AASTROM Biosciences Announces FDA Approval to Initiate a Stem Cell Transplantation Trial of the AASTROM Cell Production System.

ANN ARBOR, Mich.--(HealthWire)--Jan. 10, 1995--AASTROM Biosciences, Inc. has received permission from the United States Food and Drug Administration (FDA) to initiate a clinical trial of the AASTROM(TM) Cell Production System ("CPS") at the M.D. Anderson Cancer Center in Houston, Texas. The trial is directed towards establishing the safety of the AASTROM(TM) CPS and securing FDA approval for its sale as a medical device.

The first phase of the trial will involve treatment of up to ten breast cancer patients, to be conducted under an Investigational Device Exemption (IDE). The trial will be directed by Drs. Albert Diesseroth, M.D. and Richard Champlin, M.D., heads of the Department of Hematology-Oncology and the Bone Marrow Transplant Program, respectively. Cells produced by the AASTROM(TM) CPS will be used to enhance the recovery of the patients' blood and immune systems after high dose chemotherapy involving bone marrow transplantation.

AASTROM is the first and only company to successfully produce human stem cells outside the body (Blood, 82(2), 1993, pp. 378-384). AASTROM believes that the combination of growth factor-enhanced stem and progenitor cells produced by the AASTROM(TM) CPS, which it terms "Ideal Transplant Cells," will obviate the current use of bone marrow and other sources of stem cells to rescue patients from the toxic effects of chemotherapy and radiation therapy for cancer. Cells similar to Ideal Transplant Cells have been used to successfully treat thousands of cancer patients over the past decade, albeit using relatively cumbersome techniques.

Stem cells are currently obtained by processing a large volume of patient or donor bone marrow, surgically aspirated under general anesthesia in the operating room, or by processing several-to-many body volumes of blood over many hours, followed by extensive laboratory processing and liquid nitrogen frozen storage. These procedures are costly, invasive, and difficult to implement and manage. Current charges in the United States for the procurement and processing of stem cells range from approximately $7,000 to $20,000, not including the added potential costs of experimental stem cell selection technology, which confers uncertain incremental benefit.

In contrast, the AASTROM(TM) CPS can utilize a small, 15 mL sample of bone marrow, such as may be obtained in a brief doctor's office procedure, or other stem cell sample to directly produce a projected therapeutic dose of Ideal Transplant Cells. AASTROM believes these Cells can be used simply and cost-effectively to provide rapid, permanent recovery of blood and immune system function following myelosuppressive cancer treatments, such as chemotherapy and radiation therapy.

Aggressive cancer therapies have become standard of care for some types of leukemia and lymphoma in spite of their inherent toxicity, based on their ability to cure a larger number of patients of their cancer. Currently, large randomized clinical trials in breast cancer, ovarian cancer, and other chemotherapy dose-responsive cancers are also demonstrating promising improvements in patient disease-free survival from the application of similar chemotherapy regimens. Stem cells have dramatically reduced the toxicity of these procedures. As a result, many high-risk breast cancer and other patients are being referred to major cancer centers for intensive chemotherapy with stem cell transplantation. Many insurance companies are now routinely providing reimbursement for these procedures.

The AASTROM(TM) Cell Production System has the potential to make the delivery of aggressive cancer therapy more cost effective and practical for local hospitals and oncology practice groups as well as for major cancer centers. AASTROM is developing a fully automated version of the AASTROM(TM) CPS which may be supervised by a conventional Medical Technologist with minimal requirement of labor and laboratory space, and which can be readily configured for treatment of a small number of cancer patients per year or the very large numbers of patients treated at major health care institutions.

AASTROM's goal is to enable the on-site production of stem and gene-engineered cells, as well as other tissues, for a wide range of cellular and gene therapy procedures. Future applications of the AASTROM(TM) CPS will include multiple areas of Cell Therapy, including lymphocyte and other areas of blood therapy and stem cell gene therapy. AASTROM's Gene Loader(TM) technology for enhancing gene transfer into human cells and tissues will be integrated with the company's cell production technology to enable the successful, cost-effective delivery of a wide variety of important gene therapies in the clinic. AASTROM is pursuing collaborative relationships with gene therapy companies to effectively address these current obstacles to successful commercialization of gene therapies.

In 1993, AASTROM entered into a strategic marketing alliance with COBE BCT, Inc. a Gambro Group company (Sweden). COBE BCT, Inc. is a world leader in the development, manufacture and sale of innovative, high-quality blood separation products, including the Spectra(TM) apheresis system. COBE BCT, Inc. will distribute the AASTROM(TM) CPS through its worldwide marketing, sales and service organization, providing AASTROM with immediate, effective access to the stem cell transplantation market. AASTROM has retained rights to markets other than stem cell transplantation.

FDA approval to initiate clinical trials of the AASTROM(TM) CPS further establishes AASTROM Biosciences as a leading company in Cell Therapy. AASTROM Biosciences, Inc. is a privately held medical products company based in Ann Arbor, Michigan.

CONTACT: AASTROM Biosciences, Inc., Ann Arbor

R. Douglas Armstrong or Walter C. Ogier, 313/930-5555