[Previous Months][Date Index][Thread Index][Join - Register][Login]
  [Message Prev][Message Next][Thread Prev][Thread Next]

[IP] Fwd: JDRF Research E-Newsletter #20



In a message dated 5/30/02 2:46:18 PM Pacific Daylight Time, email @ redacted
writes:


> JDRF RESEARCH E-NEWSLETTER #20
> May 30, 2002
>
>
> The Juvenile Diabetes Research Foundationbs Research E-Newsletter provides
> all those interested with the latest information about research on type 1
> diabetes and its complications.  Please forward this report to others who
> may be interested.  To add your name to the distribution list, send an
> e-mail to email @ redacted <mailto:email @ redacted> with bSubscribe to Research
> E-Newsletterb in the subject line and your full name and postal address in
> the message portion of the e-mail.  If you do not wish to receive future
> mailings of this newsletter, please send an e-mail to email @ redacted <
> mailto:email @ redacted> with bUnsubscribe to Research E-Newsletterb in the
> subject line.
>
>
> REPORT ON THE NEW ENGLAND JOURNAL OF MEDICINE STUDY,
> bAnti-CD3 Monoclonal Antibody in New-Onset Type 1 Diabetes Mellitusb
>
> As reported in the May 30 issue of The New England Journal of Medicine and
> widely in the media today, JDRF-funded researchers Kevan Herold, M.D., at
> Columbia University, and Jeffrey Bluestone, Ph.D., director of the JDRF
> Center for Islet Transplantation at the University of California, San
> Francisco/University of Minnesota, arrested early stage type 1 diabetes for
> a year in nine out of 12 patients by treating them for two weeks with an
> immune-suppressing drug.
>
> The JDRF co-sponsored Phase I/II human clinical trial, bTreatment of new
> onset type 1 diabetes with hOKT3g1(Ala-Ala)b began enrollment in the
spring
> of 1999. A random clinical trial measuring the drugbs safety,
tolerability,
> and effectiveness was conducted to determine whether the drug could
> preserve insulin production for a year or longer.  Todaybs published study
> covers results after following the patientsb progress for one year.
>
> The drug:  OKT3, a modified bhumanizedb form of an antibody known as
> anti-CD3, works as an immunosuppressant, by blocking the function of a
> specific set of T cells that orchestrate the destruction of islets.  It
> prevents activation of the T cells after they have identified their target,
> disarming them once they are poised to attack.
>
> The protocol and results: For two weeks, 12 patients, ages 7 to 30, all
> newly diagnosed with type 1 (within 8 weeks of diagnosis), and all
> receiving insulin therapy, received daily injections of hOKT3g1(Ala-Ala).
> Another 12 patients received nothing to serve as a control group. The
> patients were then followed for a year (and beyond) to observe the effects.
> Nine of 12 in the treated group (75 percent) maintained or improved insulin
> production (marked by a significant decrease in the need for injected
> insulin), while 10 of the 12 controls had a significant decrease. The
> treated patients also showed improvements in other clinical signs and
> symptoms of diabetes, including improvement in metabolic control and better
> hemoglobin A1c levels. (The report also includes positive data for most of
> the subjects in the first months of the second year after treatment.)
>
> Results indicated that the drug is safe. Because it is so targeted and
> selective, the drug fulfilled its goal of preserving islets and beta cell
> function without causing serious side effects or suppressing the entire
> immune system. In doing so, it avoided some of the serious drawbacks of
> other protocols in the past.
>
> Future trials: Further testing of the new therapy, expanding parameters of
> the current study, is planned in a multi-center clinical trial of more than
> 80 patients to be conducted by the Immune Tolerance Network (ITN), a
> seven-year, $144 million project co-funded by JDRF, NIDDK and NIAID. JDRF
> is also currently funding a similar human clinical trial at the JDRF Center
> for Beta Cell Therapy in Europe, using another anti-CD3 drug in the effort
> to protect natural beta cells in patients with recent-onset type 1
> diabetes.  Several JDRF Centers, including those focused on gene therapy,
> are researching ways to transfer protective genes to beta cells so they can
> continue to function.
>
> The focus on intervention in patients with newly diagnosed type 1 diabetes
b
>  at a point where sustaining the ability to secrete insulin rather than
> depending completely on insulin injections b has important clinical
> benefits.  According to leading diabetes researcher Edwin A.M. Gale, M.D.,
> in an editorial in The New England Journal of Medicine accompanying the
> study, there is a bvirtuous circle,b by which bresidual insulin
secretion
> resulted in better glucose control with less hypoglycemia and slower
> progression to vascular complications.  Better glucose control, in turn,
> prolonged beta-function.b
>
> Prevention: While the goal of this trial was to preserve existing beta cell
> mass and function and prevent further beta cell destruction in the newly
> diagnosed b all falling under Goal Area #1: Restoration of normal blood
> sugar levels b the trial also represents a significant breakthrough in
> efforts to prevent the disease from occurring (Goal Area 3: Prevention of
> diabetes and its recurrence.)
>
> The gradual autoimmune process that leads to type 1 diabetes begins long
> before the disease is diagnosed and usually continues after diagnosis until
> all the pancreatic islets are destroyed. The hope, then, is to eventually
> test this protocol and attempt interventions with people found to be at
> high risk for the disease before diagnosis (as well as with people who have
> been diagnosed for six months or longer.)
>
> JDRFbs Commitment: JDRF continues to commit about two-thirds of its
overall
> investment in Goal Area l, with strong emphasis on islet transplantation.
> But within its commitments for Goal Area 3 b accounting for about 15% of
> total funding b we are pursuing initiatives b among them, several major
> JDRF international partnerships b for which the present study has
important
> implications.  Among them: the Diabetes Prediction and Prevention (DIPP)
> study, screening about 20% of all Finnish babies to determine their risk
> for developing diabetes (funded through the JDRF Center for Prevention of
> Type 1 Diabetes in Finland); the JDRF/Wellcome Trust Diabetes and
> Inflammation Lab at the University of Cambridge, performing landmark
> genetic studies; the JDRF/NIDDK international Type 1 Diabetes Consortium b
> bringing together critical data from around the world; and the Diabetes
> Vaccine Development Center (in collaboration with the Australian National
> Health and Medical Research Council). JDRF is also a co-funder of the
> Diabetes Prevention Trials-Type 1 (DPT-1), one of which, the Oral Insulin
> Trial, is still recruiting patients. (SEE BELOW)
>
> To read the study and editorial in The New England Journal of Medicine,
> click below (fee required):
> http://content.nejm.org
>
> To read an article on the studybs success reported in the May 30 New York
> Times, click below:
> http://www.nytimes.com/2002/05/30/health/30DIAB.html
>
> To read JDRFbs Web feature story on the Herold/Bluestone study, click
> below:
> http://www.jdf.org/research/homepage.php
>
> To read the University of California at San Francisco press release on the
> study, click below:
> http://pub.ucsf.edu/today/cache/news/200205292.html
>
> To read about the currently-enrolling DPT-1 oral insulin preventive trial,
> click below:
> http://www.jdf.org/research/feature/res052902a.php
>
> To read more about predicting and preventing type 1 diabetes, click below:
> http://www.jdf.org/research/feature/res050102.php
>
>
>     To unsubscribe, please click:
> http://jdrf.globalcloud.net/index.cfm?fuseaction=Home.Unsubscribe&
> email=email @ redacted
Return-Path: <email @ redacted>
Received: from  rly-xh01.mx.aol.com (rly-xh01.mail.aol.com
  [172.20.115.230]) by air-xh02.mail.aol.com (v86.11) with ESMTP id
  MAILINXH23-0530174618; Thu, 30 May 2002 17:46:18 -0400
Received: from  dcbackup.gcnet.globalcloud.net ([64.154.105.7]) by
  rly-xh01.mx.aol.com (v86.11) with ESMTP id MAILRELAYINXH13-0530174556;
  Thu, 30 May 2002 17:45:56 -0400
Received: from dcbackup.gcnet.globalcloud.net ([64.154.105.9] RDNS
  failed) by dcbackup.gcnet.globalcloud.net with Microsoft
  SMTPSVC(5.0.2195.2966); Thu, 30 May 2002 17:45:16 -0400
Content-type: text/plain
Date: Thu, 30 May 2002 16:50:28 -0400
From: email @ redacted
Subject: JDRF Research E-Newsletter #20
To: email @ redacted
Message-ID: <email @ redacted>
X-OriginalArrivalTime: 30 May 2002 21:45:16.0025 (UTC)
  FILETIME=[48EE4E90:01C20823]
X-Mailer: Unknown (No Version)

