Aastrom Biosciences and Loyola University Announce First Successful Transplants of Ex Vivo Produced Stem Cells in Cancer Patients
- Positive Clinical Results Published in March Issue of Blood -
MAYWOOD, Ill. and ANN ARBOR, Mich., March 15 /PRNewswire/ -- Loyola University Medical Center and Aastrom Biosciences, Inc. (Nasdaq: ASTM - news) announced today the publication of positive clinical results describing the first ever successful transplants of ex vivo-produced (produced outside of the body) human stem cells in breast cancer patients. The human stem cells used for transplantation were produced using the AastromReplicell(TM) Cell Production System and SC-I Therapy Kit. These results, which appear in March 15, 2000 issue of the journal Blood, report clinical trial results and long-term follow-up of ex vivo produced stem cells used for transplantation.
``Typical stem cell collection methods including surgical bone marrow harvest or peripheral blood stem cell (PBSC) mobilization and blood apheresis, can be invasive to the patient, expensive to perform and may result in the unintended collection, and ultimately, re-transplantation, of tumor cells,' said Patrick J. Stiff, MD, Director of the Bone Marrow Transplantation Program at Loyola University Medical Center. ``The results from this study represent a significant advancement in stem cell transplantation as they demonstrate that transplantation of ex vivo produced stem cells can effectively restore a patient's blood and immune system as well as offer a procedure that may reduce or eliminate the re-infusion of contaminating tumor cells,' Dr. Stiff concluded.
Cancer patients often undergo chemotherapy or radiation therapy in an attempt to eradicate cancer cells. High dose therapies however, can damage or destroy the patient's bone marrow and their blood and immune system function. Stem cell transplantation is used following such treatments to facilitate the restoration of healthy bone marrow and to reestablish normal blood and immune system function. The AastromReplicell(TM) System, currently in Phase III-pivotal clinical evaluation, is a first of its kind product to enable physicians to produce cells for use in therapeutic procedures.
Clinical Trial Design
This Phase II clinical trial evaluated the safety and efficacy of stem cell transplants using human stem cells produced ex vivo with the AastromReplicell(TM) System. This study included 19 patients with Stage II-IV (12 of whom had Stage II/IIIa) breast cancer who have undergone ablative chemotherapy to treat their cancer. Patients received transplants of stem cells produced from a small starting volume of autologous bone marrow in the AastromReplicell(TM) System using the SC-I Therapy Kit. The study was intended to evaluate whether stem cells produced ex vivo in the AastromReplicell(TM) System could be used by themselves to restore blood and immune system function following aggressive chemotherapy and evaluated the time to engraftment of the patients' key infection fighting white blood cells (neutrophils) and blood-clotting cells (platelets) to control bleeding.
Clinical Trial Results
Clinical results showed that recovery of the patients' neutrophils and platelets exhibited recoveries that were similar to results seen with traditional bone marrow transplants. The median times to absolute neutrophil count (ANC) and platelet engraftment were 16 and 24 days, respectively. Results also showed no late engraftment failures, even following subsequent chemotherapy or radiation therapy. The Company also reported, at the Annual Meeting of the American Society of Hematology in December 1999, that of the 12 patients in this study that had stage II/IIIa breast cancer, 92 percent (11 patients) remained progression-free at a median time since transplant of 27 months. This suggested a better than expected progression-free survival for the patients as compared to that seen with standard PBSC transplants at Loyola.
In addition to these clinical results, Aastrom has previously reported pre-clinical results of seven tumor-contaminated bone marrow samples that were grown using the AastromReplicell(TM) System process. Upon completion of the growth process, the presence of breast cancer cells in each sample was either substantially reduced or was no longer detectable. Further, in a separate study evaluating seven other samples containing tumor cells, a reduction in the level of tumor cells following expansion in the AastromReplicell(TM) System was also seen. This study also showed that in the few samples where tumor cells could still be identified, at reduced levels, in the post-expansion cell population, the tumor cells had lost their ability to grow (e.g. no longer clonogenic).
``These novel results show that AastromReplicell(TM) System stem cell production process can reduce or eliminate contaminating tumor cells which may contribute to the long term recovery results achieved by the patients in this study,' commented Dr. Stiff.
The AastromReplicell(TM) System consists of an instrumentation platform designed to operate a family of patient-specific cell therapy kits to produce cells for a broad range of cell therapy applications. Aastrom has developed two such therapy kits, the SC-I Therapy Kit for the production of bone marrow-derived stem cells and the CB-I Therapy Kit for the production of cord blood cells. Aastrom has initiated a Phase III-pivotal clinical trial evaluating the SC-I Therapy Kit in breast cancer patients and plans to initiate a Phase III-pivotal trial of the CB-I Therapy Kit. In addition to currently used stem cell therapies, many emerging cell therapies are being developed at academic institutions and other companies. The AastromReplicell(TM) System is designed to standardize these laboratory procedures. Once established for use in stem cell therapy, Aastrom plans to leverage the cell manufacturing capabilities of the AastromReplicell(TM) System across multiple cell therapy opportunities by providing a commercialization outlet for these therapies as new therapy kits for the astromReplicell(TM) System product line.
Aastrom Biosciences, Inc. is pioneering the development of proprietary clinical systems including the AastromReplicell(TM) System. 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 these cells. The AastromReplicell(TM) System is under development and is not available for sale at this time in the US except for research and investigational purposes.
This document contains forward-looking statements, including without limitation, statements concerning clinical trial results, product development, commercial introduction, 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 ``anticipates,' ``believes,' ``expects,' ``plans,' 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 uncertainties inherent in clinical trial and development activities, unforeseen potential problems in developing new therapy kits, regulatory approval requirements, availability of resources and the degree to which the Company's products achieve market acceptance. 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 |
