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News Bulletin on Lupus Drugs on Development

Epratuzumab shows positive effects in people with lupus in Stage IIb trial

Yesterday, two biopharmaceutical companies, UCB and Immunomedics, announced promising results of their phase IIb study for epratuzumab, their drug in development for treating systemic lupus erythematosus (SLE, or lupus). This is hopeful news for all those affected by this autoimmune disease.

Epratuzumab, developed by Immunomedics and licensed to UCB in 2006 for possible treatment of all autoimmune dieases, is a humanized anti-CD22 monoclonal antibody with the potential to modulate B Cell activity. Although the exact role of CD22 in autoimmunity is not fully understood, it is considered to be a negative regulator of B cell function. B cells are known to contribute to lupus by producing antibodies against the body's own cells and tissues, causing the immune system to turn on itself and resulting in the inflammation and tissue damage that are the hallmarks of lupus. UCB and Immunomedic's released trial results showed that the treatment advantage of epratuzumab over a placebo reached 24.9% at week 12.

WHAT THIS MEANS FOR PEOPLE WITH LUPUS: 

UCB will better understand how to design a potential phase III trial studying many more patients. The results of the phase IIb study will help give UCB researchers confidence in determining best dosage and frequency when the larger scale clinical trial is designed. Very basically, this trial gives UCB researchers useful data for moving epratuzumab further down the clinical pipeline, giving people with lupus another glimmer of hope for a potential new therapy for the disease.

As Anna Novotney Barry, UCB's Clinical Program Director said, "This 12-week study was specifically aimed at identifying the best dose of epratuzumab, dosing regimen, and primary efficacy endpoint to take forward to the larger phase III confirmatory trials. We are delighted to report these positive results, which have provided essential data which create the foundation for our planned phase III clinical program."

This promising news about epratuzumab was made possible in part through your support of the Alliance for Lupus Research (ALR).  The ALR has strongly supported B-cell inhibition and depletion research, going back to some of our very first grants funded, now nearly ten years ago. Since inception, the ALR has funded almost $5-million in the area of B-cell research.

"Among the research efforts of many lupus investigators and along with support from many generous donors and funding sources, the research projects funded by the ALR have had a particular emphasis on control of B cells. These positive new data add to our growing sense that B cell research is bearing fruit. We will watch for future results from epratuzumab studies with great interest."

- Mary K. Crow, M.D., Chair, ALR Scientific Advisory Board

News Bulletin on Drugs in Development:

Epratuzamab shows novel positive effects in people with lupus in Stage IIb trial


Yesterday, two biopharmaceutical companies, UCB and Immunomedics, announced promising results of their phase IIb study for epratuzumab, their drug in development for treating systemic lupus erythematosus (SLE, or lupus). This is hopeful news for all those affected by this autoimmune disease.


Epratuzumab, developed by Immunomedics and licensed to UCB in 2006 for possible treatment of all autoimmune dieases, is a humanized anti-CD22 monoclonal antibody with the potential to modulate B cell activity. Although the exact role of CD22 in autoimmunity is not fully understood, it is considered to be a negative regulator of B cell function.


B cells are known to contribute to lupus by producing antibodies against the body's own cells and tissues, causing the immune system to turn on itself and resulting in the inflammation and tissue damage are the hallmarks of lupus. UCB and Immunomedic's released trial results showed that the treatment advantage of epratuzumab over a placebo reached 24.9% at week 12.


In other words: 227 people with moderate to severe lupus took part in this trial. Some subjects were given a placebo, and some were given epratuzumab. 24.9% of those given epratuzumab showed improvement in their symptoms over the 12 weeks of the trial.<AD NOTE: PLEASE LET ME KNOW IF THIS AN ACCURATE SUMMARY>


WHAT THIS MEANS FOR PEOPLE WITH LUPUS: 

UCB will better understand how to design a potential phase III trial studying many more patients. The results of the phase IIb study will help give UCB researchers confidence in determining best dosage and frequency when the larger scale clinical trial is designed. Very basically, this trial gives UCB researchers useful data for moving epratuzumab further down the clinical pipeline, giving people with lupus another glimmer of hope for a potential new therapy for the disease.


