Navigation Links
Tolera Therapeutics Granted Orphan Drug Designation for Organ Transplant Rejection Drug
Date:4/9/2009

KALAMAZOO, Mich., April 9 /PRNewswire/ -- Tolera Therapeutics, Inc., was granted orphan drug status by the United States Food and Drug Administration (FDA) for its initial lead candidate, TOL101, for prophylaxis of acute rejection of solid organ transplantation. TOL101 is a 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 this current action by the FDA," commented John J. Puisis, President and CEO of Tolera. "We are mobilized to bring TOL101 to market given the patient's need for safer and more effective immune suppression therapy. Doctors are in need of alternatives to traditional immune suppression approaches, and the current industry pipeline offers few solutions to advance patient care and meet this critical need."

The Orphan Drug Act was enacted to allow the FDA to grant a product special orphan status when it is intended to treat rare diseases or conditions -- those that affect fewer than 200,000 people annually in the United States. This special designation waives governmental filing fees, provides the drug sponsor with tax credits related to development expenses, as well as other support. In addition, orphan drug designation creates the opportunity for the sponsor to apply for orphan drug grant money from the U.S. government to help support clinical trials. As an agent with the potential to aid patients with a severe condition, TOL101 meets the stringent FDA requirements for orphan drug designation. This designation will facilitate TOL101's entry into the clinic, where relatively few new therapies have emerged over the last ten years, and there is a growing need for safer, more targeted therapeutic approaches.

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.


'/>"/>
SOURCE Tolera Therapeutics, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. First Multiple Dose Clinical Trial of TorreyPines Therapeutics Oral Compound NGX426 Demonstrates Compound Is Safe and Well-Tolerated
2. Phase 3 Data Demonstrate Efficacy and Tolerability of Paliperidone Palmitate, an Investigational Long-Acting Therapy for the Treatment of Schizophrenia
3. Parion Sciences Announces Initiation of Phase I Clinical Trial to Evaluate Safety and Tolerability of GS9411
4. Clinical Data Show Long-Acting Human Growth Hormone ARX201 is Safe and Well Tolerated
5. Laureate Pharma Announces Agreement with Tolera Therapeutics, Inc.
6. Hepatitis B Foundation and AAPCHO Sponsor Congressional Briefing on Zero Tolerance for Hepatitis B
7. Immune Tolerance Institute Appoints Aaron B. Kantor Ph.D. Chief Scientific Officer
8. The Immune Tolerance Institute Announces Collaboration with Beckman Coulter Establishing a Multiplatform Immunophenotyping/Immunogenotyping Laboratory
9. Phase I Safety and Tolerability Study With EVT 302 Successfully Completed
10. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
11. Oxygen Biotherapeutics, Inc. CEO Posts New Blog Entry
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/23/2017)... , Feb. 23, 2017  MIODx announced today ... two key immunotherapy technologies from the University of ... a method to monitor a patient for response ... and CTLA-4.  The second license extends the technology ... is likely to have an immune-related adverse event ...
(Date:2/23/2017)... TX (PRWEB) , ... February 23, 2017 , ... ... Administration (FDA) de novo clearance to begin marketing the SPEAC® System, the Brain ... for adults at home or in healthcare facilities during periods of rest. A ...
(Date:2/23/2017)... ... February 23, 2017 , ... The Greater Gift Initiative, Inc , ... Compass Research . GGI's mission is to advance global health and highlight the ... need in honor of each clinical trial volunteer. The vision of GGI is to ...
(Date:2/23/2017)... ... February 22, 2017 , ... Seventy-one members ... named Fellows of the Society this year, the Fellows Committee has announced. The ... of optics, photonics, and imaging as well as their service to the Society ...
Breaking Biology Technology:
(Date:2/8/2017)... -- Report Highlights ... The global synthetic-biology market reached nearly $3.9 billion ... at a compound annual growth rate (CAGR) of 24.0% through ... markets for synthetic biology. - Analyses of global market trends, ... compound annual growth rates (CAGRs) through 2021. - Coverage of ...
(Date:2/8/2017)... , Feb. 7, 2017 Report Highlights ... by 2021 from $8.3 billion in 2016 at a ... to 2021. Report Includes - An overview of ... market trends, with data from 2015 and 2016, and ... - Segmentation of the market on the basis of ...
(Date:2/7/2017)... WARSAW, Ind. , Feb. 7, 2017 ... global leader in musculoskeletal healthcare, will present at the ... Lotte New York Palace Hotel on Wednesday, February 15, ... A live webcast of the presentation can be accessed ... for replay following the conference via Zimmer Biomet,s Investor ...
Breaking Biology News(10 mins):