Omni Bio announced that the Barbara Davis Center for Childhood Diabetes has received IND (Investigational New Drug) regulatory clearance from the U.S. Food and Drug Administration (FDA) to start a Phase I clinical trial evaluating Alpha-1 Antitrypsin ("AAT") in patients with type I diabetes.
This is an anti-inflammatory drug, which the body makes naturally, and which is already FDA approved for people who have a rare condition where a person don't make enough of it on their own. You can read my general comments about all inflammation based cures: http://joshualevy.pbworks.com/ConceptsAndBackground#Inflammation
There is not yet a clinical trials record for this, but the press release says they will start out with 15 people in a phase-I trial, and will try to expand to a 50 person phase-II study. This is all being done at the Barbara Davis Center in Denver. People in the trial will get the drug for 8 weeks, and then be followed for 2 years. It is not clear if this will be honeymoon only, or established diabetics only, or both.
Press release: http://www.omnibiopharma.com/admin/files/file/OMBP%20IND%20CLEARANCE_JEFFERIES_FINAL%206%208%202010.pdf
Corporate web site: http://www.omnibiopharma.com/
Welcome a new treatment and a new company to the world of clinical trials to cure type-1!
One of the questions that I often get asked about mice cures is "how long until this is available for people". My stock answer is "for a new drug, at least 10 years from the start of human testing (clinical trials)". That's a true answer, but not a complete answer, because they are usually asking right after the announcement of a successful mouse trial, but before any human trials have started. So part of the answer is how long does it take to go from the end of animal trials to the start of human trials.
This research has taken almost exactly 2 years to make that transition from animal testing to human testing. So that is one solid data point on how long it takes. But remember, this drug is already FDA approved for another disease, so it is probably quicker at making the transition, than a previously unapproved drug.
One Year Delay on Dr. Faustman's Results
In May 2010, Faustman's Lab updated their FDA clinical trial record to reflect these two new dates:
Estimated Primary Completion Date: December 2010 (Previously it had been December 2009)
Estimated Study Completion Date: February 2011 (Previously it had been Feburary 2010)
No other updates were made.
So this represents a one year delay in completing their phase-I study. The first date is the "data complete" date, when they hope to have gathered all the data needed for the study. The second date is the date when everything associated with the study will be completed. I think it is fair to say that the second date is the earliest possible publication date for the results, although the actual publication date is likely to be months after that. The only good part of this news, is that we have already waited through a couple months of the delay, so we only have about a year to wait. (I"m assuming that if the study is complete in February, it will get published later than same year.)
This is only the latest in a long line of delays for Faustman's phase-I study. It was originally expected to take 7 months and be completed in July 2008. After a series of four delays, it is now expected to take about 37 months (if it meets it's December 2010 date). In late 2007, they thought they were about 7 months away from data completion, and now, in mid 2010, they still think they are about 7 months away from completion. (Actually, that's closer to 3 years without forward progress.) One way to look at this, is that they have made no visible progress in completing their phase-I trial in the last 2+ years.
Personal opinion: I think that for any research study where delays have been over four times longer than the original total length of the study (7 months of original length vs. 30 months of delay), that study is in real trouble. And especially, this study, which only involves studying 25 people for 3 months each. At it's heart, it is a small, simple study, using an already approved drug. What could cause it to take 5 times it's original length, and still not be complete? In a future blog entry I hope to write about what could cause such a delay. But as a "teaser," I don't see how it could be just one problem. The worst single problem you might have might double the length of your trial, because you would have to restart from the beginning. But this trial is about 5 times longer than initially expected. Also, at least once, the delay occurred after recruiting was complete. The only way that could happen is there was a problem with the data gathered, so it had to be gathered again, or if the problem was found during data analysis.
The Lee Iacocca foundation is now funding Kineta. Later this year, Kineta hopes to start human trials on SK-186, which is a inflammation based treatment for type-1 diabetes. Here is the rational for this drug:
ShK-186 is a potent and highly specific Kv1.3 potassium channel blocker. It is designed to suppress activation of effector memory T cells, which are important mediators of inflammation and tissue damage in MS, type 1 diabetes mellitus and other autoimmune diseases. The drug candidate has been shown to significantly reverse disease in animal models of MS and rheumatoid arthritis. Animal models also have demonstrated that efficacy is achieved without the generalized immunosuppression that occurs with competing therapies.You'll notice that they don't report any success for type-1 diabetes in animal models. As above, remember my general comments about all inflammation based cures: http://joshualevy.pbworks.com/ConceptsAndBackground#Inflammation
There are currently four other inflammation based cures in clinical trials (including AAT, above). Even a few years ago, there were none at all, so this is a growth area of research.
Press release: http://www.kinetabio.com/press_releases/PressRelease03292010.pdf
Corporate web site: http://www.kinetabio.com/
Request for Help
I'm trying to track down information on a clinical trial of NI-0401 by NovImmune, a Swiss company. The company is very specific that a phase-I trial has started in the Netherlands, and I've seen other references to the trial as well. But I can not find any official record of it. No clinical trial record, and no registered trials record, either. Does anyone know anything about this trial? NI-0401 is supposed to be an anti-CD3 humanized monoclonal, so much like Otelixizumab and Teplizumab.
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions.