Navigation Links
Angiotech elects to suspend Vascular Wrap(TM) pivotal clinical trials
Date:4/21/2008

VANCOUVER, April 21 /PRNewswire-FirstCall/ - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP), a global specialty pharmaceutical and medical device company, today announced that it has elected to suspend enrolment in its U.S. and EU human clinical trials for its Vascular Wrap product candidate in patients undergoing surgery for hemodialysis access, pending a safety review to evaluate an imbalance of infections that have been observed between the two study groups. The U.S. and EU trials each consist of two study groups; (1) patients who received the graft/Vascular Wrap combination; and, (2) patients who received the graft alone.

At the onset of this study Angiotech established an independent Data Safety Monitoring Board (DSMB) in the U.S. to monitor any unexpected risks or safety issues. Angiotech recently submitted a safety summary of adverse events from the U.S. clinical trial to the DSMB, based upon having reached the 25% enrolment threshold in the U.S. clinical trial. Subsequent to that submission, Angiotech received a communication from the DSMB that one of the study groups had a greater incidence of implant site infection in comparison with the other study group. Angiotech is blinded to the groups and not currently aware of whether the increased rate of infection is in the patient group that received the graft/Vascular Wrap combination or in the patient group that received the graft alone. As a result of these observations, Angiotech has elected to notify physicians to suspend further enrolment in the trials, pending a full review of the potential cause of the implant site infections.

"We regard patient safety as the paramount obligation of any company in our industry, and upon further adjudication of the clinic
'/>"/>