JDRF RESEARCH E-NEWSLETTER #20
May 30, 2002


The Juvenile Diabetes Research Foundations Research E-Newsletter provides all those interested with the latest information about research on type 1 diabetes and its complications.  Please forward this report to others who may be interested.  To add your name to the distribution list, send an e-mail to email @ redacted <mailto:email @ redacted> with Subscribe to Research E-Newsletter in the subject line and your full name and postal address in the message portion of the e-mail.  If you do not wish to receive future mailings of this newsletter, please send an e-mail to email @ redacted <mailto:email @ redacted> with Unsubscribe to Research E-Newsletter in the subject line.


REPORT ON THE NEW ENGLAND JOURNAL OF MEDICINE STUDY,
Anti-CD3 Monoclonal Antibody in New-Onset Type 1 Diabetes Mellitus

As reported in the May 30 issue of The New England Journal of Medicine and widely in the media today, JDRF-funded researchers Kevan Herold, M.D., at Columbia University, and Jeffrey Bluestone, Ph.D., director of the JDRF Center for Islet Transplantation at the University of California, San Francisco/University of Minnesota, arrested early stage type 1 diabetes for a year in nine out of 12 patients by treating them for two weeks with an immune-suppressing drug.

The JDRF co-sponsored Phase I/II human clinical trial, Treatment of new onset type 1 diabetes with hOKT3g1(Ala-Ala) began enrollment in the spring of 1999. A random clinical trial measuring the drugs safety, tolerability, and effectiveness was conducted to determine whether the drug could preserve insulin production for a year or longer.  Todays published study covers results after following the patients progress for one year.  

