Navigation Links
Tolerx Announces Amendment to Phase 3 DEFEND Protocol
Date:8/11/2009

CAMBRIDGE, Mass., Aug. 11 /PRNewswire/ -- Tolerx, Inc., a biopharmaceutical company engaged in the discovery and development of novel therapies for immune-mediated diseases, today announced changes to the protocol for its Phase 3 clinical trial DEFEND, which is testing the safety and efficacy of otelixizumab, a targeted T cell immunomodulator, in patients with new-onset autoimmune type 1 diabetes.

The DEFEND (Durable Response Therapy Evaluation For Early or New-Onset Type 1 Diabetes) protocol amendment includes two key changes to the study: expansion of the eligible patient age range from 18-35 years to 12-45 years, and the shortening of the infusion time for each administration of otelixizumab from 2 hours to 30 minutes. Both of these enhancements are supported by clinical data derived from Tolerx's ongoing Phase 2 study called TTEDD.

"From a clinical perspective, I believe this amendment significantly improves the protocol for the DEFEND trial," said Peter A. Gottlieb, MD, Associate Professor of Pediatrics and Medicine at the Barbara Davis Center at the University of Colorado at Denver, and a principal investigator in the DEFEND study. "Most notably, through the expansion of the patient age range to include adolescents, Tolerx is widening the options available to physicians interested in providing new investigational treatment options to this important and growing adolescent patient population."

Dr. Douglas J. Ringler, President and Chief Executive Officer of Tolerx, also commented on the news: "We are pleased with this amendment on multiple levels and are hopeful that both the expansion of the target population and the more convenient dosing regimen will further expand the enthusiasm for this trial in the diabetes community. Our commitment to type 1 diabetes patients is evidenced in our efforts to develop a short, conven
'/>"/>

SOURCE Tolerx, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Tolerx Named as One of the Fierce 15 Biotech Companies of 2008
2. Laureate Announces Manufacturing Agreement with Tolerx
3. Tolerx Expands Phase 3 DEFEND Trial of Otelixizumab in Europe
4. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
5. YM BIOSCIENCES ANNOUNCES COMPLIANCE WITH AIM RULE 26
6. Emisphere Technologies, Inc. Announces Pricing of Registered Direct Offering
7. BioLife Solutions Announces Exclusive CryoStor(TM) Supply Agreement With the New England Cryogenic Center, Inc.
8. Carrington Announces Nasdaq Communication; Prepares for Shares to Be Quoted on the OTC Bulletin Board and Pink Sheets
9. China Kangtai Cactus Biotech Files 2nd Quarter 2007 10QSB and Announces Unaudited Quarterly Results
10. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
11. Advanced Life Sciences Announces Receipt of Nasdaq Staff Letter
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/30/2015)... across the globe, ISN improves the efficiency and effectiveness of contractor management systems. ISN,s ... reliable contractors in over 80 countries. ... ... Over 60,000 Worldwide Customers In More Than 80 Countries ... Headquartered in Dallas, TX , ISN has additional offices in Calgary ...
(Date:7/30/2015)... ... 30, 2015 , ... As part of its 2015 growth plan and as a follow up ... business units, Whitehouse Laboratories is pleased to announce that it has begun construction on ... of Excellence and will be strictly dedicated to basic USP 51, USP 61, and USP ...
(Date:7/29/2015)... According to a new market research report, ... , published by Mordor Intelligence, the Global market is expected ... 2020, with North America being the ... global market size. The Global market for Stem Cells is ... period of (2015-2020).      (Logo: http://photos.prnewswire.com/prnh/20150428/740799) , ...
(Date:7/29/2015)... July 29, 2015  HealthSouth Corporation ... largest providers of post-acute healthcare services, offering both ... results of operations for the second quarter ended ... was characterized by strong volume growth in both ... EBITDA," said Jay Grinney, President and Chief Executive ...
Breaking Biology Technology:ISN Reaches Over 60,000 Worldwide Customers 2ISN Reaches Over 60,000 Worldwide Customers 3Whitehouse Labs Formally Announces Plans to Open a Microbiological Laboratory 2Asia Pacific to Dominate the Global Stem Cell Market - Vericel Corporation, Ocata Therpeutics, Athersys Inc., Cryo-Cell International, Geron Corporation, StemCells, Inc. Among the Major Players 2Asia Pacific to Dominate the Global Stem Cell Market - Vericel Corporation, Ocata Therpeutics, Athersys Inc., Cryo-Cell International, Geron Corporation, StemCells, Inc. Among the Major Players 3HealthSouth Reports Results for Second Quarter 2015 2HealthSouth Reports Results for Second Quarter 2015 3HealthSouth Reports Results for Second Quarter 2015 4HealthSouth Reports Results for Second Quarter 2015 5HealthSouth Reports Results for Second Quarter 2015 6HealthSouth Reports Results for Second Quarter 2015 7HealthSouth Reports Results for Second Quarter 2015 8HealthSouth Reports Results for Second Quarter 2015 9HealthSouth Reports Results for Second Quarter 2015 10HealthSouth Reports Results for Second Quarter 2015 11HealthSouth Reports Results for Second Quarter 2015 12HealthSouth Reports Results for Second Quarter 2015 13HealthSouth Reports Results for Second Quarter 2015 14HealthSouth Reports Results for Second Quarter 2015 15HealthSouth Reports Results for Second Quarter 2015 16HealthSouth Reports Results for Second Quarter 2015 17HealthSouth Reports Results for Second Quarter 2015 18HealthSouth Reports Results for Second Quarter 2015 19HealthSouth Reports Results for Second Quarter 2015 20HealthSouth Reports Results for Second Quarter 2015 21HealthSouth Reports Results for Second Quarter 2015 22HealthSouth Reports Results for Second Quarter 2015 23HealthSouth Reports Results for Second Quarter 2015 24HealthSouth Reports Results for Second Quarter 2015 25HealthSouth Reports Results for Second Quarter 2015 26HealthSouth Reports Results for Second Quarter 2015 27HealthSouth Reports Results for Second Quarter 2015 28HealthSouth Reports Results for Second Quarter 2015 29HealthSouth Reports Results for Second Quarter 2015 30HealthSouth Reports Results for Second Quarter 2015 31
... , ... Netech Corporation, innovative leader in the manufacture ... its new Infusion Pump Analyzer, IPA 2000. Utilizing Netech’s patent pending ... pump can be measured faster than ever before. IPA 2000 is ...
... , ... President and CEO Sally Van Doren, PharmD, will present at the 9th DIA Conference for ... Dr. Van Doren will present on the topic of the Integrated Summary of Safety. ... Emeryville, CA (PRWEB) November ...
... , ... Medical Centers Simplify Clinical Workflow Using iSirona Technology , ... Panama City, Fla. (PRWEB) November ... today announced the successful "go-live" of iSirona,s DeviceConX at University Hospitals Geneva Medical ...
Cached Biology Technology:Netech Corporation Announces the Release of IPA 2000 -- Infusion Pump Analyzer for Fast and Accurate Testing of All Infusion Pumps 2BioSoteria CEO to Present at Drug Safety Conference 2iSirona Announces Go-live at University Hospitals in Cleveland 2iSirona Announces Go-live at University Hospitals in Cleveland 3
(Date:7/21/2015)... , July 21, 2015 Passwords have ... seen in the recent U.S. Office of Personnel ... to the infosec conundrum, but developers and end-users ... To address this dilemma, Biometrics-as-a-Service provider HYPR Corp. ... Tokenization SDK for third party integration. ...
(Date:7/9/2015)...  Synaptics Inc. (NASDAQ: SYNA ), a leading developer ... report financial results for the fourth quarter and fiscal ... close of market. The company will host a corresponding ... PT (5:00 p.m. ET), during which management may discuss ... live call, analysts and investors should dial 888-455-2260 (conference ...
(Date:7/8/2015)... 8, 2015 Summary Pancreatic cancer is ... most fatal, with a mortality rate of 10.9 deaths ... pancreatic cancer patients has highlighted a significant need for ... being met by the current market. A highly ... with varying molecule types and mechanisms of action, which ...
Breaking Biology News(10 mins):HYPR Corp. Launches Industry First Biometric Tokenization Platform 2HYPR Corp. Launches Industry First Biometric Tokenization Platform 3HYPR Corp. Launches Industry First Biometric Tokenization Platform 4Synaptics to Report Fourth Quarter, Fiscal Year 2015 Results on July 30 2Frontier Pharma: Pancreatic Cancer - Identifying and Commercializing First-in-Class Innovation 2Frontier Pharma: Pancreatic Cancer - Identifying and Commercializing First-in-Class Innovation 3
... City, February 17, 2010The southern limit of permanently frozen ground, ... was 50 years ago in the James Bay region, according ... Laval. In a recent issue of the scientific journal ... suggest that, if the trend continues, permafrost in the region ...
... available in Spanish . An Agricultural ... and other insects over vast acreage so their movements can ... more affordable. That,s according to recently published research ... Agricultural Research Center in Maricopa, Ariz., and his collaborators at ...
... people alike face critical choices as they reproduce: ... many small, poorly-provisioned ones. Different species make strikingly ... life forms: Darwin,s "endless forms most beautiful. ... Smithsonian Tropical Research Institute argues that these diverse ...
Cached Biology News:Permafrost line recedes 130 km in 50 years 2New assay helps track termites and other insects 2Stress and trade-offs explain life's diversity: New Smithsonian model 2
... peptide microarrays designed for quantitative assays ... and built on the flexible and ... of customer specified sequences can be ... provide assistance with custom sequence design. ...
... are intended for laboratory research use only. ... neutral buffered formalin and embedded in paraffin. ... by certified pathologists. Tissue cores were ... into a new recipient paraffin block, in ...
... adult normal Mega Western Protein Array was ... Mega Western Protein Arrays are manufactured using ... tissue sources. A protein sample from each ... with a Protein molecular weight marker on ...
... System, Professional Package Superior Protein Detection ... The ProXPRESS 2D Proteomic Imaging System is ... both proteomic and general life science research ... the use of all dyes in the ...
Biology Products: