Navigation Links
FDA grants cardiotrophin-1 Orphan Drug status for acute liver failure treatment to Digna Biotech
Date:9/21/2011

Digna Biotech, a Spanish biotechnological company, announces that the Food and Drug Administration (FDA) granted cardiotrophin-1 (CT-1) Orphan Drug status for use in the treatment of acute liver failure (Designation request 11-3507).

This provides more incentives to work on cures for this disease, which has an incidence of 2,000 cases per year in the United States, according to the findings reported by Acute Liver Failure Study Group (ALFSG) (Lee, Squires et al. 2008). In August, the European Medicine Agency (EMA) granted also the Orphan Drug status of cardiotrophin-1 for the treatment of acute liver failure (EU/3/11/893).

Pablo Ortiz, CEO at Digna Biotech, commented, "The experimental findings that support this new indication of CT-1 are very strong and we are confident that they can be converted in a clinical valuable effect in patients suffering from acute liver failure of different etiology. Acute liver failure is a very severe condition with a high mortality rate and very limited therapeutics possibilities that needs effective treatments. The advantage of having the product at the clinical stage starting Phase I allow us to plan Phase II for this indication by the end of next year."

Acute liver failure is a rare disease that is manifested by a sudden loss of the normal liver functions in a patient with a previously normal liver and without evidence of chronic liver disease. The most common first sign of liver failure is yellowing of the skin (jaundice). This condition has serious complications such as bruising and bleeding due to impaired blood clotting as well as cerebral edema (swelling around the brain), convulsions (fits) and coma. The most common causes of acute liver failure are toxic damage (e.g. alcohol and drugs such as paracetamol) or viral hepatitis (an infectious disease that affects the liver). Acute liver failure is a long-term debilitating and life-threatening disease because of its damaging effects on the brain and other organs.

Cardiotrophin-1 is a naturally occurring chemical messenger in the blood that has antioxidant (a molecule that prevents the oxidation of other molecules) and anti-inflammatory properties. Liver cells actively produce cardiotrophin-1 as part of the defense mechanism against injury. The medicine is expected to work the same way as naturally occurring cardiotrophin-1 by acting as a messenger to the damaged liver cells, helping them to recover and restoring their function. The effects of cardiotrophin-1 have been evaluated in experimental models.

Cardiotrophin-1 is co-developed for its use in organ transplantation and tissue regeneration by Digna Biotech and Biotecnol (The Consortium). Both of the companies signed an Exclusive License and Option Agreement with Genentech, Inc. (a fully owned subsidiary of the Roche Group) in September 2009. Pre-clinical and clinical development of cardiotrophin-1 was funded by a number of private and public entities in Spain: ClaveSuan, the Center for Industrial and Technological Development (CDTI), and the Government of Navarra. Only in liver resection and transplantation, cardiotrophin-1 may generate revenues of 350 million of euros per year.


'/>"/>
Contact: Nuria Safont
nsafont@dignabiotech.com
Digna Biotech S.L
Source:Eurekalert

Related biology news :

1. EPA grants help Wayne State researchers stave off Great Lakes environmental invaders
2. CWRU School of Dental Medicine receives $2.6 million in grants
3. Lincoln Park Zoo awarded 2 significant grants for science education
4. Grants awarded to help bring promising bioscience discoveries to market
5. American Health Assistance Foundation announces latest grants for innovative vision research
6. S.L.E. Lupus Foundation announces new grants to further NYC scientists leadership in lupus research
7. Altitude Research Center wins major Pentagon grants
8. Pancreatic Cancer Action Network-AACR Pathway to Leadership Grants awarded to early-career investigators
9. Scientists awarded carcinoid tumor and pancreatic neuroendocrine tumor research grants
10. $38.4M NHMRC program grants extend cancer and blood cell research
11. NIFA announces grants to study the effects of climate change on agricultural and forest production
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/22/2016)... On Monday, the Department of Homeland Security (DHS) issued ... the Biometric Exit Program. The Request for Information (RFI), ... that CBP intends to add biometrics to confirm when ... , in order to deter visa overstays, to ... Logo - http://photos.prnewswire.com/prnh/20160622/382209LOGO ...
(Date:6/15/2016)... , June 15, 2016 ... market report titled "Gesture Recognition Market by Application Market - Global ... 2016 - 2024". According to the report, the  global ... billion in 2015 and is estimated to grow ... 48.56 billion by 2024.  Increasing application ...
(Date:6/3/2016)... Das DOTM (Department ... hat ein 44 Millionen $-Projekt ... einschließlich Personalisierung, Registrierung und IT-Infrastruktur, an Decatur ... Implementierung von Identitätsmanagementlösungen. Zahlreiche renommierte internationale Anbieter ... aber Decatur wurde als konformste und innovativste ...
Breaking Biology News(10 mins):
(Date:6/23/2016)... June 23, 2016 ... 2016;12(1):22-8 http://doi.org/10.17925/OHR.2016.12.01.22 Published recently ... peer-reviewed journal from touchONCOLOGY, Andrew D Zelenetz ... of cancer care is placing an increasing burden ... expensive biologic therapies. With the patents on many ...
(Date:6/23/2016)... ... June 23, 2016 , ... ClinCapture, the only ... Center and will showcase its product’s latest features from June 26 to June ... scientific poster on Disrupting Clinical Trials in The Cloud during the conference. ...
(Date:6/23/2016)... ... June 23, 2016 , ... Velocity Products, ... tools designed, tuned and optimized exclusively for Okuma CNC machining centers at The ... of a collaboration among several companies with expertise in toolholding, cutting tools, machining ...
(Date:6/23/2016)... , June 23, 2016 ... research report to its pharmaceuticals section with historic ... details and much more. Complete report ... 151 pages, profiling 15 companies and supported with ... http://www.reportsnreports.com/reports/601420-global-cell-culture-media-industry-2016-market-research-report.html . The Global ...
Breaking Biology Technology: