Navigation Links
MacroGenics Begins Global Phase 2/3 Protege Study in Recent-onset Type 1 Diabetes Mellitus

Three Independent Clinical Trials Initiated with Teplizumab Manufactured at


ROCKVILLE, Md., Aug. 2 /PRNewswire/ -- MacroGenics, Inc. announced today that its Protege trial is actively enrolling adults and children ages 8 to 35 with recent-onset type 1 diabetes. The global Phase 2/3 clinical trial will evaluate the safety and efficacy of three teplizumab dosing regimens administered at the start of the study and again at six months in individuals who are up to 12 weeks from their diagnosis of type 1 diabetes. "The initiation of the pivotal Protege study is an important milestone for MacroGenics and for the type 1 diabetes research community," stated Dr. Scott Koenig, President and CEO of MacroGenics. "It is also notable that teplizumab is the first CD3 monoclonal therapy targeting type 1 diabetes to reach this stage of clinical development."

Specifically, the Protege study will assess the ability of teplizumab to inhibit the autoimmune attack that destroys insulin-producing pancreatic beta cells in individuals with type 1 diabetes. If teplizumab is effective and has the ability to preserve or protect beta cells of the pancreas, patients may require less injected insulin and their blood glucose levels may be easier to control. Other research has shown that greater control of blood glucose levels can lead to better long-term health outcomes for patients with type 1 diabetes.

Dr. Koenig also commented, "We are pleased to announce that Dr. Kevan Herold of Yale University and Dr. Bernhard Hering of the University of Minnesota are leading additional teplizumab studies in type 1 diabetes." The AbATE and Delay studies, led by Dr. Herold, are evaluating the safety and efficacy of teplizumab in patients who have had the disease for up to one year. Dr. Hering is evaluating the use of teplizumab as an induction therapy in pancreatic islet cell transplantation.

Additional information regarding the studies is listed in the table below.

Teplizumab Clinical Trials

Study Brief Description Additional Information

Protege trial Global Phase 2/3 trial

for patients with

recent-onset type 1 (search for Protege)

diabetes mellitus (less

than or equal to 12

weeks from symptoms)

ages 8-35 with treatment

at the start of the

study and again at

six months

AbATE trial Led by Dr. Kevan Herold

of Yale University,

this Phase 2 trial, (search for NCT00129259)

funded by the Immune

Tolerance Network and

NIAID, will evaluate

patients with recent-

onset type 1 diabetes

mellitus (less than

or equal to 6 weeks

from diagnosis) ages

8-30 with treatment at

the start of the study

and again at one year

Delay Study Led by Dr. Kevan Herold

of Yale University, (search for NCT00378508)

this Phase 2 trial funded

by NIDDK is for patients

ages 8-30 with type 1

diabetes mellitus within

4-12 months of diagnosis

Pancreatic Led by Dr. Bernhard

islet cell Hering of the University (search for NCT00265473)

transplantation of Minnesota, this Phase

with teplizumab 2 trial funded by NIDDK

induction is enrolling patients

therapy less than 40 years old

who have been insulin

dependent for more

than 5 years

About Teplizumab

Teplizumab, also called MGA031 and hOKT3-gamma-1 (Ala-Ala), is a humanized monoclonal antibody engineered to alter the function of the T lymphocytes that mediate the destruction of the insulin-producing beta cells of the islets of the pancreas. Teplizumab binds to an epitope of the CD3-epsilon chain expressed on mature T cells and by doing so, may modulate the immunologic response that causes disease.

About Type 1 Diabetes

Type 1 diabetes is an autoimmune disease in which the body's immune system attacks and destroys the insulin-producing beta cells of the pancreas. The symptoms associated with type 1 diabetes can appear suddenly and leave a person dependent on injected insulin for life. The disease carries the constant threat of devastating complications such as heart and kidney disease, nerve damage and blindness. Although diagnosis most often occurs in childhood and adolescence, the disease can strike adults as well. Individuals with type 1 diabetes must test their blood sugar four or more times per day and take multiple insulin injections daily or continually infuse insulin through a pump. While trying to balance insulin doses with their food intake and daily activities, people with this form of diabetes must always be prepared for serious hypoglycemic (low blood sugar) and hyperglycemic (high blood sugar) reactions, both of which impact quality of life and can be life threatening. This balance is especially difficult to achieve in children and young adults who are very active physically.

About MacroGenics, Inc.

Founded in 2000, MacroGenics is a private, venture-backed biotechnology company headquartered in Rockville, Maryland that focuses on the development, manufacture, and commercialization of immunotherapeutics for autoimmune disorders, cancer and infectious diseases. The company's proprietary Fc engineering technology offers ways of improving antibody function, such as enhancing the antibody's ability to eliminate cancer cells, cells that contribute to autoimmune disorders, or those infected with certain pathogens. The company is developing first-in-class product candidates from its autoimmunity, oncology and infectious disease portfolios. For more information about MacroGenics, please visit

Statements made in this news release that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "expects," "believes," "intends," and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those projected in any forward- looking statement. Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as the Company's ability to raise additional capital, and risks related to the Company's ability to initiate, and enroll patients in, planned clinical trials. You should not place undue reliance on any forward-looking statements. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by law.

SOURCE MacroGenics, Inc.

Copyright©2007 PR Newswire.

Related medicine technology :

1. The International Myeloma Foundation Says Data Reported at a Global Medical Meeting in Greece Demonstrates Improved Survival for a Wide Range of Myeloma Patients
2. New Report Looking at Chiral Technologies Analyzes the Global Market Growth Forecasts Driven By Two Very Important Components as Single Isomer Drugs and Single Enantiomer Pharmaceuticals
3. New Study Reveals Limitations of a Complex and Challenging Global Tuberculosis Drug Marketplace
4. Global Rabies Treatment May be Possible with NanoViricides Drugs
5. Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer
6. Phase 3 Results for Dabigatran Etexilate, an Investigational Oral Anticoagulant, Presented Today at the XXIst Congress of the International Society on Thrombosis and Haemostasis
7. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
8. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
9. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
10. Actemra (tocilizumab) Third Phase III Study Results Show Significant Improvement in Symptoms of Patients with Rheumatoid Arthritis
11. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
Post Your Comments:
(Date:11/29/2015)... , Nov. 29, 2015   Royal Philips  ... driven radiology solutions at the 2015 Radiological Society of ... 4 at McCormick Place in Chicago ... will experience the company,s broad portfolio of integrated Diagnostic ... solutions to increase clinical performance, improve workflow and create ...
(Date:11/29/2015)... CIVCO Medical Solutions will demonstrate the ... Society of North America ... November 29 – December 4, 2015. The Verza ... unrivaled versatility, enhanced user experience and deliver confident ... --> --> ...
(Date:11/27/2015)... November 27, 2015 --> ... to go online. The potential to save costs, improve ... and far from fully exploited as yet. Here, particular ... records, either via mobile tablet or directly at the ... ) -->      (Photo: ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... November 27, 2015 , ... ... through sharing, the 2016 Building Better Radiology Marketing Programs meeting will ... on Sunday, March 6, 2016, at Caesars Palace in Las Vegas with a ...
(Date:11/27/2015)... ... November 27, 2015 , ... A simply groundbreaking television series, "Voices in America", ... delves into an array of issues that are presently affecting Americans. Dedicated to providing ... this show is changing the subjects consumers focus on, one episode at a time. ...
(Date:11/27/2015)... ... November 27, 2015 , ... ... innovative online platform for mental health and wellness consultation, has collaborated with a ... will bridge the knowledge gap experienced by parents and bring advice from parenting ...
(Date:11/27/2015)... Chicago, IL (PRWEB) , ... November 27, 2015 ... ... some of the largest, most successful and prominent nonprofit healthcare organizations in the ... and governance involvement with various organizations, and helped advance the healthcare industry as ...
(Date:11/27/2015)... ... November 27, 2015 , ... Avid collector, Andrew Hawley from Vintage ... style concert posters. This is one of Joplin's most famous and beautiful concert posters. ... University of Michigan in Ann Arbor. The According to Hawley, "It is hard to ...
Breaking Medicine News(10 mins):