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:5/18/2016)... ... May 18, 2016 , ... Shimadzu Scientific ... The University of Toledo. This two-day camp will take place annually starting June ... field of pharmaceutical sciences in preparation for a university academic program. , ...
(Date:5/18/2016)... ... 18, 2016 , ... Every day, more than 5,400 ER ... Costing more than $56 billion in direct costs annually, asthma remains a critical ... the suffering associated with uncontrolled asthma can be overwhelmingly disproportionate and better managed,” ...
(Date:5/17/2016)... May 18, 2016 Haselmeier announces ... pen following approval by EMA, the European Medicines Agency. ... and technology company, the new pen version includes enhancements ... level of confidence to patients during use. ... pen easier to handle with a larger display window ...
(Date:5/17/2016)... ... 2016 , ... PATH and Laerdal Global Health announced today ... feeding cup to market based on a reference design co-developed by PATH, the ... Hospital, thereby ensuring an innovative feeding option for the 7.6 million preterm infants ...
Breaking Biology Technology:
(Date:4/19/2016)... , UAE, April 20, 2016 ... be implemented as a compact web-based "all-in-one" system solution ... the biometric fingerprint reader or the door interface with ... of modern access control systems. The minimal dimensions of ... ID readers into the building installations offer considerable freedom ...
(Date:4/15/2016)... 15, 2016 Research and ... Biometrics Market 2016-2020,"  report to their offering.  , ... , ,The global gait biometrics market is expected ... the period 2016-2020. Gait analysis generates ... be used to compute factors that are not ...
(Date:4/13/2016)... 13, 2016  IMPOWER physicians supporting Medicaid patients in ... new clinical standard in telehealth thanks to a new ... higi platform, IMPOWER patients can routinely track key health ... mass index, and, when they opt in, share them ... to a local retail location at no cost. By ...
Breaking Biology News(10 mins):