Navigation Links
MacroGenics and Lilly Achieve Targeted Patient Enrollment in PROTEGE, a Global Phase 2/3 Clinical Trial of Teplizumab in Type 1 Diabetes
Date:6/16/2009

Phase 3 PROTEGE ENCORE Clinical Trial Initiated

ROCKVILLE, Md. and INDIANAPOLIS, June 16 /PRNewswire/ -- MacroGenics, Inc. and Eli Lilly and Company (NYSE: LLY) today announced that the PROTEGE trial achieved its targeted patient enrollment. The trial is a pivotal Phase 2/3 clinical study evaluating teplizumab, an investigational compound under development for the treatment of individuals with recent-onset type 1 diabetes.

The PROTEGE trial is a randomized, double-blind, multi-center, multi-national, 4-arm, controlled study designed to evaluate the safety and efficacy of teplizumab in individuals with recent-onset type 1 diabetes, aged 8 to 35, who are within 12 weeks of their diagnosis. More than 530 individuals are enrolled in the study across 14 countries, including the United States. The primary composite endpoint for PROTEGE includes both the patient's total daily insulin usage and his/her HbA1c levels at 12 months. Secondary endpoints are evaluated at 24 months. Longer term safety and efficacy data from patients who complete the PROTEGE trial are being collected in a separate Phase 3 study called the PROTEGE Extension trial.

"The completion of enrollment of the PROTEGE study is an important milestone for MacroGenics and for the type 1 diabetes research community," stated Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We appreciate the dedication of the patients, their caregivers and clinical investigators who helped advance this important late-stage clinical trial."

The companies also announced today that they have initiated the PROTEGE ENCORE trial, another Phase 3 global study of teplizumab in individuals with recent-onset type 1 diabetes, designed to capture patient-reported outcome measures in addition to safety and efficacy data. Information about the PROTEGE and PROTE
'/>"/>

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

Page: 1 2 3 4

Related medicine technology :

