Navigation Links
Therabron Therapeutics Receives Orphan Drug Designation in the European Union for CG367, Indicated for the Treatment of Bronchiolitis Obliterans Syndrome
Date:1/23/2017

ROCKVILLE, Md., Jan. 23, 2017 /PRNewswire/ -- Therabron Therapeutics, Inc., a clinical-stage biotechnology company dedicated to advancing a new standard in respiratory care, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products has granted Orphan Drug Designation for Therabron's CG367 program, indicated for the treatment of Bronchiolitis Obliterans Syndrome (BOS). 

"We are pleased to have received Orphan Drug Designation from the EMA to treat patients diagnosed with BOS following lung transplantation. This is an extremely serious and potentially deadly complication of lung transplantation, which generally manifests between 18 months to four years after the procedure. The condition is, unfortunately, refractory to most forms of interventions and therefore represents the most common cause of death for this patient population. We believe that CG367 holds promise as a potentially important therapeutic option and we look forward to working with the EMA as we progress clinical development for this indication," stated Vinzenz Ploerer, Chief Executive Officer of Therabron.

In addition to CG367, Therabron's lead product candidate, CG100, in development for the prevention of chronic respiratory morbidity (CRM) in premature infants, has also been granted Orphan Drug Designation by both the U.S. Food & Drug Administration and the EMA. 

About Bronchiolitis Obliterans Syndrome (BOS): BOS is a distinct complication following lung transplantation. It leads to fibrosis of airways in transplanted lungs, followed by significant functional loss, obliteration of the terminal airways and, eventually, death. Diagnosis of BOS is one of exclusion. It is made after other potentially treatable causes of obstructive lung disease have been ruled out, such as infection or acute graft rejection. In BOS, the terminal airways become increasingly obstructed, eventually being destroyed and lost. The onset of BOS varies from months to years, post-transplant, with most patients developing the condition between 18 months and four years after the procedure. Regardless, the outcome remains universally grim. The latest International Society of Heart and Lung Transplantation (ISHLT) statistics reflect the lack of meaningful advancement in the survival outcomes for those undergoing lung transplantation, with an estimated five-year survival of only 50%, making it one of the poorest survival outcomes among all solid organ transplantations performed, worldwide. Today, BOS remains the most common cause of death in lung transplant recipients who survive beyond the initial post-transplant period. Slowing the loss of lung function associated with advancing BOS could ultimately impact survival time in these patients.

About European Union (EU) Orphan Drug Designation: The European Commission grants Orphan Drug Designation status to provide incentives to develop medicinal products to treat, prevent or diagnose diseases or conditions that affect no more than five in 10,000 persons in the European Union. The Orphan Drug Designation provides Therabron with potential incentives and benefits in the EU, including protocol assistance, reduced fees and protection from market competition once CG367 is approved for BOS patients, post lung transplantation. 

About Therabron Therapeutics, Inc.
At Therabron Therapeutics, we are advancing a platform of novel therapeutic proteins in an effort to change how a variety of neglected and under-treated respiratory and fibrotic conditions are managed. We are a privately held, clinical-stage biopharmaceutical company, developing a new class of drugs based on the naturally occurring secretoglobin family of proteins, which includes the CC10 protein — a molecule with both anti-inflammatory and immunomodulatory mechanisms. Therabron's product candidates have the potential to become first-in-class biologic therapeutics. For additional information, please visit www.therabron.com.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/therabron-therapeutics-receives-orphan-drug-designation-in-the-european-union-for-cg367-indicated-for-the-treatment-of-bronchiolitis-obliterans-syndrome-300394873.html


'/>"/>
SOURCE Therabron Therapeutics, Inc.
Copyright©2017 PR Newswire.
All rights reserved


Related medicine technology :

1. Therabron Therapeutics Reaches 50 Percent Enrollment in Phase 2 Clinical Trial for Lead Pediatric Respiratory Critical Care Program
2. Therabron Therapeutics Receives Accelerated Second Tranche from Series B Financing and Expands Investor Syndicate
3. Arno Therapeutics to Present Positive, New Data Supporting the Potential of Onapristone in Endometrial and Breast Cancers at ASCO 2013 Annual Meeting
4. Novelos Therapeutics Provides Product Pipeline Update
5. Nektar Therapeutics President and CEO, Howard W. Robin, To Present at the 2013 UBS Global Healthcare Conference in New York City
6. PTC Therapeutics, Inc. Files Registration Statement for Proposed Initial Public Offering
7. Orexigen Therapeutics to Present at the UBS Global Healthcare Conference
8. Sorrento Therapeutics, Inc. announces its approach to developing human antibody therapeutics against MRSA receives continued support from the National Institute of Allergy and Infectious Diseases
9. Elcelyx Therapeutics Enrolling Phase 2b Trial of NewMet for Type 2 Diabetes
10. The Leukemia & Lymphoma Society, Valor Biotherapeutics and ImmunGene Create Partnership to Advance Novel Therapy for Non-Hodgkin Lymphoma Patients
11. Advanced Prenatal Therapeutics - Using Targeted Apheresis to Treat Preeclampsia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/22/2020)... ... 22, 2020 , ... With the new school year rapidly ... A new 8 page white paper, “Infectious Disease Control for Schools Using Germ-Fogger™”, ... Germ-Fogger™ disinfecting-fogger is uniquely well suited to the requirements of disinfecting primary school, ...
(Date:7/10/2020)... ... July 10, 2020 , ... A prominent leader in female ... Dr. Shashi Kusuma, a plastic surgeon, is introducing Cliovana to the Miami/Ft. Lauderdale/Palm ... service/treatment is a first-of-its-kind specifically focused on female arousal and pleasure and will ...
(Date:7/10/2020)... ... 09, 2020 , ... The Urgent Care Association (UCA), College of Urgent Care ... present a virtual education on acute flaccid myelitis (AFM), an uncommon but serious condition ... CT on July 14, 2020. , AFM, which is most prevalent in children, ...
Breaking Medicine Technology:
(Date:7/10/2020)... (PRWEB) , ... July 10, 2020 , ... Inversion therapy ... to stretch out the spine and relieve back pain.” Ergo, the theory is that ... are relieved while implementing traction for the spine using the head and upper body ...
(Date:7/10/2020)... SCHAUMBURG, Ill. (PRWEB) , ... July 09, 2020 ... ... for homecare, home healthcare, hospice and behavioral health announces that Ohio Department of ... Verification (EVV) vendor. , Many agencies in Ohio already rely on CellTrak ...
(Date:7/10/2020)... Calif. (PRWEB) , ... July 10, 2020 , ... ... focused on addressing unmet needs in the field of urology, today announced that ... designated as a UroLift® Center of Excellence. The designation recognizes that Dr. Meyer ...
(Date:7/7/2020)... ... , ... Mediaplanet recently launched an awareness initiative to inspire more people to ... into the spotlight and, as a result, the Bureau of Labor Statistics predicts job ... South University — which offers a Master’s in Public Health degree program both ...
(Date:7/7/2020)... ... July 07, 2020 , ... The Germ-Fogger™ ... design to efficiently sanitize large surfaces is now available in Mexico and Latin ... sales in that region. , In this era of worldwide pandemic, the ability ...
Breaking Medicine News(10 mins):