Aastrom Biosciences Executes Evalaution Agreements With Leading German Dendritic Cell Vaccine Centers

- DC-I Dendritic Cell Product Advances Toward U.S. and European Clinical

Markets -



Apr 19, 2001, 01:00 ET from Aastrom Biosciences, Inc.

    ANN ARBOR, Mich., April 19 /PRNewswire/ -- Aastrom Biosciences, Inc.
 (Nasdaq: ASTM) announced today that it has entered into agreements with the
 Universitatsklinikum Charite, Berlin, Germany, and the University of
 Gottingen, Gottingen, Germany to begin European evaluation of its DC-I
 dendritic cell product for use in cancer vaccines.  These evaluation
 agreements follow recent announcements that U.S. product testing has been
 initiated at the Barbara Ann Karmanos Center at Wayne State University,
 Detroit, MI, and Beth Israel Deaconess Medical Center (BIDMC), Boston, MA, a
 Harvard Medical School teaching hospital.
     "As dendritic cell-based vaccines are being broadly investigated as a
 powerful new treatment modality for cancer, Aastrom has aggressively moved the
 DC-I product forward to meet this new market opportunity," stated R. Douglas
 Armstrong, Ph.D., President and CEO of Aastrom. "The rapid progress of our
 dendritic cell product program underscores our commitment to positioning
 Aastrom as a leading provider of cell-based therapeutics.  These German sites
 have been important pioneers in the development of novel dendritic cell
 vaccine approaches to cancer treatment, and are ideally suited to provide us
 with initial feedback of our new product as future customers.  Following this
 evaluation period, we plan to apply for CE Mark approval necessary for
 European marketing, and to then market the DC-I cell product to both U.S. and
 European research centers that are developing dendritic cell-based cancer
 vaccines."
     In a study published in the March 2000 issue of Nature Medicine,
 researchers at these two medical centers, along with collaborators at the
 Universitat of Tubingen, reported positive results with dendritic cell-based
 therapies.  In this study, renal cell carcinoma patients were treated with
 dendritic cells that had been produced outside of the body, and then fused
 with tumor cells collected from the patient.  The modified dendritic cells,
 once injected into the patient, act as "educator" cells to trigger an immune
 response against the patient's cancer.  Of the patients treated in the study,
 41% (7 of 17) exhibited remission responses, four of which were complete tumor
 remissions.
      Additional research is currently underway at these and other leading
 cancer centers to investigate the effectiveness of this new therapeutic
 approach in multiple cancer types including renal cell carcinoma, melanoma,
 and breast cancer.  The American Cancer Society estimates that these cancers
 affect more than 250,000 new patients annually. Critical to this approach is a
 high quality dendritic cell source, produced in a consistent, reliable and
 cost effective manner and in sufficient quantities for therapeutic effect.
 Aastrom's DC-I dendritic cell product is intended to meet these key objectives
 and to serve as a base dendritic cell for these types of vaccines.
     Aastrom's DC-I dendritic cell product and the AastromReplicell(TM) System
 represent a significant advancement for dendritic cell-based therapies.  To
 date, the production of dendritic cells for clinical use has been completed
 with complex, manual cell culture approaches, limited to small scale
 situations and effectively practiced by only a few research institutions.
 Typically, manual cell culturing is slow and can result in poor outcome
 reliability and difficulties in complying with Good Manufacturing Practices
 (GMP).  Aastrom's DC-I product is intended to address these important issues
 with superior outcome reliability and a better cell product.  It is expected
 that such improvements will result in stronger, more effective dendritic cell
 therapies.
 
     Aastrom is pioneering the development of proprietary cell therapeutics and
 cell products based on its dual-technology platforms: patented "single-pass
 perfusion" providing cells with enhanced biological function, and patented
 GMP-compliant system automation facilitating the delivery of cells for
 therapeutic use into medical practice.  These technologies are integrated into
 the AastromReplicell(TM) System that is designed to uniquely standardize and
 automate the processes involved in producing high quality therapeutic cells.
 Aastrom is developing the DC-I dendritic cell product for use in the rapidly
 emerging cancer vaccine market and the OC-I bone progenitor cell product for
 the treatment of degenerative bone diseases such as osteoporosis.  The
 AastromReplicell(TM) System, the SC-I bone marrow stem cell product and the
 CB-I cord blood cell product have received CE Mark approval necessary for
 European marketing and are in late-stage U.S. clinical trials.  These products
 are not available for sale at this time in the U.S., except for research or
 investigational use.
     Please visit our website at http://www.aastrom.com
 
     This document contains forward-looking statements, including without
 limitation, statements concerning intended areas of research, product
 development objectives, commercialization plans, potential product
 applications 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 "expect," "intend," "plan," 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 the results obtained from research
 being conducted by other organizations, clinical trial and development
 activities, regulatory approval requirements, the availability of resources,
 competitive developments 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-10K and other filings with the
 Securities and Exchange Commission.
 
