Gruss E.
Aastrom Biosciences Completes CE Mark Requirements for Third Dendritic Cell Therapy Product -- Expands Aastrom's Cell Production Products Business --
ANN ARBOR, Mich., Aug 21, 2003 /PRNewswire-FirstCall via COMTEX/ -- Aastrom
Biosciences, Inc. (NasdaqSC: ASTM) today announced that it has completed all
requirements to affix the CE Mark on its DCV-II kit in the European Union. This
is the third of the Company's dendritic cell production kits to use the CE Mark.
The DCV-II kit operates on the AastromReplicell(TM) System instrument platform,
and produces peptide-loaded dendritic cells that are being investigated in
clinical trials as therapeutic cancer vaccines. The CE Mark allows Aastrom to
market and sell DCV-II kits in Europe; the kits are available as well in the
United States for clinical research use.
Dendritic cells loaded with specific tumor-associated fragments called peptides
are one of the new approaches currently being clinically investigated to induce
a therapeutic immune response to different forms of cancer. These
tumor-associated peptides include melanoma, colon, breast and prostate cancer-
associated peptides. The AastromReplicell(TM) System and the DCV-II vaccine
production kits facilitate such studies by allowing researchers and
investigators to produce sufficient clinical quantities of dendritic cells in an
automated, closed-system, Good Manufacturing Practices (GMP)-compliant process.
In addition, like the previously released DC-I and DCV-I kits, the DCV-II kit
offers clinical investigators the ability to produce dendritic cells loaded with
a broad array of tumor antigens, and are intended to bring forward a variety of
vaccines based on Aastrom's technology.
"Dendritic cell-based cancer vaccine therapies are being evaluated in a large
number of studies in both Europe and the United States. The DCV-II kit meets the
need for GMP-compliant production of peptide-loaded dendritic cells, which is
one of the newest approaches being evaluated for widespread use of these
vaccines," said R. Douglas Armstrong, Ph.D., President, Chief Executive Officer
and Chairman of Aastrom.
"This market offers a new potential path to near-term revenue for the Company.
We believe that the new DCV-II kit, along with the DC-I and DCV-I kits, can
support the growth of this market, as well as improve the clinical success of
these innovative cancer vaccine approaches," concluded Armstrong.
Other CE Marked Aastrom products include: the AastromReplicell(TM) System
("System"), the DC-I kit, intended for the production of dendritic cells for use
in fusion or transfection cell-based cancer vaccines and the DCV-I kit, intended
for the production of complete antigen-loaded dendritic cell vaccines. Aastrom
has installed the System for several of its products in fifteen sites in Europe
and the United States; sites evaluating the Company's dendritic cell production
products include: Stanford University and Duke University in the United States,
and University of Mannheim and University of Erlangen in Germany.
The Company markets and sells its Cell Production Products in Europe through its
wholly owned subsidiary, Zellera AG. In the United States, for more information
about Aastrom's Cell Production Products, contact Ron Dudek, Director Sales and
Marketing, at 734-930-5768.
About Zellera AG
Zellera AG is a wholly owned subsidiary of Aastrom Biosciences, Inc., located in
Berlin, Germany. Zellera serves as the sales and marketing operational base for
Aastrom's products in Europe. For more information, visit Zellera's website at
www.zellera.de, or contact Holger Beckmann, Managing Director, at
011-49-30-2065-9165.
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 product development objectives, potential product
applications, product results, product revenue generation and potential
advantages of the AastromReplicell(TM) System, which involve certain risks and
uncertainties. The forward-looking statements are also identified through use of
the words "intended," "believe," "can," "potential," 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, the results of product marketing
activities conducted by third parties, actions taken by marketing partners and
competitors, 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.
