Hey man,,,,this is better than i-nut stuff,,,this is serious hope
for cancer patients. If CNBC can't see that, t'would be very sad indeed.....
Aastrom Biosciences Initiates Pivotal Trial of The
AastromReplicell(TM) System in Breast Cancer Patients
ANN ARBOR, Mich., Dec. 2 /PRNewswire/ --Following positive
results from initial studies announced in October 1998, Aastrom
Biosciences, Inc. (Nasdaq: ASTM) announced today the initiation of a
pivotal clinical trial to evaluate the use of the AastromReplicell(TM)
Cell Production System (System) to provide an alternative method of
cell collection for cancer patients requiring an autologous stem cell
transplant.
Results from an earlier multi-center trial, completed under an
Investigational Device Exemption (IDE) from the U.S Food and Drug
Administration (FDA), demonstrated that patients achieved rapid
blood cell and immune system recoveries when treated with a
combination of bone marrow cells produced in the
AastromReplicell(TM) System and a low dose of peripheral blood
stem cells (PBSC) collected in a single blood apheresis procedure. In
spite of the low doses of PBSC used, which for some of the patients
treated was as low as one-tenth of an optimal targeted dose of PBSC,
the median recovery times for platelets and neutrophils for these
patients were comparable to the average rates reported for similar
patients receiving standard doses of PBSC collected through multiple
blood apheresis cycles.
"The results from our previous clinical trial demonstrated that blood
and immune system recoveries for patients treated with a combination
of cells produced in the AastromReplicell(TM) System, plus a low
dose of PBSC, appear to provide targeted recovery rates similar to
patients treated with traditional large-dose PBSC methods involving
multiple blood apheresis collection procedures," said R. Douglas
Armstrong, Ph.D., President and Chief Executive Officer of Aastrom.
"The pivotal trial represents an extension of the earlier trial and will
now include the addition of a randomized control patient group
receiving standard of care PBSC. We believe the subsequent trial results
will further demonstrate the clinical utility of the
AastromReplicell(TM) System to produce therapeutic quantities of
cells for the treatment of cancer patients."
Dr. Armstrong added, "We recently achieved our first product objective
with receipt of the CE Mark and approval to market the
AastromReplicell(TM) System instrument platform in Europe. We
expect similar approvals by year-end for our two lead therapy kits used
in the production of bone marrow and umbilical cord blood cells used in
stem cell therapy. We intend to use this growing body of positive
clinical data to support marketing activities in Europe and to later
support a Pre-Market Approval Application with the FDA."
The AastromReplicell(TM) System is designed to be a first of its kind
product, providing a cost-effective, efficient method to produce cells
useful in a broad range of therapies. The AastromReplicell(TM)
System clinical trial intends to demonstrate a solution to some of the
key problems in the current field of cell therapy by offering patients a
potentially less invasive and more reliable cell collection procedure.
Invasiveness, cost and procedure uncertainty represent challenges and
concerns in current stem cell therapy practice. The results of the clinical
trials completed to date indicate that the AastromReplicell(TM)
System has the potential to address these challenges and may offer
many patients a better overall standard of care. The potential of this
procedure is particularly promising for the large percentage of patients
for whom the desired therapeutic dose of PBSC can either not be
achieved, or requires multiple cycles of blood apheresis to do so. The
pivotal trial will elucidate if these patients have acceptable bone
marrow for use in the AastromReplicell(TM) System, which may
provide an opportunity for an optimal transplant recovery with only a
single apheresis procedure.
Stem cell transplants are commonly used to treat patients with cancer
or other diseases who have undergone extensive chemotherapy or
radiation treatments. These therapies damage or destroy the patient's
bone marrow and blood and immune system cells. Consequently,
patients receive a stem cell transplant to restore these vital cells and
tissues. Standard practice in stem cell therapy involves collecting a large
number of stem cells through multiple PBSC apheresis procedures, each
of which typically lasts from three to five hours. A dose of 5 x 10(6)
CD34+ cells/kg is generally viewed as an optimal target dose of cells for
transplantation use. More often, patients receive 2.0 to 2.5 x 10(6)
CD34+ cells/kg, and in a significant number of patients, collection of
1.0 x 106 CD34+ cells/kg cannot be obtained even after multiple blood
apheresis procedures. Such lower transplant cell doses generally lead to
delayed patient recoveries following the transplant. Study Design and
Rationale
The trial will be conducted at three to four clinical sites and will enroll a
minimum of 80 patients with Stage II-IV breast cancer who have
undergone ablative chemotherapy and require a stem cell transplant.
The trial format is an extension of the feasibility trial with the addition
of a randomized control group of patients. Patients will be randomized
to either receive a targeted dose of PBSC, generally collected through
multiple blood apheresis procedures, or stem cells produced with the
AastromReplicell(TM) System in combination with a low dose of
PBSC, collected from a single apheresis procedure. Reduction in cell
collection and apheresis procedures, and recovery of the patient's blood
and immune system function within an equivalent recovery period to
that provided with standard methods are, respectively, the primary
efficacy and safety endpoints for the study. As secondary endpoints,
the study will evaluate the number of days that the patient is at
significant risk of infection following the transplant (febrile
neutropenia), and the level of tumor cell contamination in
AastromReplicell(TM) System-produced cells in comparison to cells
collected through the standard PBSC apheresis method. Clinical Impact
of the AastromReplicell(TM) System
The AastromReplicell(TM) System is an automated clinical system
designed to be used on-site by hospital personnel to produce
therapeutic cells from small starting quantities. By combining
AastromReplicell(TM) System-produced cells with a dose of PBSC
obtained from a single blood apheresis procedure, this procedure may
provide an efficient and consistent method for stem cell therapy, with
more predictable treatment schedules. In addition, because the
procedure can be performed with a very low dose of PBSC, it may
enable the treatment of certain patients who might not otherwise be
eligible for stem cell transplants due to the inability to obtain a
sufficient quantity of cells even after multiple apheresis procedures.
The AastromReplicell(TM) System procedure may also reduce the
incidence of tumor cell contamination in the transplant by reducing the
overall large-volume cell collection apheresis requirement.
Aastrom Biosciences, Inc. is pioneering the development of proprietary
clinical systems including the AastromReplicell(TM) System, a first of
its kind product, to enable physicians and patients greater accessibility
to cells used for therapy. The AastromReplicell(TM) System product
line consists of an instrumentation platform that can operate a growing
number of patient specific therapy kits tailored to each cell therapy
application. 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(TM) System is an experimental device under
development, and is not available for sale at this time in the U.S.
This document contains forward-looking statements, including without
limitation, statements concerning clinical trial results, product
development objectives, 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,
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.
/CONTACT: Todd E. Simpson, VP Finance & Administration, CFO of
Aastrom Biosciences, Inc., 734-930-5777 or Investor & Media:
Francesca T. DeVellis of Feinstein Kean Partners Inc., 617-577-8110/
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