As Anna Novotney Barry, UCB's Clinical Program Director said, This 12-week study was specifically aimed at identifying the best dose of epratuzumab, dosing regimen, and primary efficacy endpoint to take forward to the larger phase III confirmatory trials. We are delighted to report these positive results, which have provided essential data which create the foundation for our planned phase III clinical program.

  

This promising news about epratuzumab was made possible in part through your support of the Alliance for Lupus Research (ALR).  The ALR has strongly supported B-cell inhibition and depletion research, going back to some of our very first grants funded, now nearly ten years ago. Since inception, the ALR has funded almost $5-million in the area of B-cell research.


There is no doubt that research supported by the ALR has brought us to the point where, for the first time in decades, many new potential agents for the treatment of lupus are in the clinical pipeline. This news from UCB and Immunomedics is a positive step in the right direction, and we will watch with great interest for updates on epratuzumab. 

- Mary K. Crow, M.D., Chair, ALR Scientific Advisory Board


About the ALR: The Alliance for Lupus Research (ALR) is the world’s largest charitable funder of lupus research. 100% of all donations to the ALR support innovative medical research focused on preventing, treating, and curing Systemic Lupus Erythematosus (SLE) or lupus because the ALR’s Board of Directors funds all administrative and fundraising expenses.


Be on the lookout for future updates from the ALR. Please feel free to forward this message to friends. To sign up for future updates, please send an email with "Subscribe" in the subject line to development.admin@lupusresearch.org.


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News Bulletin on Drugs in Development:

Epratuzamab shows novel positive effects in people with lupus in Stage IIb trial

 

Yesterday, two biopharmaceutical companies, UCB and Immunomedics, announced promising results of their phase IIb study for epratuzumab, their drug in development for treating systemic lupus erythematosus (SLE, or lupus). This is hopeful news for all those affected by this autoimmune disease.

 

Epratuzumab, developed by Immunomedics and licensed to UCB in 2006 for possible treatment of all autoimmune dieases, is a humanized anti-CD22 monoclonal antibody with the potential to modulate B cell activity. Although the exact role of CD22 in autoimmunity is not fully understood, it is considered to be a negative regulator of B cell function.

 

B cells are known to contribute to lupus by producing antibodies against the body's own cells and tissues, causing the immune system to turn on itself and resulting in the inflammation and tissue damage are the hallmarks of lupus. UCB and Immunomedic's released trial results showed that the treatment advantage of epratuzumab over a placebo reached 24.9% at week 12.

 

In other words: 227 people with moderate to severe lupus took part in this trial. Some subjects were given a placebo, and some were given epratuzumab. 24.9% of those given epratuzumab showed improvement in their symptoms over the 12 weeks of the trial.

 

WHAT THIS MEANS FOR PEOPLE WITH LUPUS: 

UCB will better understand how to design a potential phase III trial studying many more patients. The results of the phase IIb study will help give UCB researchers confidence in determining best dosage and frequency when the larger scale clinical trial is designed. Very basically, this trial gives UCB researchers useful data for moving epratuzumab further down the clinical pipeline, giving people with lupus another glimmer of hope for a potential new therapy for the disease.

 

As Anna Novotney Barry, UCB's Clinical Program Director said, This 12-week study was specifically aimed at identifying the best dose of epratuzumab, dosing regimen, and primary efficacy endpoint to take forward to the larger phase III confirmatory trials. We are delighted to report these positive results, which have provided essential data which create the foundation for our planned phase III clinical program.

  

This promising news about epratuzumab was made possible in part through your support of the Alliance for Lupus Research (ALR).  The ALR has strongly supported B-cell inhibition and depletion research, going back to some of our very first grants funded, now nearly ten years ago. Since inception, the ALR has funded almost $5-million in the area of B-cell research.

 

There is no doubt that research supported by the ALR has brought us to the point where, for the first time in decades, many new potential agents for the treatment of lupus are in the clinical pipeline. This news from UCB and Immunomedics is a positive step in the right direction, and we will watch with great interest for updates on epratuzumab. 

- Mary K. Crow, M.D., Chair, ALR Scientific Advisory Board

 


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