Navigation Links
Tolerx Advancing Novel Type 1 Diabetes Agent into Phase III Clinical Trial Program Following End of Phase II FDA Meeting
Date:4/9/2008

Phase III study will evaluate effects of otelixizumab, an investigational

anti-CD3 monoclonal antibody, on preservation of endogenous insulin

secretion

CAMBRIDGE, Mass., April 9, 2008 /PRNewswire/ - Tolerx, Inc., a biopharmaceutical company engaged in the discovery and development of novel therapies for immune-mediated diseases, today announced that it is proceeding toward the initiation of a Phase III study of otelixizumab in new-onset type 1 diabetes. Tolerx is initiating this pivotal trial after reviewing the results of the otelixizumab development program with the US Food and Drug Administration (FDA) at an End of Phase II meeting.

The Phase III study, known as DEFEND (Durable Response Therapy Evaluation For Early or New Onset Type 1 Diabetes), will be conducted at multiple centers in North America and Europe and will evaluate whether a single course of otelixizumab reduces the amount of administered insulin required for control of blood glucose levels by inhibiting destruction of beta cells. Maintenance of beta cell function has been associated with improved glycemic control (HbA1c levels), fewer hypoglycemic events and reduction of long term disease complications in established diabetics in the Diabetes Control and Complications Trial (DCCT). DEFEND enrollment is expected to begin mid-2008.

"We are very pleased with the outcome of the End of Phase II meeting with FDA and the opportunity to advance initiation of the DEFEND trial. This step is a significant and important milestone for Tolerx," said Dr. Douglas J. Ringler, President and Chief Executive Officer of Tolerx. "The rigorous science behind our Phase II clinical program has provided us with valuable insights that facilitated our moving forward into DEFEND with an optimized dosing regimen that has the potential to transform the treatment paradigm for type 1 diabetes."

"We have worked closely with FDA over several years to ensure that
'/>"/>

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

Page: 1 2 3 4

Related medicine technology :

1. Tolerx Achieves Milestone with Completion of Phase Ib Clinical Study of TRX1 in Cutaneous Lupus Erythematosus
2. Novel Technology Breaks Through Cancer Pain
3. Iomai Trial Shows 100 Percent Immune Response in Elderly Subjects Vaccinated With Novel Travelers Diarrhea Patch Vaccine
4. Pharmacopeia Assists the World Health Organization in the Discovery of Novel Therapeutics for the Treatment of Malaria
5. Quark Pharmaceuticals Files Patent Application Covering Novel Chemical Modifications to its RNAi Molecules
6. Ardea Biosciences, Inc. Announces Completion of Phase 1 Clinical Trials of Novel Investigational HIV Drug RDEA806
7. The Lancet Publishes Major Phase 3 Study on Novel Oral Direct Thrombin Inhibitor
8. Study Results for Aclidinium Bromide, a Novel Anticholinergic, Presented at European Respiratory Society Annual Congress
9. Phase 2 Clinical Studies Initiated for a Novel Therapeutic Candidate Identified Through Pharmacopeia Collaboration
10. Oncology Drugs Development Update - Worldwide Markets and Forecasts of Approved EGFr/HEr2 Inhibitors, Treatment Costs, Pathway Analysis, Current and Expanded Clinical Indications, and Novel Agents in Development
11. ECLIPSE Data on Effects of Otsukas Investigational Novel Treatment, Tolvaptan, on Advanced Heart Failure Patients Hemodynamics and Urine Output Featured in Heart Failure Society of Americas Late Breaking Trials
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... Ky. , Jan. 15, 2014  Manufacturers, suppliers ... must be able to protect their most important ... http://photos.prnewswire.com/prnh/20130716/CL46586LOGO ) Because of ... it steadfastly remains one of the most litigious ...
(Date:1/15/2014)... 2014 MultiCell Technologies, Inc. (OTC Bulletin Board: ... application concerning composition of matter, biological targets, mechanism of ... death.  This patent application describes a ... molecules (VSRNAs) which interfere with the basic homeostatic cellular ...
(Date:1/15/2014)... Jan. 15, 2014  According to Millennium Research Group ... intelligence, the United States ... markets will expand moderately through 2022, with embolization ... particular, increasing interest in drug-eluting beads (DEBs) and ...
Breaking Medicine Technology:Intellectual Property Insurance for Medical-related Products and Services 2MultiCell Technologies Files Patent Application Covering New Class of RNA Therapeutics 2MultiCell Technologies Files Patent Application Covering New Class of RNA Therapeutics 3US and European Transcatheter Embolization and Occlusion Device Market to Surpass $1.6 Billion by 2022 2US and European Transcatheter Embolization and Occlusion Device Market to Surpass $1.6 Billion by 2022 3
(Date:7/9/2014)... MA -- Vasectomy was associated with a small increased ... advanced or lethal prostate cancer according to a new ... researchers found that the association remained even among men ... of lethal cancer cannot be explained by diagnostic bias. ... date to look at the link between vasectomy and ...
(Date:7/9/2014)... Susan Wakulich was told she had an aneurysm, she figured ... her. , "I was devastated," said Wakulich, who is 56 ... this was a serious diagnosis. Then I met Dr. Bernard ... a less invasive procedure. It was something I didn,t even ... a multi-center U.S. clinical trial to evaluate the safety and ...
(Date:7/9/2014)... that captures heretofore hidden ways that cells are regulated, ... makes breast cancer cells more likely to metastasize. , ... in part by blocking two other proteins that are ... two disease processes could have unexpected ties. , ... of Nature , points to the possibility of ...
(Date:7/9/2014)... into the metabolism of stromal support cells and immune ... these cell types in the development of diseases ... and cancer. That was the conclusion of a review ... the leading journal Nature . , Prof. Peter ... call. The metabolism of cancer cells has been examined ...
(Date:7/9/2014)... that fecal transplantation is effective and safe for treating ... the result of a study led by Colleen Kelly, ... Medicine at The Women,s Medicine Collaborative. The study and ... print in the American Journal of Gastroenterology . ... , has increased to epidemic proportions over the past ...
Breaking Medicine News(10 mins):Health News:Vasectomy may increase risk of aggressive prostate cancer 2Health News:New type of stent could help some brain aneurysm patients 2Health News:Protein pushes breast cancer cells to metastasize 2Health News:Protein pushes breast cancer cells to metastasize 3Health News:Wake-up call for more research into cell metabolism 2Health News:Women's Medicine Collaborative examines safety of fecal transplant to treat C. difficile 2
... effective, long-term treatment for trigeminal neuralgia: a painful condition ... sclerosis (MS). Radiation is noninvasive and has less negative ... follow-up in a study of its kind presented October ... American Society for Radiation Oncology (ASTRO). Multiple ...
... HealthDay Reporter , MONDAY, Oct. 25 (HealthDay News) -- ... infants will start sleeping through the night between 2 and ... longer, however, is for the baby,s eight hours of slumber ... study. "The most rapid changes in infant sleep were ...
... cancer drug could be produced cheaply and sustainably using stem ... isolated and grown stem cells from a yew tree whose ... The development could enable the compound to be produced on ... Scientists and engineers behind the development say the ...
... reason many smokers struggle to quit. According to new ... history of anxiety disorders are less likely to quit ... Center for Tobacco Research and Intervention (UW-CTRI), offered free ... , While overall quit rates for the study were ...
... By Kathleen Doheny HealthDay Reporter , MONDAY, Oct. ... with more than half of the segments in the heart,s main ... a new study shows. The good news? Other parts ... within three months or fewer after the run, the researchers found. ...
... HealthDay Reporter , SUNDAY, Oct. 24 (HealthDay News) -- Concussions ... Just last week, the National Football League announced it would ... result in head injuries. Now, a new 12-year study ... been sidelined significantly longer after concussions than they were in ...
Cached Medicine News:Health News:Radiation therapy improves painful condition associated with multiple sclerosis 2Health News:Most Babies Start Sleeping Through Night at 2 to 4 Months 2Health News:Most Babies Start Sleeping Through Night at 2 to 4 Months 3Health News:Plant stem cells could be fruitful source of low-cost cancer drug 2Health News:Common anxiety disorders make it tougher to quit cigarettes 2Health News:Marathons Affect Heart, but Runners Bounce Back 2Health News:Marathons Affect Heart, but Runners Bounce Back 3Health News:NFL Players With Concussions Sidelined Longer: Study 2Health News:NFL Players With Concussions Sidelined Longer: Study 3
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: