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2004 JAN 7 - (NewsRx.com & NewsRx.net) -- Aastrom Biosciences, Inc., (ASTM) announced the initiation of a phase I clinical trial in collaboration with investigators at Duke University Medical Center (Duke).
The clinical trial will evaluate a dendritic cell-based vaccine as a new treatment for an assortment of gastrointestinal (GI) system cancers, including colorectal, stomach and pancreatic cancers. The trial protocol proposes to examine the safety, feasibility, immune outcome and clinical efficacy of a vaccination that is produced by loading tumor-associated peptide antigens onto a patient's blood-derived dendritic cells produced using Aastrom's DCV-II dendritic cell vaccine production kit and the AastromReplicell System.
This trial is funded by a National Institutes of Health (NIH) grant awarded to Aastrom and is being conducted under a U.S. Food and Drug Administration (FDA) Investigational New Drug application that was submitted by Duke. The protocol for the trial is approved for accrual of up to 12 patients, and is expected to take up to 24 months to complete. In addition to determining safety and certain immune system and tumor endpoints, the trial will evaluate the number of vaccinations needed to elicit potent immunity against carcinoembryonic antigen (CEA), a tumor-specific protein. Aastrom's System is expected to produce sufficient, clinical amounts of patient-derived dendritic cells to allow each patient to receive multiple vaccinations.
"It is our strategy to initiate important collaborations, such as this one with Duke, to provide access to Aastrom's unique dendritic cell vaccine production and cells, which is intended to lead to new therapeutic products for the company. If a patient's immunity can be successfully induced, this approach to cancer vaccine treatment could offer tremendous benefits to a large number of cancer patients," said R. Douglas Armstrong, PhD, president, CEO and chairman of Aastrom.
"Furthermore, Aastrom's DCV-II product could provide a reliable vaccine ...