Tolera’s lead drug candidate TOL101 to be
investigated for immune modulation in Department of Defense AFIRM program
Wednesday, April 1, 2009 -
Tolera Therapeutics, Inc., a biotechnology company focusing on the development
of immunotherapeutics, will have its lead drug candidate, TOL101, investigated
under a new Department of Defense research initiative, the Armed Forces
Institute for Regenerative Medicine (AFIRM). As part of the research funded by
the AFIRM -- which has the mission to develop improved therapies to treat
wounded warriors -- Dr. Maria Siemionow of the Cleveland Clinic will undertake
to use TOL101 to reduce or eliminate immunosuppression therapy and facilitate
composite tissue reconstruction and transplantation surgeries.
Composite tissue transplantation is a promising
procedure for the treatment of facial or extremity injury. In this
therapy, tissue (which may include skin, muscle, bone, nerves and blood vessels)
is surgically transplanted from a donor to a patient to replace severely damaged
or missing tissue. These procedures have historically been complicated by
the need for strong immunosuppression therapies to avoid the recipient patient’s
rejection of the transplanted tissue. TOL101, a biologic protein, is designed
to safely and specifically target T cells, the cells most responsible for immune
system-mediated rejection. Dr. Siemionow, a highly regarded expert best known as
the surgeon who led the Cleveland Clinic team that performed the first
US
facial transplant, will lead the initial TOL101 composite tissue study.
While initial patients under FDA-approved study will
be kidney transplant recipients, Dr. Siemionow regards the TOL101 antibody as an
improved therapeutic alternative to existing therapies. “Immunosuppression
therapy can be difficult for all transplant patients, but for patients receiving
composite transplants, we have to be even more careful, because of the tissues
involved”, said Dr. Siemionow, “We are optimistic that TOL101 can make a
difference for these patients in particular.”
About Tolera Therapeutics: Building
upon research done at the University of Kentucky and the Cleveland Clinic,
Tolera Therapeutics is developing and commercializing therapies for the immune
suppression / modulation market with the goal of addressing unmet medical needs
with safer, more targeted solutions to reduce the risk of serious and toxic side
effects often associated with immunotherapy. The company is focusing on
commercializing a therapeutic monoclonal antibody for the transplantation and
autoimmune markets. Additional information concerning the company and its
technology can be found on its website
www.tolera.com.
About AFIRM: In April of 2008, the
Department of Defense announced the establishment of the AFIRM (Armed Forces
Institute of Regenerative Medicine), a multi-institutional network for the
purpose of funding and guiding research in the field of regenerative medicine.
In partnership with the US Army Institute of Medical Research, the AFIRM is
comprised of two consortia, one led by Rutgers and the Cleveland Clinic, the
other by Wake
Forest
University
and the McGowan Institute. Each consortium is made up of many institutions from
across the United States,
allowing the AFIRM program to partner with top clinicians and researchers in
fields related to regenerative medicine. The goal of the AFIRM is to accelerate
the development and deployment of new therapies for burn repair, wound healing,
limb and facial tissue transplantation, reconstruction, and regeneration. In
addition to benefiting wounded soldiers, the research being undertaken in the
AFIRM project will benefit civilians in need of regenerative therapies in the
wake of severe injuries related to accident or illness. More than $250 million
from defense funding, other governmental agencies, academic institutions, and
industry has been made available for research for the next 5 years under the
AFIRM program.
Company
contact:
James Herrmann
(269) 585-2100
info@tolera.com
