Aastrom Biosciences Inc 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 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.
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.