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Aastrom Biosciences and Loyola University Announce First Successful Transplants of Ex Vivo Produced Stem Cells in Cancer Patients - Positive Clinical Results Published in March Issue of Blood -
Aastrom Biosciences and Loyola University Announce First Successful
Transplants of Ex Vivo Produced Stem Cells in Cancer Patients - Positive
Clinical Results Published in March Issue of Blood -
MAYWOOD, Ill. and ANN ARBOR, Mich., Mar 15, 2000 /PRNewswire via COMTEX/ --
Loyola University Medical Center and Aastrom Biosciences, Inc. (Nasdaq: ASTM)
announced today the publication of positive clinical results describing the
first ever successful transplants of ex vivo-produced (produced outside of the
body) human stem cells in breast cancer patients. The human stem cells used for
transplantation were produced using the AastromReplicell(TM) Cell Production
System and SC-I Therapy Kit. These results, which appear in March 15, 2000 issue
of the journal Blood, report clinical trial results and long-term follow-up of
ex vivo produced stem cells used for transplantation.
"Typical stem cell collection methods including surgical bone marrow harvest or
peripheral blood stem cell (PBSC) mobilization and blood apheresis, can be
invasive to the patient, expensive to perform and may result in the unintended
collection, and ultimately, re-transplantation, of tumor cells," said Patrick J.
Stiff, MD, Director of the Bone Marrow Transplantation Program at Loyola
University Medical Center. "The results from this study represent a significant
advancement in stem cell transplantation as they demonstrate that
transplantation of ex vivo produced stem cells can effectively restore a
patient's blood and immune system as well as offer a procedure that may reduce
or eliminate the re-infusion of contaminating tumor cells," Dr. Stiff concluded.
Cancer patients often undergo chemotherapy or radiation therapy in an attempt to
eradicate cancer cells. High dose therapies however, can damage or destroy the
patient's bone marrow and their blood and immune system function. Stem cell
transplantation is used following such treatments to facilitate the restoration
of healthy bone marrow and to reestablish normal blood and immune system
function. The AastromReplicell(TM) System, currently in Phase III-pivotal
clinical evaluation, is a first of its kind product to enable physicians to
produce cells for use in therapeutic procedures.
Clinical Trial Design
This Phase II clinical trial evaluated the safety and efficacy of stem cell
transplants using human stem cells produced ex vivo with the
AastromReplicell(TM) System. This study included 19 patients with Stage II-IV
(12 of whom had Stage II/IIIa) breast cancer who have undergone ablative
chemotherapy to treat their cancer. Patients received transplants of stem cells
produced from a small starting volume of autologous bone marrow in the
AastromReplicell(TM) System using the SC-I Therapy Kit. The study was intended
to evaluate whether stem cells produced ex vivo in the AastromReplicell(TM)
System could be used by themselves to restore blood and immune system function
following aggressive chemotherapy and evaluated the time to engraftment of the
patients' key infection fighting white blood cells (neutrophils) and
blood-clotting cells (platelets) to control bleeding.
Clinical Trial Results
Clinical results showed that recovery of the patients' neutrophils and platelets
exhibited recoveries that were similar to results seen with traditional bone
marrow transplants. The median times to absolute neutrophil count (ANC) and
platelet engraftment were 16 and 24 days, respectively. Results also showed no
late engraftment failures, even following subsequent chemotherapy or radiation
therapy. The Company also reported, at the Annual Meeting of the American
Society of Hematology in December 1999, that of the 12 patients in this study
that had stage II/IIIa breast cancer, 92 percent (11 patients) remained
progression-free at a median time since transplant of 27 months. This suggested
a better than expected progression-free survival for the patients as compared to
that seen with standard PBSC transplants at Loyola.
In addition to these clinical results, Aastrom has previously reported
pre-clinical results of seven tumor-contaminated bone marrow samples that were
grown using the AastromReplicell(TM) System process. Upon completion of the
growth process, the presence of breast cancer cells in each sample was either
substantially reduced or was no longer detectable. Further, in a separate study
evaluating seven other samples containing tumor cells, a reduction in the level
of tumor cells following expansion in the AastromReplicell(TM) System was also
seen. This study also showed that in the few samples where tumor cells could
still be identified, at reduced levels, in the post-expansion cell population,
the tumor cells had lost their ability to grow (e.g. no longer clonogenic).
"These novel results show that AastromReplicell(TM) System stem cell production
process can reduce or eliminate contaminating tumor cells which may contribute
to the long term recovery results achieved by the patients in this study,"
commented Dr. Stiff.
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 cell therapy applications. Aastrom has developed two such therapy
kits, the SC-I Therapy Kit for the production of bone marrow-derived stem cells
and the CB-I Therapy Kit for the production of cord blood 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. In addition to currently used stem cell therapies, many
emerging cell therapies are being developed at academic institutions and other
companies. The AastromReplicell(TM) System is designed to standardize these
laboratory procedures. 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 as new therapy kits for
the astromReplicell(TM) System product line.
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 developmentatements, including without
limitation, statements concerning clinical trial results, product development,
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,
unforeseen potential problems in developing new therapy kits, 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.
SOURCE Aastrom Biosciences and Loyola University Medical Center
(C) 2000 PR Newswire. All rights reserved.
prnewswire.com
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CONTACT: Todd E. Simpson, VP Finance & Administration, CFO of Aastrom
Biosciences, Inc., 734-930-5777; Mike Maggio of Loyola University Medical
Center, Director - Medical/Regional News, 708-216-3205; or media - Matthew
Knight, ext. 271, or investors - Julio Cantre, ext. 237, both of Noonan/Russo
Communications, Inc., 212-696-4455, for Aastrom Biosciences
(ASTM)
KEYWORD: Illinois
Michigan
INDUSTRY KEYWORD: MTC
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