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:10/22/2014)... The Americas Inorganic Refrigerants Market report ... Americas with analysis and forecast of revenue. , ... Refrigerants Market report, to get an idea of ... glimpse of the segmentation in the Americas inorganic ... and figures. , http://www.micromarketmonitor.com/market/americas-inorganic-refrigerants-4191654241.html , ...
(Date:10/22/2014)... October 22, 2014 Currently offering ... A & D Weighing, Rice Lake, and Ohaus, ... Balance . The Sartorius CPA Semi-Micro Balance is ... high-quality, precise, and user-friendly laboratory balance. , Sartorius ... equipment, their laboratory balances are well known for ...
(Date:10/22/2014)... VANCOUVER , Oct. 22, 2014 /PRNewswire/ - iCo ... ICOTF), today announced next steps for its Oral ... findings from its in vitro work ... therapy.  iCo now plans to complete pre clinical ... an initial Phase 1A clinical trial, utilizing approximately ...
(Date:10/20/2014)... 2014 Mapp Biopharmaceutical,s valiant effort to ... to fight the Ebola outbreak will make the ... production of pharmaceuticals can be, according to Kalorama ... while some may be taken aback by the ... industry knowledge are well aware of the complex ...
Breaking Biology Technology:The Americas Inorganic Refrigerants Market is estimated to grow to $71.6 million by 2018 - New Report by MicroMarket Monitor 2The Americas Inorganic Refrigerants Market is estimated to grow to $71.6 million by 2018 - New Report by MicroMarket Monitor 3Pipette.com Launches the Addition of Sartorius CPA Semi-Micro Balance to Their Product Portfolio with Special Promotional Pricing 2Pipette.com Launches the Addition of Sartorius CPA Semi-Micro Balance to Their Product Portfolio with Special Promotional Pricing 3iCo Therapeutics Announces Advancement of Oral Amphotericin B Program 2iCo Therapeutics Announces Advancement of Oral Amphotericin B Program 3Kalorama: ZMapp Highlights Need For Faster Biopharmaceutical Production 2Kalorama: ZMapp Highlights Need For Faster Biopharmaceutical Production 3
... of Madison has been licensed to sell a ... agents, GenTel announced on Tuesday. , ,GenTel will market ... Kreatech Biotechnology BV of Amsterdam, under its ... are validated for use on GenTel's PATH protein microarray ...
... drive thru Illinois you now pay a premium for using cash ... device for your car. If you stop for gas at a ... plastic device on their key chain to pay for gas. These ... applications to reduce costs, improve efficiency, and potentially improve the buyers ...
... Wis. - Former Wisconsin Gov. and Secretary of ... board of directors at C.R. Bard , the ... at the company's August board meeting. , ,Bard, a ... sells specialty devices for vascular, urology, oncology and surgical ...
Cached Biology Technology:
(Date:10/17/2014)... regarding Ebola is critical and pertinent for practicing physicians ... outbreak and epidemic. The Journal, Disaster Medicine and ... Ebola Virus and Public Health, to surround the public, ... critical societal moment. , On October 17, the ... . The primer was prepared by Dr. Eric Toner, ...
(Date:10/16/2014)... wages war on the human body. Battles are ... In pancreatic cancer, this stalemate—known as tumor dormancy—can ... malignant, a phenomena that is poorly understood. ... laboratory of Salvatore Torquato, a Professor of Chemistry ... surrounding tumor dormancy and the switch to a ...
(Date:10/16/2014)... cultivated efficiently, they are anything but sustainable: environmental ... cultivation is becoming increasingly evident. Despite their disadvantages, ... are regarded as the sole possibility of achieving ... finds Bernhard Schmid, an ecology professor at the ... of agriculture and forestry. After all, a new ...
Breaking Biology News(10 mins):Modeling tumor dormancy 2Plant communities produce greater yield than monocultures 2Plant communities produce greater yield than monocultures 3
... is measured to understand tree health, fluxes in carbon ... of the most essential and widely collected woody plant ... is awkward and time consuming. Scientists have developed a ... safely and accurately. Dendrometer bands are metal straps ...
... (IL-7) is an important immune messenger protein which ensures ... in our body for immune defence. Researchers from ETH ... function: it enhances the drainage function of lymphatic vessels, ... vessels into the body tissue and return it to ...
... an old dog new tricks." Now neuroscientists are beginning to ... neuroscientists have struggled to understand how the microcircuitry of the ... for the old. New findings published in the journal ... Los Angeles and the University of California, Irvine show how ...
Cached Biology News:New technique for measuring tree growth cuts down on research time 2New technique for measuring tree growth cuts down on research time 3New function for a well-known immune messenger molecule 2New function for a well-known immune messenger molecule 3Researchers discover how inhibitory neurons behave during critical periods of learning 2
... HISTAR detection systems provide linking and ... with species specific primary antibodies for ... Visualisation is accomplished using an ultra-sensitive ... polymer labelling technology. Secondary antibodies are ...
... Enzyme concentration - 5 units/µL ,• High ... yields ,• Leaves an 'A' overhang ,• ... which exhibits very high activity in primer ... ensure the quality of the enzyme, each ...
... from Thermus aquaticus expressed in E. coli; ... of 250 units enzyme/tube and Buffer I ... the same enzyme as AmpliTaq DNA Polymerase ... separation process to ensure that contaminating bacterial ...
Our original highly-purified, robust Taq Polymerase which delivers consistently high yields and minimal background...
Biology Products: