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

0

GOOD

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:5/17/2013)... Topricin Pain Relief and Healing Cream, ... among nationally recommended over-the-counter (OTC) health products 2012 ... News" Health in collaboration with "Pharmacy Times." ... Pharmacists Recommended designation” in the “Topical Analgesics” category, ... is the only homeopathic formula to earn that ...
(Date:5/17/2013)... 17, 2013 Dr. Sparano is Professor ... Health at the Albert Einstein College of Medicine and ... Montefiore Medical Center. He is also Associate Director ... leads the Einstein Breast Cancer Working Group, a multidisciplinary ... cancer research. He also serves as Vice Chair of ...
(Date:5/17/2013)... (PRWEB) May 17, 2013 Oven Industries ... capabilities. The 5R6-900 temperature controller has many user-friendly benefits. ... plugged into the wall as a self-contained temperature ... This distinctive detail makes the device unique, as well ... controller can also be used universally, which allows the ...
(Date:5/17/2013)... recipient,s immune system identifies the transplanted organ as foreign ... T cells, the immune cells that mediate rejection, must ... order to migrate to the transplanted organ. In this ... Fadi Lakkis and colleagues at the University of Pittsburgh ... cells is not required for migration. Instead, these cells ...
Breaking Biology Technology:Pharmacists' Picks: Topical BioMedics' Topricin Listed on Top Recommended OTC Health Products 2Joseph A. Sparano, MD, Named Vice Chair of ECOG-ACRIN Cancer Research Group 2Joseph A. Sparano, MD, Named Vice Chair of ECOG-ACRIN Cancer Research Group 3New Temperature Control Products Announced by Oven Industries Inc. 2
... Alexion,Pharmaceuticals, Inc. (Nasdaq: ALXN ) today announced ... Officer of Alexion,Pharmaceuticals, will present at the William ... 9:10 a.m., local time (10:10 a.m., eastern) on,Thursday, ... Mr. Sinha,s remarks will be available live. You ...
... Beckman,Coulter, Inc. (NYSE: BEC ), a leading ... and innovate complex biomedical tests,announces upcoming company presentations ... (Logo: http://www.newscom.com/cgi-bin/prnh/20031202/BECLOGO ), ... July 25, 2008., -- July 28 - ...
... Universities of Cambridge and Bristol have revealed that the ... the vacuum of a mass spectrometer. Their research ... Express . , The researchers were surprised to discover ... always been assumed that they would not survive once ...
Cached Biology Technology:Upcoming Beckman Coulter Investor Events Second Half of 2008 2Membrane complexes take flight 2
(Date:5/18/2013)... 18, 2013) Research presented today at Digestive Disease ... with findings about the impact of coffee on autoimmune ... While coffee consumption recently has been associated with reduced ... a few more cups of java each month also ... disease. Researchers at the Mayo Clinic, Rochester, MN, linked ...
(Date:5/18/2013)... 2013) Research presented at Digestive Disease Week ... through diet and lifestyle. , Individuals suffering ... muscle strength, fatigue and poor quality of life. ... in remission. A randomized, double blind, placebo-controlled study ... supplementation corresponded to significant relief of these symptoms. ...
(Date:5/18/2013)... 18, 2013) An increasing number of U.S. ... to resolve, according to research presented at Digestive ... targeting obesity, researchers at the Cleveland Clinic Children,s ... pattern of exhaled breath compared to their lean ... compound levels that can be correlated to potential ...
Breaking Biology News(10 mins):Coffee consumption associated with reduced risk of autoimmune liver disease 2Research examines new methods for managing digestive health 2Research examines new methods for managing digestive health 3New research identifies risks, interventions for children's GI health 2New research identifies risks, interventions for children's GI health 3
... A global collaborative has produced a first draft ... that will lead to insights in agriculture, medicine, conservation ... farm at the University of Illinois will now be ... had their genomes sequenced. Researchers will announce the achievement ...
... / - PDC Biotech GmbH (PDC) today announced the ... Verwaltungs AG (Munich) and Edmond de Rothschild Investment Partners (Paris) co-led ... used to complete preclinical work and the first clinical study of ... for the treatment of preterm labour and primary dysmenorrhea . ...
... 2009) -- A husband and wife team of American paleontologists has ... ago during the early Cretaceous of central Montana. The new ... of the Canadian Journal of Earth Sciences . Ankylosaurs are ... a plate-like armour with two sets of sharp spikes on each ...
Cached Biology News:First draft of the pig: Researchers sequence swine genome 2First draft of the pig: Researchers sequence swine genome 3PDC Biotech GmbH Announces Close of Series A Financing 2PDC Biotech GmbH Announces Close of Series A Financing 3New dinosaur species from Montana 2
TXNL2 Antibody...
Goat polyclonal to Glucose Dehydrogenase ( Abpromise for all tested applications). Antigen: Glucose Dehydrogenase (Bacillus species)...
Goat polyclonal to HNF4 ( Abpromise for all tested applications). Antigen: Synthetic peptide: RLSKTLVDMDMADY (Human) N terminal. Entrez GeneID: 3172 Swiss Protein ID: P41235...
ATGL Antibody Shipping Temperature: HOT Storage Temperature: -20C...
Biology Products: