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<<<Aastrom Biosciences Presents Clinical Results at The American
Society of Hematology Meeting
MIAMI, Dec. 7 /PRNewswire/ -- Multi-center clinical trial results
presented at the annual scientific meeting of the American Society of
Hematology (ASH) have provided further evidence of the safety and
clinical utility of the AastromReplicell(TM) Cell Production System
(System) for stem cell transplantation, according to Aastrom
Biosciences, Inc. (Nasdaq: ASTM). Results from four clinical studies
conducted at multiple sites will be used to support European marketing
efforts to begin later this year, and to establish the use of the
AastromReplicell(TM) System for production of bone marrow and cord
blood cells for transplantation.
The data presented at ASH were compiled from clinical studies
evaluating the AastromReplicell(TM) System and the Company's two
lead therapy kits for the production of bone marrow cells (SC-I Therapy
Kit) or umbilical cord blood cells (CB-I Therapy Kit) for use in stem cell
therapy in patients with cancer and other blood diseases. The
AastromReplicell(TM) System is an automated clinical system designed
to enable hospitals to produce patient-specific cells for use in the
treatment of a broad range of diseases including cancer, infectious
diseases, auto-immune diseases as well as cells used in the restoration of
solid tissues. The AastromRepliCell(TM) System product line consists
of an instrumentation platform that operates single use therapy kits.
"These new data substantially advance our development program for the
AastromReplicell(TM) System in enabling new approaches in stem cell
therapy for cancer patients," said R. Douglas Armstrong, Ph.D.,
President and CEO of Aastrom. "Most importantly, the studies begin to
demonstrate the potential clinical benefits of the AastromReplicell(TM)
System as we approach European market introduction of the product
line for stem cell therapy. These potential benefits include improving
patient care and enabling transplants to be performed when they
otherwise might not have been feasible." Advancements in Pediatric and
Adult Cord Blood Transplantation
Cord blood is emerging as a promising new source of stem cells for use
in therapy. Cord blood, which remains in the umbilical cord and placenta
after child birth, is a rich source of stem cells that can be used to restore
tissue destroyed by aggressive chemotherapy or radiation therapy used
in the treatment of cancer and other diseases. However, there is a limited
quantity of cells available from a standard cord blood collection, which
generally restricts cord blood transplants to small patients and results in
recovery times that can be quite long. Results from two studies were
presented at ASH which evaluated the use of the AastromReplicell(TM)
System to expand cord blood cells and to increase the quantity of cells
available for transplant. These studies involved the transplantation of
unmanipulated cord blood cells, followed 12 days later by a second
transplant of cord blood cells expanded in the AastromReplicell(TM)
System.
The first study, led by Joanne Kurtzberg, M.D., Director of the
Pediatric Bone Marrow Transplant Program at Duke University
Medical Center, was conducted to evaluate the clinical utility of the
AastromReplicell(TM) System to increase the transplantation dose of
cord blood cells for pediatric patients. The trial enrolled 25 patients and
showed that use of the AastromReplicell(TM) System to increase the
number of cells available for transplant could enable similar engraftment
times to those seen when a larger dose of unexpanded cells is available
and used. Although results are preliminary, the study also suggests an
apparent improvement in the 100-day post transplant survival rates for
the study patients when compared to historical control patients.
"The follow-up performed to date suggests that there may be a survival
advantage for patients receiving a cell dose expanded ex vivo with the
AastromReplicell(TM) System, as compared to our historical controls,"
said Dr. Kurtzberg. "Results of the trial support a continued study of
the AastromReplicell(TM) System, as a means to increase the number
of stem cells available for transplantation in our pediatric patients. We
hope that this new technology will help these patients by offering a
larger transplantation cell dose."
Low transplantation cell dose is particularly problematic for larger and
older patients where cord blood transplantation is generally not
attempted. Initial observations from a study conducted at Hackensack
University and Loyola University Medical Center demonstrated that ex
vivo expansion of cord blood cells using the AastromReplicell(TM)
System, enabled adult patients to undergo a transplant when a sufficient
cell dose of cord blood stem cells was otherwise unavailable. This study
involved nine patients with advanced hematologic cancers who had
undergone ablative therapy. The median weight of the patients
transplanted was 74 kilograms (range 47 to 117 kilograms), and the data
presented showed that four of the patients who received this treatment
are alive at 56 to 292 days post-transplant.
These results may yield a new therapeutic approach for adult patients
with otherwise incurable hematologic disorders. By being able to expand
cord blood cells to larger quantities using the AastromReplicell(TM)
System, patients may have a new treatment option when an acceptable
bone marrow donor cannot be found. Procedure Improvements in Stem
Cell Transplantation
Results from another clinical study evaluated ex vivo expanded bone
marrow cells in combination with sub-therapeutic doses of peripheral
blood stem cells (PBSC) in cancer patients who had undergone extensive
chemotherapy. The study, conducted by clinicians at Hackensack
University, Loyola University Medical Center and the South Texas
Cancer Institute, involved 31 patients and evaluated the effect on
hematopoietic recovery rates by combining ex vivo expanded bone
marrow cells with low doses of PBSC collected in a single blood
apheresis collection.
The study demonstrated that the combination of ex vivo expanded bone
marrow cells with PBSC collected in a single blood apheresis procedure
resulted in hematopoietic recovery rates similar to that reported for
patients receiving significantly higher doses of PBSC, typically collected
in multiple apheresis procedures. In these studies, median recovery
times to absolute neutrophil count greater than 500 and platelets greater
than 20,000 for patients receiving 0.5 to 0.7 x 10(6) CD34+ cells/kg
collected from a single blood apheresis procedure, plus ex vivo expanded
cells were 10 and 11 days, respectively.
"The ability of the, AastromReplicell(TM) System procedure to reduce
the required PBSC dose and corresponding number of blood apheresis
procedures, concurrent with offering the patient the opportunity for an
optimal recovery, may address several of the unmet needs in stem cell
transplantation," said Dr. Armstrong. "The addition of ex vivo expanded
bone marrow to the sub-therapeutic doses of PBSC evaluated in this
study, resulted in transplant recoveries that were similar to patients who
receive a dose of PBSC alone that is as much as ten times greater.
Additionally, decreasing the required dose of PBSC and the number of
apheresis procedures using the AastromReplicell(TM) System
procedure may potentially decrease the risk of tumor cell contamination
and enable transplants for patients where otherwise only
sub-therapeutic PBSC collections could be completed." Data to Support
European Market Introduction
In October of this year Aastrom announced that it obtained its initial
approval to affix the CE Mark to the AastromReplicell(TM) System
instrumentation platform. This instrumentation platform is designed to
operate therapy-specific kits including the Company's lead therapy
evaluated in the trials reported at ASH. Approval to affix the CE Mark
to the remaining components of these therapy kits is pending. Upon
receipt of these remaining approvals and completion of production
manufacturing of the AastromReplicell(TM) System, the Company
plans to initiate marketing activities in Europe.
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 in the U.S. at this time.
This document contains forward-looking statements, including without
limitation, statements concerning product development and
commercialization objectives 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 than may result in differences are the results obtained from
clinical trial and development activities, regulatory approval
requirements, risks associated with market acceptance of the Company's
products, 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.
/CONTACT: Todd Simpson, Sr. VP Finance & Administration, CFO of
Aastrom Biosciences, Inc. 734-930-5777 or Francesca T. DeVellis of
Feinstein Kean Partners Inc., 617-577-8110/ >>> |
