specific cell-based products, overcoming what has been a
hurdle in the cell-based product industry. Traditional
pharmaceuticals are typically produced in a single lot, and used
for many thousands of patients; this manufacturing model cannot be
used for autologous cell/tissue products. Each autologous TRC
product is manufactured for a specific patient. Aastrom has
pioneered a scalable cell/tissue manufacturing process that aids
regulatory compliance; traditional cell culture production
approaches are manual and lack the advantages of Aastrom's
technology. The receipt of a human pharmaceutical license for the
TRC manufacturing operation is an important validation of Aastrom's
technology and is a key component of the Company's business model.
About Fraunhofer IGB The Fraunhofer Institute for Interfacial
Engineering and Biotechnology IGB (Fraunhofer IGB) offers research
and development solutions in the fields of health, environment and
technology. Their competences are comprised of interfacial
engineering and membrane technology as well as biotechnology, cell
biology and bioprocess engineering. Fraunhofer IGB offers solutions
from market analysis through research and development, through the
finished product. Fraunhofer IGB is one of many
Fraunhofer-Gesellschaft institutes, an organization that partners
with private and public companies to promote innovative applied
research in all fields of the engineering sciences to facilitate
commercialization throughout Germany, as well as other European
countries. About Tissue Repair Cell Manufacturing Tissue Repair
Cells (TRCs) are Aastrom's proprietary mixture of large numbers of
adult stromal, stem and progenitor cells derived from bone marrow.
TRCs are the key technological component of Aastrom's tissue
regeneration products that are produced using patented single-pass
perfusion technology. 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(R) 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 tissues.
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 "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 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, Aastrom
Biosciences, +1-734-930-5777; Kevin McGrath of Cameron Associates,
+1-212-245-4577, for Aastrom Web site: http://www.aastrom.com/
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