Navigation Links
Tolera Therapeutics Files IND Application for TOL101, Appoints O'Toole to Lead Clinical Operations

KALAMAZOO, Mich., Nov. 3 /PRNewswire/ -- 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

SOURCE Tolera Therapeutics, Inc.

SOURCE Tolera Therapeutics, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
2. Phase I Safety and Tolerability Study With EVT 302 Successfully Completed
3. The Immune Tolerance Institute Announces Collaboration with Beckman Coulter Establishing a Multiplatform Immunophenotyping/Immunogenotyping Laboratory
4. Immune Tolerance Institute Appoints Aaron B. Kantor Ph.D. Chief Scientific Officer
5. Hepatitis B Foundation and AAPCHO Sponsor Congressional Briefing on Zero Tolerance for Hepatitis B
6. Laureate Pharma Announces Agreement with Tolera Therapeutics, Inc.
7. Clinical Data Show Long-Acting Human Growth Hormone ARX201 is Safe and Well Tolerated
8. Parion Sciences Announces Initiation of Phase I Clinical Trial to Evaluate Safety and Tolerability of GS9411
9. Phase 3 Data Demonstrate Efficacy and Tolerability of Paliperidone Palmitate, an Investigational Long-Acting Therapy for the Treatment of Schizophrenia
10. First Multiple Dose Clinical Trial of TorreyPines Therapeutics Oral Compound NGX426 Demonstrates Compound Is Safe and Well-Tolerated
11. Tolera Therapeutics Granted Orphan Drug Designation for Organ Transplant Rejection Drug
Post Your Comments:
(Date:11/27/2015)... ... November 27, 2015 , ... Pittcon is pleased to ... presentations offered in symposia, oral sessions, workshops, awards, and posters. The core ... of applications such as, but not limited to, biotechnology, biomedical, drug discovery, environmental, ...
(Date:11/25/2015)... , November 26, 2015 ... Biobanking Market 2016 - 2020 report analyzes that ... integrity and quality in long-term samples, minimizing manual ... cost-effectiveness. Automation minimizes manual errors such as mislabeling ... efficiency. Further, it plays a vital role in ...
(Date:11/25/2015)... HOLLISTON, Mass. , Nov. 25, 2015 ... HART ), a biotechnology company developing bioengineered organ implants ... McGorry will present at the LD Micro "Main ... 2:30 p.m. PT. The presentation will be webcast live ... Management will also be available at the conference for ...
(Date:11/25/2015)... 25, 2015 Orexigen® Therapeutics, Inc. (Nasdaq: ... a fireside chat discussion at the Piper Jaffray 27th ... . The discussion is scheduled for Wednesday, December 2, ... .  A replay will be available for 14 days ... , Julie NormartVP, Corporate Communications and Business Development , ...
Breaking Biology Technology:
(Date:10/29/2015)... Oct. 29, 2015   MedNet Solutions , an ... spectrum of clinical research, is pleased to announce that ... Association (MHTA) as one of only three finalists for ... – Small and Growing" category. The Tekne Awards honor ... shown superior technology innovation and leadership. ...
(Date:10/29/2015)... 29, 2015  Rubicon Genomics, Inc., today announced ... of its DNA library preparation products, including the ... ThruPLEX Plasma-seq kit. ThruPLEX Plasma-seq has been optimized ... NGS libraries for liquid biopsies--the analysis of cell-free ... applications in cancer and other conditions. Eurofins Scientific ...
(Date:10/29/2015)... , Oct. 29, 2015 Today, ... announced a partnership with 2XU, a global leader ... deliver a smart hat with advanced bio-sensing technology. ... other athletes to monitor key biometrics to improve ... strategic partnership, the two companies will bring together the ...
Breaking Biology News(10 mins):