Navigation Links
Tolera Therapeutics Granted Orphan Drug Designation for Organ Transplant Rejection Drug
Date:4/20/2009

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 medicine news :

1. Dendritic cells ensure immune tolerance
2. Exposure to Peanuts May Build Tolerance to Allergy
3. Studies show children can complete treatment for peanut allergies and achieve long-term tolerance
4. Cervical Cancer Vaccine Well Tolerated
5. Enjoy Life Foods CEO Tells FDA Grocery Stores Remain A Dangerous Minefield for Food Allergic, Food Intolerant and Celiac Shoppers
6. Internet, tolerance spark change in urban gay communities
7. African Americans at Risk for Low Calcium Intake - New Survey Finds Those Experiencing Symptoms of Lactose Intolerance May be Sidelining Dairy in Their Diets
8. Anti-HIV gel proven safe, tolerable for women
9. From Kent Hill, USAID Assistant Administrator for Global Health on the Observance of International Day of Zero Tolerance
10. Tolerate, accommodate, innovate -- how doctors deal with the risk embedded in the medical system
11. Study Shows Organons Asenapine Demonstrates Efficacy and Tolerability in Treating Acute Schizophrenia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... ... June 27, 2016 , ... "FCPX editors can now reveal their ... Cut Pro X," said Christina Austin - CEO of Pixel Film Studios. , ... Pro X users can now reveal the media of their split screens with ...
(Date:6/27/2016)... , ... June 27, 2016 , ... TopConsumerReviews.com recently awarded ... Eyeglasses . , Millions of individuals in the United States and Canada wear ... a way to both correct vision and make a fashion statement. Even celebrities use ...
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements owned by ... to enhance the health of felines. The formula is all-natural and is made from ... the PawPaws Cat Kidney Support Supplement Soft Chews are Astragalus Root Extract ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs ... College of Mohs Surgery and to Dr. Russell Peckham for medical and surgical dermatology. ... treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, Dr. ... his M.D from the David Geffen School of Medicine at UCLA. He trained in ... to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... -- Research and Markets has announced the addition ... to their offering. The ... commercial environment for MedImmune to enter. The US ageing population ... to drive considerable growth for effective anti-influenza medications. The introduction ... considerably, but development is still in its infancy. ...
(Date:6/23/2016)... and INDIANAPOLIS , June 23, ... a Lilly Diabetes Tomorrow,s Leaders Scholarship is any indication, ... winners, announced today online at www.diabetesscholars.org by ... 1 diabetes stand in the way of academic and ... the Foundation,s scholarship program since 2012, and continues to ...
(Date:6/23/2016)... PRINCETON, N.J. , June 23, 2016  Guerbet ... of Premier Inc.,s Supplier Horizon Award . ... this year, Guerbet was recognized for its support of ... value creation through clinical excellence, and commitment to lower ... delighted to receive this recognition of our outstanding customer ...
Breaking Medicine Technology: