Navigation Links
Tolera Therapeutics Granted Orphan Drug Designation for Organ Transplant Rejection Drug

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

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:
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... Pixel Film ... Pro X. , "Film editors can give their videos a whole new perspective by ... Austin - CEO of Pixel Film Studios. , ProSlice Levels contains over 30 ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many women are confused ... endometriosis. These women need a treatment plan to not only alleviate symptoms and ... help for preservation of fertility and ultimately achieving a pregnancy. The specialists at ...
(Date:6/25/2016)... ... ... of Bruton Memorial Library on June 21 due to a possible lice infestation, as reported ... head lice: the parasite’s ability to live away from a human host, and to infest ... in the event that lice have simply gotten out of control. , As lice are ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, Dr. Omkar ... M.D from the David Geffen School of Medicine at UCLA. He trained in Internal ... complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits ... terms of the latter, setting the bar too high can result in disappointment, perhaps ... slow progress toward their goal. , Research from reveals that ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , , , WHEN: , , ... , , , LOCATION: , , , Online, with free registration ... PANELISTS:  , , , Frost & Sullivan,s Global Vice President of ... Analyst, Divyaa Ravishankar and Unmesh Lal, Program Manager , ... witnessing an exceptional era. Several new demand spaces, such as innovative ...
(Date:6/23/2016)... Revolutionary technology includes multi-speaker listening ... industry leaders in advanced audiology and hearing aid technology, ... ™, the world,s first internet connected hearing aid that ...      (Photo: ) , ... ,world firsts,: , TwinLink™ - the first ...
(Date:6/23/2016)... Research and Markets has announced ... Analysis (United States, China, Japan, Brazil, United Kingdom, Germany, ... offering. Surgical Procedure ... planners, provides surgical procedure volume data in a geographic ... in-depth analysis of growth drivers and inhibitors, including world ...
Breaking Medicine Technology: