Tolera Therapeutics files IND application for TOL101,
appoints O’Toole to lead clinical operations
Kalamazoo, Michigan, Tuesday, Nov. 3, 2009
– Tolera Therapeutics, Inc., announced it has filed an
Investigational New Drug (IND) application with the United States Food and Drug
Administration (FDA) for its lead candidate, TOL101, for prophylaxis of acute
rejection of solid organ transplantation. TOL101 is a novel biologic protein
that is designed to safely and specifically target T cells, components of the
immune system that play a key role in the rejection, and ultimate failure, of
transplanted organs. Organ transplantation is often the only viable treatment
for many end-stage organ diseases.
“We are extremely pleased with our progress toward bringing
TOL101 to the clinic.” commented John J. Puisis, President and CEO of Tolera.
“This action marks an important development milestone as the company continues
its drive to address the patient’s need for safer and more effective immune
suppression therapy. Current industry practices and pipelines offer limited and
incomplete solutions to advance patient care and meet this critical need.
Pending acceptance by the FDA, we intend to conduct clinical studies starting in
2010.”
Tolera also announced the appointment of Leslie O’Toole to
lead its clinical operations as Director, Clinical Programs. O’Toole brings
over 20 years of industry experience with 16 years focusing on clinical research
management. Mr. Puisis added “We’re excited about adding Leslie to our dynamic
team. Her depth of clinical research experience adds an important operating
aspect to the organization and positions us for continued success.” Prior to
joining the company, O’Toole was Director, Project Management at Clinimetrics, a
full service contract research organization where she was involved in over 35
studies researching drugs in numerous indications with a primary focus in
oncology and immunology.
About Tolera Therapeutics:
Tolera Therapeutics is a Kalamazoo, Michigan based biotechnology company and a
spin-off of the Cleveland Clinic Foundation. Primary investors in the company
include Southwest Michigan First Life Sciences Fund, Triathlon Medical Venture
Partners, Hopen Therapeutics and the Michigan Economic Development Corporation.
Building upon research done at the University of Kentucky and the Cleveland
Clinic, Tolera Therapeutics is developing and commercializing therapies for the
immune 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 therapeutic monoclonal antibody technology for the
transplantation and autoimmune markets. Additional information concerning the
company and its technology can be found on its website
www.tolera.com.
Company
contact:
James Herrmann
(269) 585-2100
info@tolera.com
