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Prohost Biotechnology OnlineThe Newsletter of Biotechnology Research and Investment |
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AASTROM AND DENDRITIC CELLSDate: 07 Aug 2000 CommentsAastrom Biosciences, Inc. (Nasdaq: ASTM) announced today that the Company has received a grant from the National Cancer Institute, providing research funding of up to $756,000 over a two-year period. This Phase II, Small Business Innovation and Research (SBIR) grant from the National Institutes of Health (NIH) will support development of the AastromReplicell™ System for clinical production of human dendritic cells. * Dendritic cells are antigen presenting cells, a type of blood cell that have the ability to turn antigens into immunogens to stimulate an immune response against specific targets. Many firms are using them in cancer and treatments, especially, vaccines. Aastrom will collaborate with Duke University Medical Center on this grant. "Clinical-scale production of human dendritic cells is a major market opportunity for the Company," said R. Douglas Armstrong, Ph.D., President and CEO of Aastrom Biosciences. "In addition to receiving a significant level of funding from the NIH, we have also established a new collaboration with Duke University Medical Center to advance our dendritic cell program into clinical use. We plan to establish additional collaborations and relationships with other major international clinical centers in the coming months." -------------------------------------------------------------------------------------------------------------------------------- In a recent study published in the March 2000 issue of Nature Medicine, researchers at three leading German medical centers reported positive results of a new dendritic cell-based therapy. 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 cancer. Of the patients treated in the study, 41% (7 of 17) exhibited remission responses, four of which were complete tumor remissions. These results indicate a major new treatment modality against renal cell carcinoma. Further, additional clinical trials are currently underway at leading cancer centers to demonstrate the effectiveness of this new therapeutic approach in multiple cancer types. --------------------------------------------------------------------------------------------------------------------------------- Dendritic cell therapies require culture and activation of the dendritic cells outside of the patient (ex vivo). In these initial trials, production of the dendritic cells was performed using manual research laboratory equipment, open cell culture processes and specialized personnel. The Company believes that such processing steps introduce the potential for contamination and procedure variability that will ultimately limit the ability of these procedures to become generally available medical therapies. Further, in order for these procedures to receive regulatory approval and to be used in standard medical practice, Aastrom believes that they must ideally be standardized and implemented through sterilely closed, automated systems. The AastromReplicell™ System is designed to address these key needs by enabling automated therapeutic dendritic cell production through a standardized product format. This Phase II grant is an extension of a grant previously awarded to the Company and demonstrates the Company's objective to access new market opportunities through collaboration. The Phase I program demonstrated that Aastrom's novel single-pass medium profusion provided by the AastromReplicel™ System produced highly functional dendritic cell populations as compared to other static cell culture techniques. The primary objective of the research under the Phase II grants will be to optimize conditions for effective dendritic cell production. The grant funding will also support development of a new therapy kit for an automated cell production process in the AastromReplicell™ System. A portion of the research activities under the grant will be done in collaboration with Duke University Medical Center, which is currently a clinical site evaluating the use of the AastromReplicell™ System and the CB-I Therapy Kit for the production of cord blood-derived cells used in cancer therapy. The AastromReplicell(TM) System consists of an instrumentation platform designed to operate a family of patient-specific cell therapy kits for a broad range of cell therapy applications. The AastromReplicell™ System instrumentation platform and disposable therapy-specific kits comprise the first integrated system designed to produce therapeutic quantities of cells in a clinical setting. Aastrom is pioneering the development of proprietary clinical systems including the AastromReplicell™ System, a first of its kind product, to enable physicians and patients greater accessibility to cells used for therapy. Aastrom has received patents covering methods and devices for the ex vivo production of human stem and other types of cells, as well as for the genetic modification of stem cells. The AastromReplicell™ System is under development, and is not available for sale at this time in the U.S., except for research and investigational use.
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