The drug:  OKT3, a modified humanized form of an antibody known as anti-CD3, works as an immunosuppressant, by blocking the function of a specific set of T cells that orchestrate the destruction of islets.  It prevents activation of the T cells after they have identified their target, disarming them once they are poised to attack.  

The protocol and results: For two weeks, 12 patients, ages 7 to 30, all newly diagnosed with type 1 (within 8 weeks of diagnosis), and all receiving insulin therapy, received daily injections of hOKT3g1(Ala-Ala). Another 12 patients received nothing to serve as a control group. The patients were then followed for a year (and beyond) to observe the effects. Nine of 12 in the treated group (75 percent) maintained or improved insulin production (marked by a significant decrease in the need for injected insulin), while 10 of the 12 controls had a significant decrease. The treated patients also showed improvements in other clinical signs and symptoms of diabetes, including improvement in metabolic control and better hemoglobin A1c levels. (The report also includes positive data for most of the subjects in the first months of the second year after treatment.)

Results indicated that the drug is safe. Because it is so targeted and selective, the drug fulfilled its goal of preserving islets and beta cell function without causing serious side effects or suppressing the entire immune system. In doing so, it avoided some of the serious drawbacks of other protocols in the past. 

Future trials: Further testing of the new therapy, expanding parameters of the current study, is planned in a multi-center clinical trial of more than 80 patients to be conducted by the Immune Tolerance Network (ITN), a seven-year, $144 million project co-funded by JDRF, NIDDK and NIAID. JDRF is also currently funding a similar human clinical trial at the JDRF Center for Beta Cell Therapy in Europe, using another anti-CD3 drug in the effort to protect natural beta cells in patients with recent-onset type 1 diabetes.  Several JDRF Centers, including those focused on gene therapy, are researching ways to transfer protective genes to beta cells so they can continue to function.
 
The focus on intervention in patients with newly diagnosed type 1 diabetes  at a point where sustaining the ability to secrete insulin rather than depending completely on insulin injections  has important clinical benefits.  According to leading diabetes researcher Edwin A.M. Gale, M.D., in an editorial in The New England Journal of Medicine accompanying the study, there is a virtuous circle, by which residual insulin secretion resulted in better glucose control with less hypoglycemia and slower progression to vascular complications.  Better glucose control, in turn, prolonged beta-function.

Prevention: While the goal of this trial was to preserve existing beta cell mass and function and prevent further beta cell destruction in the newly diagnosed  all falling under Goal Area #1: Restoration of normal blood sugar levels  the trial also represents a significant breakthrough in efforts to prevent the disease from occurring (Goal Area 3: Prevention of diabetes and its recurrence.)

The gradual autoimmune process that leads to type 1 diabetes begins long before the disease is diagnosed and usually continues after diagnosis until all the pancreatic islets are destroyed. The hope, then, is to eventually test this protocol and attempt interventions with people found to be at high risk for the disease before diagnosis (as well as with people who have been diagnosed for six months or longer.)  

JDRFs Commitment: JDRF continues to commit about two-thirds of its overall investment in Goal Area l, with strong emphasis on islet transplantation.  But within its commitments for Goal Area 3  accounting for about 15% of total funding  we are pursuing initiatives  among them, several major JDRF international partnerships  for which the present study has important implications.  Among them: the Diabetes Prediction and Prevention (DIPP) study, screening about 20% of all Finnish babies to determine their risk for developing diabetes (funded through the JDRF Center for Prevention of Type 1 Diabetes in Finland); the JDRF/Wellcome Trust Diabetes and Inflammation Lab at the University of Cambridge, performing landmark genetic studies; the JDRF/NIDDK international Type 1 Diabetes Consortium  bringing together critical data from around the world; and the Diabetes Vaccine Development Center (in collaboration with the Australian National Health and Medical Research Council). JDR!
F is also a co-funder of the Diabetes Prevention Trials-Type 1 (DPT-1), one of which, the Oral Insulin Trial, is still recruiting patients. (SEE BELOW) 

To read the study and editorial in The New England Journal of Medicine, click below (fee required):
http://content.nejm.org  

To read an article on the studys success reported in the May 30 New York Times, click below:
http://www.nytimes.com/2002/05/30/health/30DIAB.html  

To read JDRFs Web feature story on the Herold/Bluestone study, click below:
http://www.jdf.org/research/homepage.php  

To read the University of California at San Francisco press release on the study, click below:
http://pub.ucsf.edu/today/cache/news/200205292.html  

To read about the currently-enrolling DPT-1 oral insulin preventive trial,
click below:
http://www.jdf.org/research/feature/res052902a.php  

To read more about predicting and preventing type 1 diabetes, click below:
http://www.jdf.org/research/feature/res050102.php  

            
    To unsubscribe, please click: http://jdrf.globalcloud.net/index.cfm?fuseaction=Home.Unsubscribe&email=email @ redacted
----------------------------------------------------------
for HELP or to subscribe/unsubscribe, contact: HELP@insulin-pumpers.org
send a DONATION http://www.Insulin-Pumpers.org/donate.shtml