1. MacroGenics Begins Global Phase 2/3 Protege Study in Recent-onset Type 1 Diabetes Mellitus
2. Lilly Announces Positive Phase II Data on Investigational Medicine for Patients with Type 2 Diabetes
3. Study Showed Lillys GEMZAR(R) (gemcitabine HCl for injection) Improved Progression-Free Survival in Cervical Cancer Patients
4. Lilly Advances Second Alzheimers Disease Treatment Candidate Into Late-Stage Testing by Launching Two Global Trials
5. Amylin and Lilly Announce Plans to Develop Pen Device for Exenatide Once Weekly
6. Lilly Announces Inconclusive Phase II Study Results for mGlu2/3 at the International Congress on Schizophrenia Research
7. FDA Issues a Complete Response Letter for Lillys Olanzapine LAI for Treatment of Schizophrenia in Adults
8. Lilly Withdraws Application for Additional U.S. Indication for Cymbalta(R) for Chronic Pain
9. Daiichi Sankyo and Lilly Respond to Speculation on Status of Prasugrel New Drug Application
10. Lilly and Deciphera Pharmaceuticals Announce Licensing and Collaboration Agreement
11. Lilly Announces Initiation of Second Global Phase III Trial of Investigational Alzheimers Disease Compound
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... , Jan. 15, 2014  Valeant Pharmaceuticals International, Inc. ... that the applicable waiting period under the Hart-Scott-Rodino Antitrust ... previously announced tender offer by its indirect wholly-owned subsidiary, ... shares of common stock of Solta Medical, Inc. (NASDAQ: ...
(Date:1/15/2014)... , Jan. 15, 2014  A novel wearable injector slightly ... and painless for patients to self-inject prescription drugs in the ... including cancer, blood diseases, autoimmune deficiencies, and genetic disorders.  ... grow to $220B by 2018, according to analysts.   Many of ...
(Date:1/14/2014)... The Brandeis Medical Center, led by Dr. Emmanuel Brandeis , ... laser tattoo removal experience with the advanced Astanza Duality laser and ... quality cosmetic services with cutting edge medical technology and offering expert ... has seen a dramatic increase in the presence of ...
Breaking Medicine Technology:Valeant Pharmaceuticals Announces Receipt Of Antitrust Clearance For Its Previously Announced Acquisition Of Solta Medical, Inc. 2Valeant Pharmaceuticals Announces Receipt Of Antitrust Clearance For Its Previously Announced Acquisition Of Solta Medical, Inc. 3Enable Injections Presents A New Class of Injectors for Drug Delivery at PEPTalk, Drug Delivery Partnership Meetings 2Beverly Hills Physician Features Tattoo Removal with the Astanza Duality Laser, Offers $99 Special 2
... NEW YORK, Jan. 26, 2012 Walgreens, the nation,s largest ... research toward curing, treating, and preventing type 1 diabetes (T1D) ... raise more than $1.4 million in 2011 for JDRF causes. ... JDRF to raise funds for research to put an end ...
... Varian Medical Systems (NYSE: VAR ) today announced ... Therapy Centre LLC to equip a new proton therapy facility ... Varian will equip the new center with a ProBeam™ system ... linear accelerators. Equipment delivery and installation is expected to commence ...
Cached Medicine Technology:Walgreens Raises More Than $1.4 Million in 2011 Campaign to Support Type 1 Diabetes Research 2Walgreens Raises More Than $1.4 Million in 2011 Campaign to Support Type 1 Diabetes Research 3Varian Medical Systems Books $77 Million Order to Equip Proton Treatment Center in Saudi Arabia 2
(Date:4/18/2014)... How did it make you feel? According to psychologists, ... such as how sad you were or how embarrassed ... you can,t stop thinking about it. , When ... of the memories, rather than how you felt, is ... negative effects of these memories, a new study suggests. ...
(Date:4/18/2014)... Diego, Calif. (April 18, 2014) ― A new study ... analyzing weekly patterns in health-related Google searches reveals a ... health strategies. , Investigators from San Diego ... and the Monday Campaigns, analyzed "healthy" Google searches (searches ... e.g., "healthy diet") originating in the U.S. from 2005 ...
(Date:4/17/2014)... of chronic inflammation in benign prostate tissue was ... this association was found even in those with ... study published in Cancer Epidemiology, Biomarkers & ... for Cancer Research. , An analysis of prostate ... placebo arm of the Prostate Cancer Prevention Trial ...
(Date:4/17/2014)... new pain relief targets that could be used ... at King,s College London made the discovery when ... periphery of the body. , Dr Marzia Malcangio ... underlying pain generation and our findings could help ... , One potential side effect of some chemotherapy ...
(Date:4/17/2014)... the April issue of Experimental Biology and ... Drs. Rex Gaskins and Paul Kenis in the ... of the University of Illinois Urbana-Champaign describe their ... reactions underlie a variety of cell functions including ... these crucial roles in regulating normal cellular behavior, ...
Breaking Medicine News(10 mins):Health News:New study suggests a better way to deal with bad memories 2Health News:New study suggests a better way to deal with bad memories 3Health News:New research shows people are thinking about their health early in the week 2Health News:Chronic inflammation may be linked to aggressive prostate cancer 2Health News:Chronic inflammation may be linked to aggressive prostate cancer 3Health News:New pain relief targets discovered 2Health News:Live cell imaging reveals distinct alterations of subcellular glutathione potentials 2
... the devastating earthquake of 8 October 2005 in northern ... risk, facing a second winter without permanent shelter.// ... around 3.5 million homeless. Estimates have shown that even ... recent landslides and flooding have left most quake survivors ...
... Scientist couple, Dr Utpal Bhadra and Monika Pal Bhadra, narrowly ... comparable to the final winners-Andrew Z. Fire and Craig C. ... (Ribonucleic acid interference) in gene silencing got the two American ... the journal Nature in 1998. ,As a matter ...
... people, suspected to be suffering from chikungunya, a viral fever ... Pune.// ,"We have collected blood samples from 10 people ... We also collected blood samples from four people in Ganjam ... Debata, the state's joint director of health told IANS Tuesday. ...
... research by scientists at the Atopy (Allergy) Research Center ... suggests that dust mites and their fecal droppings// disrupt ... to other irritants. ,Episodes of asthma and ... even in previous studies conducted by other researchers. However ...
... one of the greatest challenges facing researchers today, and recent ... a growing epidemic.// The World Health Organization has estimated that ... problems, of them nearly 300 million are obese. ... works on the source of the problem – appetite, the ...
... with breast cancer positive to hormone receptors and HER2 ... (anastrozole) from AstraZeneca to their treatment improves the length ... Phase III clinical trial sponsored by Roche showed that ... after which the cancer continued to progress. ...
Cached Medicine News:Health News:Survivors of Pakistan Earthquake Still at Risk 2Health News:Brain behind the Brawn: Vital Molecule in the Brain Controls Appetite 2
... and highly sought-after, the ... collection of sunglasses and ... the very latest men's ... timeless sources of inspiration ...
... Erbium YAG Extended Ablation laser enables the ... peel with outstanding results and no downtime., The ... fluence level with an extra long pulse width ... Peeling is spread over 3-5 days, and occurs ...
... art software package designed to assist in the ... a lens manufacturer with years of experience in ... designed to help you run your lab the ... software dictates., ,Designed specifically for integrated retail and ...
The new Vascular ClearWay Irrigating PTFE Balloon Catheter is a revolutionary micro-porous PTFE balloon catheter designed for the removal of fresh, soft emboli and thrombi, and for intraluminal irrig...
Medicine Products: