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Aastrom Biosciences Receives NIH Grant for Dendritic Cell Vaccine Research
MONDAY, SEPTEMBER 15, 2003 8:01 AM
- PR Newswire

ANN ARBOR, Mich., Sep 15, 2003 /PRNewswire-FirstCall via COMTEX/ -- Aastrom Biosciences, Inc. (NasdaqSC: ASTM) today announced it has received a Small Business Innovation Research Phase I grant from the National Institutes of Health (NIH) to demonstrate the feasibility of utilizing the AastromReplicell(TM) System ("System") for the production of completed dendritic cell-based vaccines for the immunotherapy of ovarian cancer, the leading cause of gynecological cancer-related deaths in women. This constitutes the fourth NIH grant awarded to the Company in the past two quarters.

Recent studies have shown that dendritic cells produced and exposed to cancer molecules (antigens) in culture ex vivo have induced clinically significant immune responses against malignant diseases. Current methods of cell production utilize traditional laboratory cell culture approaches that present difficulties in producing large-scale quantities of complex dendritic cell vaccines. This study will evaluate and demonstrate the feasibility of using Aastrom`s System, a GMP-compliant, integrated, fully-automated system, to produce sufficient clinical quantities of antigen-loaded dendritic cells to perform a complete immunotherapy treatment in patients with ovarian cancer.

Dr. Douglas M. Smith, Immunotherapy Program Leader at Aastrom, is the principal investigator for the six-month study, funded at $101,262 by the NIH`s National Cancer Institute, which will be conducted at the Company`s laboratories in Ann Arbor, MI. In related activities to this preclinical study for an ovarian cancer dendritic cell vaccine, Aastrom is preparing to begin dendritic cell clinical studies in collaboration with Stanford University for multiple myeloma cancer and with Duke University for colorectal cancer.

"We are very interested in determining the role Aastrom`s technology can have in bringing new cell-based cancer vaccines forward," said R. Douglas Armstrong, Ph.D., President and Chief Executive Officer of Aastrom. "This new NIH grant supports that mission by validating our belief in the potential of dendritic cell vaccines, and the necessity for effective large-scale cell production solutions."

The successful completion of this Phase I study should lead to a Phase II program designed to optimize and fully automate the antigen-loading process, and clinically evaluate the completed patient-specific dendritic cell vaccine in human clinical trials.

About Aastrom`s Immunotherapy Program

Aastrom`s Immunotherapy Program is focused on the development, evaluation and commercial implementation of single-pass medium perfusion and closed system automation for widespread and reproducible production of clinical quantities of an array of different dendritic cell-based vaccines for patient therapy. Dendritic cell antigen loading strategies may include simple peptides, complex protein antigens, nucleic acids, apoptotic tumor cells, tumor lysates and viral vectors. Recently, the Company received CE marking in Europe of its third dendritic cell product, designated DCV-II, for the automated GMP-compliant production and peptide-epitope priming of dendritic cells in the AastromReplicell(TM) System. Peptide antigens are under broad evaluation and clinical application as well-defined molecular targets for the immune system against infectious diseases and cancer. Additional strategies for antigen-independent or antigen-driven ex vivo expansion of T-lymphocytes as potent mediators of cellular immunity against cancer and infectious diseases are under preclinical testing and development using Aastrom`s proprietary technologies.

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

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Da haben am Freitag sicherlich schon einige was gewusst

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The Wall Street Analyst Forum -- Drugs & Biotechnology Conference
THURSDAY, SEPTEMBER 11, 2003 3:30 PM
- PR Newswire

ANN ARBOR, Mich., Sep 11, 2003 /PRNewswire-FirstCall via COMTEX/ -- Aastrom Biosciences (NasdaqSC: ASTM) to present at Wall Street Analyst Forum.


R. Douglas Armstrong, Ph.D., President and CEO
Aastrom Biosciences, Inc.
The Cell Therapy Company
Website: www.aastrom.com

-- Aastrom -- capturing the therapeutic potential of bone marrow stem
cells

-- FDA approval of IND application to initiate multi-center trials for
bone grafting product

-- Strategic alliance with MTF -- the leading provider of orthopedic
matrices

-- Multiple grants from the NIH to optimize proprietary technology and
products related to tissue generation

-- Proven clinical success in regenerating skeletal bone tissue in patient
with potentially fatal, genetic skeletal disease

-- Significant collaborations signed with prestigious organizations and
universities

LIVE PRESENTATION & WEBCAST

DATE: Monday, September 15, 2003 at 9:00 am (EDT)
[Recorded webcast available for 30 days after conference]

Choose Aastrom Biosciences` Presentation by linking to:

http://www.firstcallevents.com/service/5580_Agenda1.html


SOURCE Aastrom Biosciences