RANCHO CORDOVA, Calif., Dec. 19 /PRNewswire-FirstCall/ -- ThermoGenesis
Corp. (Nasdaq: KOOL) Chairman & CEO, Philip Coelho, commented on the passage
of the Stem Cell Therapeutic and Research Act of 2005. "This Bill, sponsored
in the Senate (S-1317) by Senator Orrin Hatch and in the House of
Representatives (HR-2520), by Representatives Chris Smith and Artur Davis,
amends the Public Health Service Act to establish a National Cord Blood Stem
Cell Bank Network to prepare, store and distribute 150,000 units of human
umbilical cord blood stem cells for the treatment of patients and to support
peer-reviewed research using such cells. This authorizing legislation
provides $79 million in funds to follow the previous $19 million already
appropriated as direct grants to qualified cord blood banks to manufacture the
national inventory. The Office of Management and Budget has projected the full
cost of the authorized inventory to be $225 million over the next several
Neonatal cord blood stem cells are used in the treatment of more than
60 malignant, genetic and acquired blood diseases, such as leukemia, lymphoma,
sickle cell anemia, thalassemia, and immunodeficiency (boy in the bubble
disease). Cord blood as a source of stem cells is more rapidly available than
bone marrow, a critical factor should a radiation incident occur, and provides
survival rates for patients with these usually fatal diseases that can be as
good, or better, than those following adult donor bone marrow stem cell
transplants. Cord blood stem cell transplants are already curing hundreds of
U.S. patients from lethal diseases each year and this 150,000-unit inventory
will provide life saving stem cell transplants for the more than ten thousand
patients each year who need them and cannot currently get them from the
"walking donor" bone marrow registries (as disclosed in the GAO Report,
October 2002). Recent peer reviewed articles have underscored that stem cells
residing in cord blood can differentiate into other tissues of the body,
thereby becoming candidate cells to explore treatments such as diabetes,
spinal cord damage and Parkinson's.
According to Mr. Coelho, "ThermoGenesis has actively supported this
legislation since its initiation in 2003. Beyond the important funding, we
have long anticipated that federal oversight will mandate critical processing
standards that will assure that the National Inventory includes only the
highest quality cord blood stem cell units. We have worked toward this goal
and assisted the evolution of this new stem cell therapy by developing
"enabling technologies" such as the BioArchive(R) and the AutoXpress(TM)
Systems. The BioArchive System is utilized by the major cord blood stem cell
banks in 26 countries to automate the precision cryopreservation and archiving
of units of cord blood stem cells. The AutoXpress System, scheduled for
market launch in January 2006, automates the harvesting of stem cells from
cord blood in a closed sterile process. Both the BioArchive and the AutoXpress
Systems are marketed and serviced globally by GE Healthcare."
History of Cord Blood Transplants
Following the first sibling-donor cord blood transplant in 1988, the
National Institute of Health (NIH) awarded Dr. Pablo Rubinstein a grant to
develop the worlds first cord blood program at the New York Blood Center
(NYBC), in order to establish the inventory of stem cell units necessary to
provide unrelated, matched grafts for patients (1992). In 1993, Dr. Joanne
Kurtzberg, Duke University Medical Center, performed the first two successful
cord blood transplants, in the unrelated setting, one of which cured a patient
with acute lymphoblastic leukemia (ALL). Currently, more than 7,000 unrelated
transplants have been provided to patients worldwide.
By 1996, with more than 300 unrelated transplants accomplished, the FDA
accepted the NYBC's request for an Investigational New Drug (IND) Exemption
which allowed the expansion of the clinical use of cord blood under conditions
that documented the critical processing protocols and the clinical outcome
data which would allow the FDA to understand how best to regulate this
promising cell therapy. Today, the FDA is preparing to license this cell
therapy product and, therefore, assure that this national inventory will be in
compliance with the highest quality standards.
About ThermoGenesis Corp.
ThermoGenesis Corp. is a leader in enabling technologies for cell
therapeutics. The Company's technology platforms lead the world in their
ability to produce biological products from single units of blood.
-- The BioArchive System, an automated robotic cryogenic device, is used
by major cord blood stem cell banks in 26 countries as a key enabling
technology for cryopreserving and archiving cord blood stem cell units
-- The AutoXpress System, is a semi-automated robotic device and companion
sterile closed blood processing disposable, to harvest stem cells from
-- The CryoSeal(R) FS System, a semi-automated device and companion
sterile blood processing disposable, is used to prepare hemostatic and
adhesive surgical sealants from the patient's blood in about an hour.
Enrollment in a 150 patient U.S. pivotal clinical trial has been
completed and a PMA is being prepared.
-- The Thrombin Processing Device(TM) (TPD(TM)) is a sterile blood
processing disposable that prepares activated thrombin from a small
aliquot of patient blood, or blood plasma in 25 minutes. The TPD
market launch is underway in Europe.
The statements contained in this release which are not historical facts
are forward-looking statements that are subject to risks and uncertainties
that could cause actual results to differ materially from those expressed in
the forward-looking statements, including, but not limited to, certain delays
beyond the company's control with respect to market acceptance of new
technologies and products, delays in testing and evaluation of products, and
other risks detailed from time to time in the Company's filings with the
Securities and Exchange Commission.
For More Information, Contact:
Philip H. Coelho: (916) 858-5100
Or Fern Lazar (212) 867-1762
or visit the web site at www.thermogenesis.com
SOURCE ThermoGenesis Corp.