[MOL] Study Gives New Hope to Adult Patients with Chronic Myelogenous [01892] Medicine On Line


[Date Prev][Date Next][Thread Prev][Thread Next][Date Index][Thread Index]

[MOL] Study Gives New Hope to Adult Patients with Chronic Myelogenous



Good Morning My FRiends,

This is a bit lengthy but may be of some great value to those that are
affected by this disease.\\\\

 Study Gives New Hope to Adult Patients with Chronic Myelogenous
         Leukemia

Study Gives New Hope to Adult Patients with Chronic Myelogenous Leukemia

April 19, 2000

- 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)
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.

God Bless You,
marty auslander
------------------------------------------------------------------------
This is an automatically-generated notice.  If you'd like to be removed
from the mailing list, please visit the Medicine-On-Line Discussion Forum
at <http://www.meds.com/con_faq.html>, or send an email message to:
majordomo@lists.meds.com
with the subject line blank and the body of the message containing the line:
unsubscribe mol-cancer your-email-address
where the phrase your-email-address is replaced with your actual email
address.
------------------------------------------------------------------------