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:1/21/2017)... ... ... Nipro Corporation (Osaka, Japan) and Transonic Systems Inc. (New York, USA) announced the ... sales rights for all non-OEM Transonic products in Japan. As partners for more than ... - Transonic JV is a natural next step to advance best practices and further ...
(Date:1/21/2017)... Jan. 20, 2017 Interpace Diagnostics Group, ... that provides clinically useful molecular diagnostic tests and ... into a securities purchase agreement with three  institutional ... of common stock in a registered direct offering.  ... agreed to sell to the same investors warrants ...
(Date:1/21/2017)... 20, 2017 Aratana Therapeutics, Inc. (NASDAQ: ... the licensing, development and commercialization of innovative biopharmaceutical products ... Company in North America 2016. ... based on the FDA approval of three innovative ... ® (capromorelin oral solution) and NOCITA ® ...
(Date:1/20/2017)... ... January 20, 2017 , ... The two newest companies to join the ... Vironika, a spin out from The Wistar Institute, and Sanguis, launched by a trio ... Market Street. , Vironika is developing a treatment for a chronic viral infection ...
Breaking Biology Technology:
(Date:12/16/2016)... Research and Markets has announced the addition of the ... report to their offering. ... The biometric vehicle access system market, in terms ... from 2016 to 2021. The market is estimated to be USD ... by 2021. The growth of the biometric vehicle access system market ...
(Date:12/15/2016)... Canada and BADEN-BADEN, Germany , ... a leading global financial services provider, today announced an agreement ... passive behavioural biometrics, to join forces. The partnership will enable ... mitigation strategies in compliance with local data protection regulation. ... In order ...
(Date:12/15/2016)... DUBLIN , Dec 15, 2016 ... Research and Markets has announced ... to their offering. The report forecasts the global military ... 2016-2020. The report has been prepared based on an ... market landscape and its growth prospects over the coming years. The report ...
Breaking Biology News(10 mins):