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Wednesday April 19, 8:00 am Eastern Time
Company Press Release
SOURCE: Aastrom Biosciences, Inc.
Study Gives New Hope to Adult Patients with Chronic Myelogenous Leukemia
- Results From Hackensack/Aastrom Studies Published in Bone Marrow Transplantation -
HACKENSACK, N.J. and ANN ARBOR, Mich., April 19 /PRNewswire/ -- Hackensack University Medical Center and Aastrom Biosciences, Inc. (Nasdaq: ASTM - news) today announced the publication of results from two adult patient case studies from a feasibility study evaluating the safety and efficacy of stem cell transplantation using cord blood that was produced ex vivo through the AastromReplicell(TM) System, in the treatment of Chronic Myelogenous Leukemia. The case studies, which were published in the April, 2000 issue of Bone Marrow Transplantation, showed that the AastromReplicell(TM) System could produce a quantity of umbilical cord blood (stem cells) large enough for therapeutic value in adult patients and facilitate blood and immune system recovery following aggressive chemotherapy.
``We are extremely encouraged by these results. Traditionally, use of cord blood stem cell transplants have been limited in adult patients given that the amount of stem cells available from a typical cord blood collection is simply too small to allow a patient to receive a potentially life-saving transplant,' said Andrew Pecora, MD, FACP, Chief of the Adult Blood and Marrow Stem Cell Transplant Service and Director of Medical Oncology/Hematology at Hackensack University Medical Center (HUMC). ``In these two case studies, the AastromReplicell(TM) System has enabled us to take a procedure, known to be effective in pediatric patients, and apply it to adult patients that had failed all other treatment options.'
Chronic Myelogenous Leukemia (CML)
CML is a type of cancer in which too many white blood cells are produced in the bone marrow. In patients with CML, bone marrow cells, that are supposed to develop into white blood cells (granulocytes), do not mature and become too numerous. CML usually affects middle-aged people and progresses though different stages, which are determined by how many immature white blood cells are found in the blood and bone marrow. The American Cancer Society estimates there will be 30,000 new cases of leukemias in 2000 and approximately 20,000 people will die from these diseases this year.
Treatment of CML typically involves administering very toxic drugs to the patient that are intended to kill the diseased white blood cells. Unfortunately, this treatment also kills other healthy blood and immune system cells and the patient's bone marrow. Donor bone marrow transplants (stem cell transplants), are often given to the patients following this therapy to produce healthy bone marrow and, as a result, a new blood system. Unfortunately, this procedure cannot be performed without a properly matched donor and such a donor is often difficult to find. Further, when unrelated donor stem cells are used, patients have a 60-90% chance of developing a tissue compatibility complication called graft-versus-host disease (GVHD) that often leads to severe complications including death. As a result, researchers continue to look for alternative sources of cells for transplantation and have found that cord blood can be an acceptable alternative to bone marrow. Cord blood is the blood in the umbilical cord and placenta after the birth of a child. Studies have indicated that a higher degree of tissue-mismatching can be tolerated with cord blood than with bone marrow and still provide an acceptable transplant. Additionally, with over 4 million births per year in the United States and a cord blood banking infrastructure being established, there is a growing source of cord blood for transplantation.
``While cord blood offers an alternative source of stem cells for transplantation, the small amount of cells available from a typical collection generally restricts its application to pediatric patients and small adults,' said Dr. Pecora. ``In order to apply this potentially life-saving procedure to adult patients, a larger quantity of cord blood cells is needed. In clinical experiments, The AastromReplicell(TM) System has been shown to increase the number of cord blood cells, therefore, we hypothesized that it would produce enough cells for a successful transplant in older, larger adult patients.'
Patient Case Studies
Two adult patients (a 48-year old male and 56-year old female) with high risk CML were each chosen to receive transplants using umbilical cord blood cells produced using the AastromReplicell(TM) System. Both patients had received prior therapy to treat their cancer, but after an initial response to treatment, one patient relapsed and the other showed signs of disease progression. Both patients needed to be given very high-dose chemotherapy to be followed by a stem cell transplant, however, no bone marrow donors could be found. Previously banked cord blood samples were identified for both patients, however were too small to be used. These patients were then selected to participate in the clinical trial where a portion of the cord blood samples were expanded using the AastromReplicell(TM) System (with the CB-I Therapy Kit) and subsequently infused into the patients.
Upon post-transplant evaluation (43 days for one patient and 74 days for the other) both patients tested negative for CML. Patients were evaluated again at 19 and 8 months respectively and remained in clinical remission. Neither patient experienced any adverse event commonly associated with transplants such as upper-grade GVHD.
``Both of these patients were at a very high risk as they had exhausted all available treatment options and no suitable bone marrow donor could be found,' said Dr. Pecora. ``These results suggest that we may have found a new treatment approach that will enable more patients to receive treatment for this very serious and often fatal disease.'
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 therapeutic applications. Each therapy kit is a single-use consumable product that is tailored to the specific cell type desired for therapeutic use. For this cord blood study, the CB-I Therapy Kit, designed for this purpose, was used. Aastrom has also developed the SC-I Therapy Kit for the production of bone marrow-derived stem 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. Additionally, Aastrom has recently initiated a product development program of a new OC-I Therapy Kit designed to produce therapeutic quantities of bone-forming cells to aid in the treatment of bone degenerative diseases such as osteoporosis. The AastromReplicell(TM) System is designed to standardize cell therapy-related laboratory procedures so that they can be incorporated into general medical practice. 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.
Hackensack University Medical Center, a teaching hospital affiliated with the University of Medicine and Dentistry of New Jersey-New Jersey Medical School and a member of the University Health System of New Jersey, is the largest provider of inpatient and outpatient services in the state of New Jersey. The medical center is the recipient of the Consumer Choice Award in Bergen and Passaic counties for four consecutive years. Based on a survey of 400,000 people to determine the best hospitals in the country, the medical center was named as the hospital of choice for quality of staff, community programs, personalized care, and overall reputation. Servicing more than 20,000 patients a year, the Northern New Jersey Cancer Treatment and Prevention Center provides the most advanced cancer treatments, such as cutting-edge chemotherapy treatments; radiation therapy; bone marrow and stem cell transplantation; and the latest surgical procedures. The center also offers a wide range of psychosocial support programs and services to help patients cope with their cancer experience.
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 and potential advantages of the AastromReplicellTM 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 requirement and availability of resources. 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.
SOURCE: Aastrom Biosciences, Inc. |
