MORE GOOD NEWS:
Aastrom To Initiate Clinical Trials Of Umbilical Cord Blood Transplants In Adult And Pediatric Cancer Patients
PR Newswire, Wednesday, September 24, 1997 at 08:11
Cells Produced Using the Aastrom(TM) CPS May Result in More Effective
Therapeutic Doses of Tumor-Free Cells than Currently Available
ANN ARBOR, Mich., Sept. 24 /PRNewswire/ -- Aastrom Biosciences, Inc.
(NASDAQ:ASTM) today announced that the U.S. Food and Drug Administration
(FDA) has granted an Investigational Device Exemption (IDE) for the Company to
initiate clinical feasibility trials to evaluate the use of cells, produced
ex vivo from umbilical cord blood (UCB), to treat patients who require a stem
cell transplant to restore their blood and immune systems following therapy.
The studies will utilize the Aastrom(TM) Cell Production System (CPS) to
produce therapeutic cells from a small starting amount of UCB and will involve
the treatment of up to 30 adults and children with cancer, immunodeficient or
genetic diseases, who do not have other appropriately matched bone marrow
donors. The adult cancer patient study is being directed by Patrick J. Stiff,
M.D., Director of the Bone Marrow Transplant program at Loyola University
Medical Center in Chicago, Illinois. The pediatric patient study is being
directed by Joanne Kurtzberg, M.D., Director of the Pediatric Bone Marrow
Transplant Program at Duke University Medical Center, Durham, North Carolina.
"We are very encouraged by our preclinical results demonstrating the
capability of the Aastrom(TM) CPS to produce the desired types and quantities
of stem and progenitor cells from a small amount of starting umbilical cord
blood necessary for transplantation. Because of the limited quantity of cells
available in an UCB sample, such transplants have been generally limited to
children and characterized by prolonged recovery times. The use of the
Aastrom(TM) CPS for the ex vivo production of clinically useful quantities of
cells from UCB may potentially address these cell quantity limitations," said
R. Douglas Armstrong, Ph.D., President and CEO of Aastrom. "The initiation of
these FDA-reviewed studies represents an important milestone in Aastrom's
clinical and commercial development of the Aastrom(TM) CPS and our continued
strategy to broaden the clinical utility of the product."
UCB transplantation is being increasingly used to treat patients who have
diseases of the bone marrow, and blood and immune systems, such as various
forms of leukemia. Umbilical cord blood is the blood that remains in the
umbilical cord and placenta after childbirth and contains stem cells that can
form healthy normal tissue following patient treatment with chemotherapy drugs
or radiation to eradicate the diseased cells. The widespread practice of UCB
transplants has been hampered by the limited quantity of donor cells, and the
previous difficulty in expanding the number of cells to therapeutic
quantities. Another limitation of UCB is a reduced number of progenitor cells
that are available for transplant. Progenitor cells provide for early
recovery of white blood cells and platelets needed to prevent infection and
uncontrolled bleeding. These studies will evaluate the ability of the
Aastrom(TM) CPS to produce these important cells from UCB.
"We are particularly excited by this trial because the cell expansions
made possible by the Aastrom(TM) CPS will open up the possibility of a
curative transplant procedure to a large number of adults who either do not
have a matched related donor or cannot be matched to a donor through one of
the national or international bone marrow registries," said Dr. Stiff.
"Currently, UCB transplants are generally limited to children because only a
small number of cells are available from each cord blood sample. The success
for this type of transplant is largely based on the number of cells
transplanted per kilogram of body size. By expanding the number of stem cells
using the Aastrom(TM) CPS, we hope to broaden the application of this exciting
new form of transplantation."
Commenting on the pediatric study, Dr. Kurtzberg said, "This is an
important development in the use of UCB as a source of cells for stem cell
transplantation in children. We are encouraged by the capabilities of the
Aastrom(TM) CPS as a clinical system to increase the number of cells
available to potentially address the prolonged engraftment times typical of
unexpanded UCB cell transplants in our pediatric patients. We hope that this
will decrease the incidence and severity of chemotherapy and radiation therapy
toxicity in these patients."
The collection of UCB is non-invasive and without pain or risk to the
mother or infant. Rich in the stem cells that form bone marrow and critical
cells, UCB cells are believed to be tumor-free and appear to help overcome the
problem of tissue incompatibility between donors and patients. Tissue
rejection currently limits the use of bone marrow transplantation when an
appropriately "matched" donor is not available. The ability to find an
acceptable donor tissue match for transplants provides greater opportunities
for UCB than for bone marrow, and UCB cells are being increasingly used as an
alternative to traditional stem cell transplants for the treatment of a number
of life-threatening diseases.
The collection of UCB cells is relatively easy, and the collected cells
can be economically frozen until needed. Several UCB banking (or storage)
centers have recently been established in the United States. These include,
the New York Blood Center and three new centers recently funded by the
National Institutes of Health: Duke University, Children's Hospital of Orange
County, California and the University of California, Los Angeles.
Aastrom and Loyola University Medical Center recently announced, at the
annual meeting of the American Society of Clinical Oncology (ASCO), results of
a study directed by Dr. Stiff of the first successful clinical trial
evaluating the use of the Aastrom(TM) CPS to produce bone marrow stem cells to
restore the bone marrow tissue of breast cancer patients following high-dose
chemotherapy. Dr. Stiff explained that, "For patients who have solid tumor
cancers, such as breast cancer or lymphoma, their own stem cells can be
collected, stored and expanded in the Aastrom(TM) CPS, and then used for
transplant. Patients who have malignancies of the blood or bone marrow, such
as leukemia, require a donor-derived source of stem cells. This source of
cells is available from donor bone marrow, and potentially now, umbilical cord
blood."
Aastrom Biosciences, Inc. is pioneering the development and
commercialization of proprietary medical product systems, including the
Aastrom(TM) CPS and the Aastrom(TM) Gene Loader. These technology platforms
are expected to enable the practice of stem cell therapy and other cell and ex
vivo gene therapies at clinical sites worldwide. Aastrom has received patents
for the production of human stem cells ex vivo, as well as for the genetic
modification of stem cells. In 1993, Aastrom entered into a marketing
alliance with COBE BCT, a world leader in blood cell processing products.
Subject to the terms of the agreement, COBE BCT will market, distribute and
provide customer service for the Aastrom(TM) CPS worldwide for stem cell
therapy, including treatments that may be developed using the Aastrom(TM) CPS
to produce stem cells from UCB.
This document contains forward-looking statements, including without
limitation statements concerning clinical trial timing and results, and
potential advantages of the Aastrom(TM) CPS, which involve certain risks and
uncertainties. Actual results may differ significantly from the expectations
contained in the forward-looking statements. Among the factors that may
result in differences are the results obtained from clinical trials,
competitive developments, collaborations with other companies and the
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.
-0- 9/24/97
/CONTACT: Todd Simpson, Chief Financial Officer of Aastrom Biosciences,
Inc., 313-930-5777 or Media: Peter Steinerman of Feinstein Kean Partners Inc.,
516-374-3031 or Investor Contact: Lucy L. Morrison or Francesca T. DeVellis of
Feinstein Kean Partners Inc., 617-577-8110 or Mike Maggio, Office of Media
Relations of Loyola University, 708-216-3200 or Karen Hines, News Office of
Duke University, 919-684-4148/
Companies or Securities discussed in this article:
SymbolNameNASDAQ:ASTM |