     Contact Todd E. Simpson, VP Finance & Administration, CFO of Aastrom
 Biosciences, Inc., 734-930-5777; or media - Hala Bashir, ext. 356, or
 investors - David Walsey, ext. 230 of Noonan-Russo Communications, Inc.,
 212-696-4455
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X76387366
 
 

SOURCE Aastrom Biosciences, Inc.
    ANN ARBOR, Mich., April 19 /PRNewswire/ -- Aastrom Biosciences, Inc.
 (Nasdaq: ASTM) announced today that it has entered into agreements with the
 Universitatsklinikum Charite, Berlin, Germany, and the University of
 Gottingen, Gottingen, Germany to begin European evaluation of its DC-I
 dendritic cell product for use in cancer vaccines.  These evaluation
 agreements follow recent announcements that U.S. product testing has been
 initiated at the Barbara Ann Karmanos Center at Wayne State University,
 Detroit, MI, and Beth Israel Deaconess Medical Center (BIDMC), Boston, MA, a
 Harvard Medical School teaching hospital.
     "As dendritic cell-based vaccines are being broadly investigated as a
 powerful new treatment modality for cancer, Aastrom has aggressively moved the
 DC-I product forward to meet this new market opportunity," stated R. Douglas
 Armstrong, Ph.D., President and CEO of Aastrom. "The rapid progress of our
 dendritic cell product program underscores our commitment to positioning
 Aastrom as a leading provider of cell-based therapeutics.  These German sites
 have been important pioneers in the development of novel dendritic cell
 vaccine approaches to cancer treatment, and are ideally suited to provide us
 with initial feedback of our new product as future customers.  Following this
 evaluation period, we plan to apply for CE Mark approval necessary for
 European marketing, and to then market the DC-I cell product to both U.S. and
 European research centers that are developing dendritic cell-based cancer
 vaccines."
     In a study published in the March 2000 issue of Nature Medicine,
 researchers at these two medical centers, along with collaborators at the
 Universitat of Tubingen, reported positive results with dendritic cell-based
 therapies.  In this study, renal cell carcinoma patients were treated with
 dendritic cells that had been produced outside of the body, and then fused
 with tumor cells collected from the patient.  The modified dendritic cells,
 once injected into the patient, act as "educator" cells to trigger an immune
 response against the patient's cancer.  Of the patients treated in the study,
 41% (7 of 17) exhibited remission responses, four of which were complete tumor
 remissions.
      Additional research is currently underway at these and other leading
 cancer centers to investigate the effectiveness of this new therapeutic
 approach in multiple cancer types including renal cell carcinoma, melanoma,
 and breast cancer.  The American Cancer Society estimates that these cancers
 affect more than 250,000 new patients annually. Critical to this approach is a
 high quality dendritic cell source, produced in a consistent, reliable and
 cost effective manner and in sufficient quantities for therapeutic effect.
 Aastrom's DC-I dendritic cell product is intended to meet these key objectives
 and to serve as a base dendritic cell for these types of vaccines.
     Aastrom's DC-I dendritic cell product and the AastromReplicell(TM) System
 represent a significant advancement for dendritic cell-based therapies.  To
 date, the production of dendritic cells for clinical use has been completed
 with complex, manual cell culture approaches, limited to small scale
 situations and effectively practiced by only a few research institutions.
 Typically, manual cell culturing is slow and can result in poor outcome
 reliability and difficulties in complying with Good Manufacturing Practices
 (GMP).  Aastrom's DC-I product is intended to address these important issues
 with superior outcome reliability and a better cell product.  It is expected
 that such improvements will result in stronger, more effective dendritic cell
 therapies.
 
     Aastrom is pioneering the development of proprietary cell therapeutics and
 cell products based on its dual-technology platforms: patented "single-pass
 perfusion" providing cells with enhanced biological function, and patented
 GMP-compliant system automation facilitating the delivery of cells for
 therapeutic use into medical practice.  These technologies are integrated into
 the AastromReplicell(TM) System that is designed to uniquely standardize and
 automate the processes involved in producing high quality therapeutic cells.
 Aastrom is developing the DC-I dendritic cell product for use in the rapidly
 emerging cancer vaccine market and the OC-I bone progenitor cell product for
 the treatment of degenerative bone diseases such as osteoporosis.  The
 AastromReplicell(TM) System, the SC-I bone marrow stem cell product and the
 CB-I cord blood cell product have received CE Mark approval necessary for
 European marketing and are in late-stage U.S. clinical trials.  These products
 are not available for sale at this time in the U.S., except for research or
 investigational use.
     Please visit our website at http://www.aastrom.com
 
     This document contains forward-looking statements, including without
 limitation, statements concerning intended areas of research, product
 development objectives, commercialization plans, potential product
 applications 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 "expect," "intend," "plan," 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 the results obtained from research
 being conducted by other organizations, clinical trial and development
 activities, regulatory approval requirements, the availability of resources,
 competitive developments 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-10K and other filings with the
 Securities and Exchange Commission.
 
     Contact Todd E. Simpson, VP Finance & Administration, CFO of Aastrom
 Biosciences, Inc., 734-930-5777; or media - Hala Bashir, ext. 356, or
 investors - David Walsey, ext. 230 of Noonan-Russo Communications, Inc.,
 212-696-4455
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X76387366
 
 SOURCE  Aastrom Biosciences, Inc.