Navigation Links
Shire Regenerative Medicine Initiates Phase 3 Study of ABH001 for Patients with Epidermolysis Bullosa
Date:2/8/2013

SAN DIEGO, February 8, 2013 /PRNewswire/ --

Shire plc (LSE: SHP, NASDAQ: SHPG), today announced the initiation of a Phase 3 study designed to evaluate the efficacy and safety of ABH001, its dermal substitute therapy, for the treatment of non-healing wounds in patients with Epidermolysis Bullosa (EB), a group of rare genetic skin disorders that begin to manifest at birth or early childhood and occur in approximately 19 per 1 million live births in the US. [i]  

"People affected by EB suffer skin blisters and almost constant, acute pain and scarring," said the study's Principal Investigator, H. Alan Arbuckle , MD, Section Head Pediatric Dermatology Kaiser Permanente Colorado, Wound Care Consultant, Epidermolysis Bullosa Center of Excellence, The Children's Hospital, Aurora Colorado . "The current standard of care is daily wound care, bandaging and pain management. I am excited to be involved in testing the efficacy and safety of ABH001 as a potential treatment option for these patients."  

ABH001 for EB has been granted an orphan drug designation in the US and EU, and has also received Fast Track designation from the US Food and Drug Administration (FDA), which is aimed at facilitating the development and expediting the review of drugs and biologics that fill an unmet medical need. In addition, the European Medicines Agency's Pediatric Committee has agreed on a pediatric investigation plan for ABH001 for the treatment of EB.

The new Phase 3 study is a multi-site, prospective, randomized, open-label, intra-subject controlled trial evaluating the efficacy and safety of ABH001 to initiate healing and reduce the wound surface area of selected stalled, chronic cutaneous wounds associated with generalized EB. Approximately 20 subjects with generalized EB age
'/>"/>

SOURCE Shire plc
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related biology technology :

