Data from Orban's Phase-I Trial
This research is a vaccine-like attempt to teach the body's immune system to stop attacking it's own beta cells. A molecule (insulin B chain) similar to insulin was given along with IFA (an adjuvant, a chemical that makes the immune system react more strongly to a vaccine) to try to train the immune system not to attack beta cells. This was a single injection during the honeymoon phase and patients were then followed for two years.
In terms of safety, the results were fine: nothing bad happened, and this is a new treatment, so safety was an important question. But in terms of effectiveness, the results are mixed. The vaccine did result in a specific immune system change that looks promising. The exact quote was:
The induction of a lasting, robust immune response generating autoantigen-specific regulatory T cells provides strong justification for further testing of this therapy in type 1 diabetes.But no effectiveness was seen during the trial. Their was no improvement in C-peptide generation of the treated group compared to the non-treated group. They were checked every six months. Dr. Orban works at the Joslin center.
Opinions
In my mind how you view these results says a lot more about your personality, than the results themselves. If you are an optimist, then you say "they proved safety, and they proved the treatment induced the change in the immune system the researchers were looking for so this is a success, and they should move on to phase-II testing to find a dose that will have a good effect on the person". If you are a pessimist, then you say "it did not effect the patient's C-peptide numbers, so there is no reason to think it will end up curing (or even improving) type-1 diabetes". The American phrase for this dichotomy is "Is the glass half empty or half full?"
But the truth is, that my opinion doesn't matter, and neither does your's. (Unless you happen to be funding Dr. Orban, of course!) If Dr. Orban gets funded for the next phase, then this study is a success on a path that might lead to a cure. If not, then it is a failure. That's not a very scientific view of success, but it is very pragmatic.
In the past, I know that ITN has discussed the possibility of doing a phase-II trial, but nothing ever came of it. I don't know why. Also, Dr. Orban has started his own company, specifically to bring this cure to market. Their web page is here: http://www.orbanbiotech.com/
The most recent news I have have from them is that in Nov 2010 they got a grant from the US Government: http://www.marketwire.com/press-release/orban-biotech-awarded-244000-qualifying-therapeutic-discovery-grant-from-us-government-1354039.htm
"Orban Biotech Awarded $244,000 Qualifying Therapeutic Discovery Grant From U.S. Government"
Abstract: http://www.ncbi.nlm.nih.gov/pubmed/19931408
Summary: http://www.immunetolerance.org/studies/autoantigen-vaccination-newly-diagnosed-type-1-diabetes-mellitus
Full Paper: http://www.immunetolerance.org/sites/files/2010.04_Orban_JAutoimmunity.pdf
(Thank you Immune Tolerance Network! For making this available on your web site.)
Clinical Trial Record: http://www.clinicaltrials.gov/ct2/show/NCT00057499
Joshua Levy
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions.
Blog: http://cureresearch4type1diabetes.blogspot.com
Web: http://joshualevy.pbworks.com/DiabetesCureReadyForHumanTrials
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