Vasogen Inc. INVESTOR CONTACT
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Mississauga, ON, Canada L5L 4M1 Investor Relations
tel: (905) 569-2265 fax: (905) 569-9231 (905) 569-9065
www.vasogen.com [email protected]
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FOR IMMEDIATE RELEASE
Vasogen Results Accepted for Publication in Transplantation
Toronto, Ontario (November 21, 2000) -- Vasogen Inc. (TSE:VAS; AMEX:MEW) today
announced that the medical journal, Transplantation, has accepted for
publication results of pre-clinical research demonstrating the ability of its
proprietary VAS981 cell-processing technology to prevent graft-versus-host
disease (GvHD). These results formed the basis for the Company's clinical study
in leukemia patients at the Princess Margaret Hospital, Toronto, under the
direction of Dr. Hans Messner, Director, Bone Marrow Transplant Program. GvHD is
the major limiting factor in providing life-saving bone marrow transplantation
to thousands of patients suffering from leukemias and lymphomas.
Transplantation is the official peer-reviewed journal of the Transplantation
Society, which was founded in 1966 to provide a common forum for physicians and
basic scientists involved in transplantation. The results to be published in
December include data from pre-clinical research conducted at the Division of
Cancer Biology Research, Sunnybrook Health Sciences Centre, University of
Toronto, under the direction of Dr. David Spaner. The study was designed to
investigate the ability of VAS981, compared with standard immunosuppression
therapy, an anti-TNF agent or untreated controls, to prevent GvHD in two
pre-clinical animal models in which T cells (the cells required to reconstitute
the patient's bone marrow) were transplanted from a genetically unrelated donor.
In the first pre-clinical model of GvHD, transplantation of untreated T cells
resulted in GvHD and death of 60% of the animals, whereas there was no evidence
of GvHD in animals receiving VAS981-treated T cells. The protection by VAS981
was associated with a normalization of the imbalance between CD8 and CD4 T cells
seen in GvHD. In a second pre-clinical model of severe GvHD, transplantation of
untreated T cells resulted in fatal GvHD in all animals within two weeks. Groups
of animals that received either cyclosporine, an immunosuppressant drug widely
used to treat GvHD, or an anti-TNF agent, both developed GvHD and all animals
died within three weeks following transplantation. However, in the group of
animals in which the donor T cells were treated with VAS981 prior to
transplantation, 50% of the animals survived for the duration of the study (20
weeks). These results suggest that the clinical utility of the VAS981
cell-processing technology may even extend to transplant situations where there
are no appropriately matched bone marrow donors and the risk of the patient
developing life-threatening GvHD is extremely high - thus offering a potential
therapeutic option for patients for whom none currently exists.
In addition to these pre-clinical studies that are the subject of the
publication, separate laboratory research investigated the effects of the VAS981
cell-processing technology on human T cells that are administered in bone marrow
grafts and are the cause of GvHD. The results showed that VAS981-treated cells
produced much lower levels of the inflammatory cytokines that are associated
with
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GvHD. The in vitro changes seen in these laboratory studies on human T cells
closely mirrored those seen in vivo in the pre-clinical studies, where they were
associated with a dramatic reduction in GvHD.
Graft-versus-host disease develops as part of an immune response that occurs
when T cells, given with the donated bone marrow (graft), identify cells in the
recipient's body (host) as foreign and reject them, leading to severe
complications, which may be fatal. Thousands of bone marrow transplant
procedures are performed annually. Nearly half of the cancer patients who
receive bone marrow transplants develop graft-versus-host disease. Costs
associated with treating complications of this disease are estimated $400
million annually.
Vasogen is focused on developing immune modulation therapies to advance the
treatment of cardiovascular, autoimmune and related inflammatory diseases. These
therapies are designed to target fundamental disease-causing events, providing
safe, effective treatment.
Statements contained in this press release, including those pertaining to
scientific and clinical research, commercialization plans, strategic alliances,
and intellectual property protection, other than statements of historical fact,
are forward-looking statements subject to a number of uncertainties that could
cause actual results to differ materially from statements made.
