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...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... 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...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... 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...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... 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.  More

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