[acb-diabetics] FW: Interview with Tolerx's Dr. Lou Vaickus

Wed Aug 18 15:41:45 GMT 2010

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From: Diabetes In Control [mailto:diabetes at topica.email-publisher.com] 
Sent: Tuesday, August 17, 2010 11:30 PM
To: plawolf at earthlink.net
Subject: Interview with Tolerx's Dr. Lou Vaickus

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Over the past ten years we have seen a whole lot of "cures" for diabetes.
When I was president of the Tampa Bay chapter of the Juvenile Diabetes
Research Foundation, every year we would be tantalized by the newest cure
for Type 1 diabetes, at the annual meeting, only to keep hearing "maybe next
year."  Recently I had the chance to speak with Lou Vaickus, MD, Chief
Medical Officer of Tolerx.  His company has a new product, otelixizumab, an
anti-CD3 monoclonal antibody, that has entered Phase 3 Trials for the
treatment and reversal of the autoimmune process in Type 1 diabetes.  After
speaking with him I felt that I should share some of the information he gave
me. 
Dave Joffe 
Editor-in-chief 

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Dr. Lou Vaickus has been Chief Medical Officer of Tolerx since November 2004
and has served as Vice President of Clinical Development and Medical Affairs
since July 2002.  He has over 30 years of experience in the preclinical,
clinical, and post-marketing research and development of biologics and small
molecules as a research scientist, academic physician, and pharmaceutical
executive.  He holds an M.D. from Loyola University's Stritch School of
Medicine and completed an Immunology Fellowship, Internal Medicine training,
and Hematology and Medical Oncology fellowships at the Mayo Clinic,
Rochester, Minnesota and Stanford University Medical Center,
Stanford,California 

  _____  

DJ:  Why do you think a cure for Type 1 diabetes has yet to be
commercialized?

LV:  Cure is a tall order in any chronic disease process.  For Type 1, that
involves both knowing when someone first has evidence of Type 1 (we do not
have a good surrogate marker) and then having the right therapies to combat
it before it destroys all of the insulin-producing beta cells in the
pancreas... <http://diabetes.c.topica.com/maaoaLLabZDlObtiuftcaeQyvr/> More

DJ:  How does the (anti-CD3 monoclonal antibody) drug class function?

LV:  No one knows the exact mechanism, but we at Tolerx have an educated
guess based on a lot of work in animal models and preliminary human data.
Anti-CD3 antibodies are thought to have a twofold mechanism of action...
<http://diabetes.c.topica.com/maaoaLLabZDlPbtiuftcaeQyvr/> More

DJ: What are the tradeoffs?

LV:  All drugs have side effects and almost all of these side effects are
dependent on how much of the drug you get, especially for drugs that
modulate the immune system.  So, understanding the optimal dose is
crucial... <http://diabetes.c.topica.com/maaoaLLabZEpNbtiuftcaeQyvr/> More

DJ:  What distinguishes otelixizumab from other drugs in its class?

LV:  The first thing that distinguishes otelixizumab is that we took many
years to study it and identify an optimal dose before we started pivotal
Phase 3 clinical trials.  We evaluated our product up, down, and sideways...
<http://diabetes.c.topica.com/maaoaLLabZDlRbtiuftcaeQyvr/> More

DJ:  What kind of results have you seen so far?

LV:  We are bullish about our chances for a good outcome with otelixizumab.
In nonhuman animal models of Type 1 diabetes the standard published dose of
an anti-CD3 antibody was a "high dose."  So we have drastically lowered the
dose there... <http://diabetes.c.topica.com/maaoaLLabZDlSbtiuftcaeQyvr/>
More

DJ:  Will there be any application of this drug class for Type 2 diabetes?

LV:  Fascinating question!  There have been very early studies to suggest
that many of the problems that Type 2 diabetes patients have (increased
heart disease and insulin resistance as examples) have their origin in an
immune response in abdominal visceral adipose tissue that promotes
inflammation and hence, damage to many organs.  In one study in mice, an
anti-CD3 antibody, given as a single treatment course for a short period of
time (just like in Type 1 patients with otelixizumab), resulted in durable
effects on insulin resistance.  So, the answer here is ... stay tuned...
<http://diabetes.c.topica.com/maaoaLLabZDlTbtiuftcaeQyvr/> More

DJ:  What is the anticipated timeline for commercialization if all goes
well?

LV:  We plan to submit all of our results to FDA (and afterwards to other
regulatory agencies in Europe and elsewhere) at the end of 2012.  The review
of these results can be as short as 6-10 months or as long as 12-15 months
before we hear whether our application is acceptable or not.  If it's
approved, then we can begin marketing our product as a safe and effective
treatment to preserve insulin production in patients with recently diagnosed
Type 1 diabetes.
<http://diabetes.c.topica.com/maaoaLLabZIR2btiuftcaeQyvr/> More

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