1. Shire to Acquire FerroKin BioSciences, Inc., and its Phase 2 Iron Chelator Treatment
2. Heptares Grants Shire an Exclusive Worldwide Licence to Develop and Commercialise Novel Drug Candidate for CNS Disorders
3. Shire plc: First Quarter 2012 Results Date Notification - April 26, 2012
4. Shire Facebook Page Increases Awareness of Hereditary Angioedema (HAE) in Support of First HAE Awareness Day May 16th
5. Berkshire Corporation Offers Live Chat For Americas Website and Shopping Cart
6. Shire Changes its NASDAQ Ticker Symbol to SHPG
7. Dr. Jeff Jonas Appointed President of Shire Regenerative Medicine Business and Joins Shire Leadership Team
8. Shire and Boston Childrens Hospital Enter Into Broad Research Collaboration
9. Shire Reaches Agreement in Principle With U.S. Government
10. Palm Beach Residents to Learn How the Future of Regenerative Medicine Will Combat Aging
11. ODT Forum Presents Regenerative Technologies
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/23/2014)... (PRWEB) July 23, 2014 OncLive® ... Cancer Center has joined its Strategic Alliance Partnership ... Alliance Partnership program, UNC Lineberger will have the ... raise awareness of its cutting-edge research initiatives, community-directed ... UNC Lineberger will work with OncLive to educate ...
(Date:7/22/2014)... Web) July 21, 2014 (PRWEB) July 23, 2014 ... Biomaterials, at Rutgers University. , The goal ... ideas across the full spectrum of scientists working ... research and development topics that represent the most ... been programmed to:,     Provide faculty ...
(Date:7/22/2014)... of rod-shaped metal nanoparticles in water with ultrasound and ... bits. Why? No one yet knows exactly. But researchers ... have clocked their speedand it,s fast. At up to ... faster than any nanoscale object submerged in liquid ever ... opened up the possibility that they could be used ...
(Date:7/22/2014)... CTD Holdings, Inc. (OTCQB:CTDH), a manufacturer ... cosmetics, and other markets, announced today that it has ... qualified private investors led by Novit L.P., an investment ... transaction involved the signing of a Securities Purchase Agreement ... Stock at a price per share of $1.00, resulting ...
Breaking Biology Technology:OncLive Expands Its Strategic Alliance Partnership Program With the Addition of UNC Lineberger Comprehensive Cancer Center 2OncLive Expands Its Strategic Alliance Partnership Program With the Addition of UNC Lineberger Comprehensive Cancer Center 3The 2014 NJ Symposium on Biomaterials Science Earns Society for Biomaterials Endorsement 2NIST shows ultrasonically propelled nanorods spin dizzyingly fast 2CTD Holdings Closes $1.725 Million Private Placement 2CTD Holdings Closes $1.725 Million Private Placement 3
... ST. LOUIS and RICHMOND, Calif., Oct. 5 ... BioSciences, Inc. (Nasdaq: SGMO ) today announced ... to include the exclusive rights to develop and ... lines for commercial production of protein pharmaceuticals. ...
... ... 2009, Munich) free white paper on Organic Electronics that discusses rfid tags, OLED, AM ... ... has just published a white paper that discusses the current state of the organic ...
... of Eindhoven University of Technology and the Radboud University ... why ordinary graphite is a permanent magnet at room ... nanotechnology, such as sensors and detectors. In particular graphite ... The results will appear online on 4 October in ...
Cached Biology Technology:Sigma-Aldrich(R) and Sangamo BioSciences Announce Major Expansion of ZFP Technology License Agreement 2Sigma-Aldrich(R) and Sangamo BioSciences Announce Major Expansion of ZFP Technology License Agreement 3Sigma-Aldrich(R) and Sangamo BioSciences Announce Major Expansion of ZFP Technology License Agreement 4Free Organic Electronics White Paper Discusses Rfid Tags, OLED, AM OLED, PM OLED, Electroluminescence, e-Paper, OE Market Forecast 2Graphite mimics iron's magnetism 2
(Date:7/23/2014)... , July 23, 2014 BioCatch, ... detection, announced today it has been named in Gartner,s ... Market Guide replaces Gartner,s well-known Magic Quadrant for Web ... BioCatch as one of several vendors to deliver passive ... will become a standard feature of at least 30% ...
(Date:7/23/2014)... bacterial group called SUP05 will play an increasingly important ... oceans as oxygen minimum zones expand, according to research ... National Academy of Sciences . , University of British ... fjord, Canada,s Saanich Inlet, to chart how microbial community ... study paints a very detailed picture of how SUP05 ...
(Date:7/23/2014)... MINNETONKA, Minn. , July 23, 2014 /PRNewswire/ ... technology company specializing in clinical study management systems, ... West , a proven life sciences industry executive ... named Chief Operating Officer (COO).  Clareece will be ... and sales growth, operational efficiency and quality product/service ...
Breaking Biology News(10 mins):BioCatch Featured in Gartner's 2014 Online Fraud Detection Market Guide 2BioCatch Featured in Gartner's 2014 Online Fraud Detection Market Guide 3Research charts the ecological impact of microbial respiration in the oxygen-starved ocean 2MedNet Appoints Clareece West As Chief Operating Officer 2
... the heritable disorder of the skin called Gorlin syndrome ... of the skin may have a new chemoprevention therapy ... a placebo-controlled, randomized, double-blind, Phase II study, the use ... basal cell carcinomas in a relatively rare group of ...
... have gleaned a key insight into the molecular beginnings of ... in the elderly, by determining how two key proteins interact ... a paper to be published in a forthcoming issue of ... for the first time how a common blood protein linked ...
... and two together in a study that will likely yield ... impact corn will be examined by two researchers hoping to ... level. Drought tolerance and aflatoxin resistance are the targets ... been awarded a $500,000 grant for the project by the ...
Cached Biology News:Celebrex inhibited the burden of skin cancer in high-risk patients 2New research findings may help stop age-related macular degeneration at the molecular level 2Genes for drought-tolerance, aflatoxin may mingle to boost corn production 2
... Each kit contains sufficient materials for 1,464 array ... Nitrocellulose Membrane: 4 each , Blocker BSA in PBS ... , BupH Phosphate Buffered Saline: 8 packs , 10% ... Pico Luminol Enhancer: 2 x 25 ml , SuperSignal ...
... system, 100-120 V, is used for biolistic ... handheld device employs an adjustable helium pulse ... gold microcarriers from the inner wall of ... cells. This system has a 2 square-centimeter ...
... raised against a partial recombinant ... ZFHX4 (NP_078997, 2 a.a. ... protein with GST tag. ... NM_024721 Protein ...
... Mouse polyclonal antibody raised against ... Immunogen: K6HF ... a.a) partial recombinant protein with ... Accession Number: NM_004693 ...
Biology Products: