I didn't quite get this out by the end of May, but it is the May update.....
Andromedia Starts DIA-AID2: Second phase-III Trial of DiaPep 277
Andromedia just (in April 2010) started their second phase-III trial, which will enroll 450 people and is planned to last until March 2014. Both the EU and the US require two large scale trials for approval of new drugs, so if this study and their earlier DIA-AID trial both work well, then the approval process can start mid-2014. It usually takes a year or two for marketing approval, so 2015 or 2016. This treatment has only been tested on honeymoon diabetics.
Neither this treatment nor ToleRx's (described below) will cure people by themselves. They are both attempts to preserve some beta cells and so either extend the honeymoon or make the continuing diabetes "less brittle" in terms of fewer quick BG drops. In both cases, I need to put together a blog posting on exactly how effective they were in their phase-II and early phase-III results.
Andromedia's DIA-AID2 page: http://www.andromedabio.com/clinical_trials.php
Clinical Trial Record: http://www.clinicaltrials.gov/ct2/show/NCT01103284
ToleRx Starts DEFEND-2: Second phase-III trial of Otelixizumab
This must be the month for starting second (sometimes called "confirmatory") phase-III trials, since ToleRx is also starting one of these. The news is just as good as Andromedia. Actually better, since ToleRx hopes to finish their second phase-III by May 2013. The study will have 396 people. The same market approval math works here, so 2014 or 2015, but only if they finish their second phase-III as expected, and with the results they expect. Both of their phase-III trials are limited to honeymooners only (so any approval would only be for newly diagnosed). Their phase-II clinical trial (called "TTEDD") did enroll non-honeymooners. However, it looks like good results were only seen for honeymooners (but I don't have the details handy). That would explain why their phase-III trials are all honeymooners only.
TolerRx's DEFEND-2 page: http://www.clinicaltrials.gov/ct2/show/NCT01123083
Clinical Trial Record: http://www.clinicaltrials.gov/ct2/show/NCT01123083
Data from XOMA Phase-I on Behcet's Disease
Previous blogging on XOMA 052: http://cureresearch4type1diabetes.blogspot.com/search/label/Xoma
Current Status on XOMA 052: http://joshualevy.pbworks.com/DiabetesCureReadyForHumanTrials#Xoma052byXoma
Behcet's Disease is an auto-inflammatory condition, which is rare in the US, but more common in Turkey. Since XOMA 052 is an anti inflammatory, it is a natural drug to test on the disease. It's of interest to people with type-1 diabetes because XOMA 052 is also being tested for both type-1 and type-2 diabetes (in separate phase-II trials). Link to why inflammation might be a cause of diabetes:
http://joshualevy.pbworks.com/ConceptsAndBackground#Inflammation
(but remember that this is a minority opinion).
So, with all that a background, their results are very good (but on a very small group of people). This trial only included 4 people. However each person involved showed real improvement to their Behect's symptoms.
My take on this research is as follows: It shows that XOMA 052 has a major impact on inflammation in a situation similar to (but not identical with) type-1 diabetes. So, if inflammation is a causative factor, or if reducing inflammation allows the pancreas to regrow, then XOMA 052 has a good chance of being successful.
Also, there is news about Xoma's phase-II trial in type-1 diabetics. They have changed it considerably from the last time I looked. It is a 24 person study, which started in Feb 2009 and is expected to finish in July 2011. Since it lasts a year, if they finish enrollment in July 2010, then they will be on track to finish the study a year later. This trial is open to non-honeymoon diabetics only, but there is only one site: Zurich, Switzerland.
So there are now at least two phase-II trials aimed a curing diabetes via anti-inflammatories, and they will both have results in 2011, so that might be a pivotal year for the whole idea of cures based on anti-inflammatories.
News: http://www.marketwatch.com/story/abstract-published-on-initial-results-from-xoma-052-clinical-trial-in-behcets-disease-2010-05-12?reflink=MW_news_stmp
Abstract: https://b-com.mci-group.com/Abstract/Statistics/AbstractStatisticsViewPage.aspx?AbstractID=19942&ItemsPerPage=20&AppliedFilter=[SubmitterFullName]%20Like%20%27Ahmet%20%%27&ShowOnlyInFinalAcceptance=true
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.
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