SOURCE Angiotech Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. Angiotechs Corporate Partner, Boston Scientific, Reports Canadian Approval for TAXUS(R) Liberte(R) Stent System
2. Angiotechs novel 5-FU Central Venous Catheter receives FDA 510(k) clearance
3. Angiotech announces director resignation
4. Angiotech announces commercial launch of Cook Medicals Zilver(R) PTX(TM) drug-eluting peripheral stent in New Zealand
5. Angiotech to participate in Credit Suisse Global Leveraged Finance Conference
6. 960-Patient Study Demonstrates Zero Blood Stream Infection In Patients Treated With Angiotechs Novel 5-FU Central Venous Catheter
7. Angiotech to participate in Lehman Brothers Healthcare Conference
8. Angiotech announces filing of audited financial results for the year ended December 31, 2007 and restatement of results for the year ended December 31, 2006
9. Angiotech and Rex Medical announce exclusive licensing and distribution agreement for the "Option(TM)" inferior vena cava filter
10. Angiotech showcases its Hemostream(TM) Dialysis Catheter at the Society of Interventional Radiology (SIR) Annual Meeting
11. Angiotech announces results for the fourth quarter ended December 31, 2007
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/19/2013)... Express Diagnostics Int’l, Inc., manufacturer of ... it has received Class III medical device license approval ... DrugCheck® NxStep Onsite Drug Screen Cup in Canada. ... device in near-patient settings, such as physicians’ offices. , ... Canada Class III approval for 24 different drugs and ...
(Date:6/18/2013)... In support of Swiss contributions to scientific ... Switzerland in New York is pleased to welcome the ... , to Manhattan. PlanetSolar is in New York ... with scientists on board from the University of Geneva. ... on energy from the sun and eliminates the need ...
(Date:6/18/2013)... DuPont welcomes 48 of the nation’s finest agricultural ... Teachers Ambassador Academy this week (NATAA) at the company’s ... , The NATAA “Ag Academy” is a professional development ... of the National FFA Foundation and the ... The highly recommended agriscience teachers, who are participating in ...
(Date:6/18/2013)... June 18, 2013 ... research firm, announces the initiation of full ... biopharmaceutical company developing and marketing products for ...      (Logo: http://photos.prnewswire.com/prnh/20130417/608168) ... examining the investment merits of BioAlliance Pharma, ...
Breaking Biology Technology:Express Diagnostics’ DrugCheck® On-site Test Cup Receives Health Canada Class III Medical Device Approval 2Express Diagnostics’ DrugCheck® On-site Test Cup Receives Health Canada Class III Medical Device Approval 3Switzerland’s MS Tûranor PlanetSolar, the World’s Largest Solar Boat, Arrives in New York City 2Switzerland’s MS Tûranor PlanetSolar, the World’s Largest Solar Boat, Arrives in New York City 3Switzerland’s MS Tûranor PlanetSolar, the World’s Largest Solar Boat, Arrives in New York City 4DuPont Sponsors National AgriScience Ambassador Academy 2DuPont Sponsors National AgriScience Ambassador Academy 3Edison Expands French Healthcare Sector Coverage With Initiation of Coverage on BioAlliance Pharma 2Edison Expands French Healthcare Sector Coverage With Initiation of Coverage on BioAlliance Pharma 3
... -- Sinovac Biotech Ltd. (Nasdaq: SVA ), ... today that Mr. Jacob Ho, Acting Chief Financial Officer, ... Yang, Investor Relations Manager, are scheduled to present at ... November. Goldman Sachs China Investment Frontier ...
... Mass., Oct. 26 Idenix Pharmaceuticals, Inc. (Nasdaq: ... corporate overview at the Oppenheimer & Co. 21st Annual Healthcare ... at the Waldorf Astoria, New York City. ... be accessed under "Calendar of Events" in the Idenix Investor ...
... YORK, Oct. 26 Signal Genetics, the parent company ... company focused on oncology, today announced the formation of ... Kenneth Anderson, M.D. Director, Jerome Lipper ... Family Professor of Medicine, Harvard Medical School ...
Cached Biology Technology:Sinovac Participates in Two Investor Conferences in November 2Signal Genetics Announces Establishment of Scientific Advisory Board 2Signal Genetics Announces Establishment of Scientific Advisory Board 3
(Date:6/18/2013)... $12.7 million to match nine academic research groups ... explore new treatments for patients in eight disease ... schizophrenia. The collaborative pilot initiative, called Discovering New ... the National Center for Advancing Translational Sciences (NCATS) ... The process of developing a new therapeutic is ...
(Date:6/18/2013)... 2013 The herbal extract of a yellow-flowered mountain ... increase the lifespan of fruit fly populations by an ... , But it,s how Rhodiola rosea ... grabbed the attention of study leaders Mahtab Jafari and ... in a manner completely unrelated to dietary restriction and ...
(Date:6/18/2013)... internationally recognized feline experts including veterinarians and feline scientists ... Lincoln, U.K. and Dr Ilona Rodan, Director of Cat ... Society of Feline Medicine (ISFM) and the American Association ... owners and those working with cats on how to ... new guidelines appear in the Journal of Feline ...
Breaking Biology News(10 mins):NIH to fund collaborations with industry to identify new uses for existing compounds 2NIH to fund collaborations with industry to identify new uses for existing compounds 3NIH to fund collaborations with industry to identify new uses for existing compounds 4Herbal extract boosts fruit fly lifespan by nearly 25 percent, UCI study finds 2Feline behavior experts release guidelines to improve the welfare of cats 2
... connections between nerve cells in the brain can be regulated ... from UC Davis. The research, published Feb. 27 in the ... between immunity, infectious disease and conditions such as schizophrenia or ... with changes in connectivity in the brain, said Kimberley McAllister, ...
... left us with vivid images of the grasshopper plagues ... commonly referred to as grasshoppers, the infestations were actually ... became extinct in 1902, but their cousins, grasshoppers and ... (2005 U.S. dollars) in damage to grazing lands in ...
... 25, 2011 The threat of counterfeit documents ... and optical scanners have made it easy for ... checks among many types of documents.  It has ... be able to detect fraudulent bank checks.  Additionally, ...
Cached Biology News:Immune molecule regulates brain connections 2Notre Dame research offers important clues about grasshopper population explosions 2Advanced Protection Against Document Fraud - ICAP Ocean Tomo Announces Auction of a Counterfeit Document Detection System 2Advanced Protection Against Document Fraud - ICAP Ocean Tomo Announces Auction of a Counterfeit Document Detection System 3