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Possible Cures for Type-1 in the News (late-Aug)

GCSF (Neulasta/Pegfilgrastim) Starts a Phase-I Clinical Trial
This is straight forward trial where GCSF is given to people in the honeymoon phase of type-1 diabetes.  It is interesting for many of the same reasons that the ATG+GCSF trial is interesting (see older post on ATG+GCSF).  Both of these trials are being done at the University of Florida, and Dr. Michael J. Haller is involved in both.

Clinical Trial Record: http://www.clinicaltrials.gov/ct2/show/NCT00662519

There is a second GCSF clinical trial being done at the University of Padova (Padova, Padua, Italy), but it is not aimed directly a curing type-1 diabetes.  Although I don't understand it fully, it appears to be more basic research into GCSF effects on people with type-1 diabetes.  Clinical trial record is here: http://www.clinicaltrials.gov/ct2/show/NCT01102699

A Little Discussion: Why a GCSF only Trial?
One obvious question that came to mind when I saw this GCSF only clinical trial, done at the same place and time, and by the same researcher as doing the ATG and GCSF trial, was: why do both?  I mean, if GCSF works, then certainly ATG and GCSF will work, and clinical trials are a lot of work and expense.

The answer to this question (for me) has to do with with three separate, but related goals:

  1. We want to cure type-1 diabetes. (Cure Product Development.)
  2. We want to learn how drugs effect type-1 diabetes, so we can find a cure.  (Basic research.)
  3. We want the FDA to approve clinical trials which lead to points 1 and 2.
If you only look at point 1, then a GCSF-only trial (when a GCSF+ATG trial is also ongoing) might sound like a waste of time.  As a parent of a child with type-1 diabetes, I often focus only on point 1.  However, product development flows out of basic research, so points 2 and 3 are also important.  It may turn out that studying GCSF alone will help create a cure in the future, or that the FDA might require more knowledge of GCSF alone before it will approve some future clinical trial, which leads to finding a cure.

In the past I have blogged about not understanding how  Sitagliptin alone, or Sitagliptin and Lansoprozole combined, could cure type-1 diabetes.  However, it may be that these clinical trials will be valuable, because of points 2 or 3 above.  They might be the basic research or FDA required background that eventually leads to a cure, even if they are not the cure themselves.

LCT Announces Completion/Extension of their Phase-II Trial
LCT has announced these things in August:

  1. Their phase-II trial has been extended with 4 new patients who will get dose 20k u/kg dose.  The phase-II study now includes 4 who got 10k u/kg, 4 who got 15k u/kg and these 4.  This is a 50% expansion of their study, at 33% higher dose.
  2. The first four patients have seen a benefit of fewer (or elimination) of low BG episodes.  Only two such events, compared to nineteen, so almost a 90% drop.
  3. They plan "commercial launch" in 2013, and "global reach though partnership".  They seem to be assuming that the operation will cost about $150k (I think this is US$, but not sure.)
  4. They have also laid out the following time line for getting to commercial availability, which is the most detailed that I've seen:
  • 2011: Continue phase-II trials, get approval for phase-III trial (They use the term "pivotal".)
  • 2012: Complete phase-III, report on results.
  • 2013: "Approval and revenue"
That's their plan, and I hope they make it.  I see the following issues for them to overcome.  First, they need to have a cure.  Right now, the longest they have had anyone insulin-free is 32 weeks, and only two people (out of twelve) have been insulin free for any number of weeks.    Obviously they need to improve both of these numbers.  (Although, if you view them as a treatment to help brittle diabetics, then their results might be good enough already - depending on how long they last - but that wouldn't be a cure.) Second, they need to treat enough people to get their approvals.  Right now, they have treated a total of 16, with 4 more on the way.  That is far fewer patients than any other phase-II trial that I know of.  A more common count is 20-30 in the phase-I trial, 80-120 in phase-II, and 300 in a phase-III "pivotal" trial, and then a second phase-III trial for confirmation.  (Basically all the drugs in phase-III trials have followed that path.)  LCT is running at about 1/3 the size in their phase-I trial, and 1/10 the size in their phase-II.

Press release: http://www.blogger.com/post-edit.g?blogID=5472921328078253036&postID=548554300707664816
Corporate Overview: http://www.lct.com.au/downloads/cms_latest_news/2010-08-26-Presentation%20August%2010.pdf
This corporate presentation contains a lot of information on where they are, what they plan to do in the future, and how they plan to make money.  It is targeted at investors, after all.

NovImmune has started a phase-II for NI-0401
This company is very hard for me to follow, because they don't issue many press releases, don't have the clinical trial records, that most other researchers have, and it is just generally hard to find information on them.  The  are a small, relatively new company and their lead product (the one farthest along is the drug development process) is NI-0401 which is and anti-CD3 drug, generally similar to the Teplizumab and Otelixizumab

Their recent corporate literature makes it clear that NI-0401 has started a phase-II clinical trial for type-1 diabetes.  Unfortunately, I have not been able to find clinical trial records for either the phase-I or phase-II trials, so I have no ideas how many patients are involved, if they are honeymoon or not, or any other of the most basic information about the study.  Even worse, I can not find any published results for the phase-I study in type-1 diabetics.  (I did find results for their phase-I trial on Crohn's disease, but not tyoe-1.)

Corp presentation: http://www.swissequitybiotechday.ch/media/biotechday/downloads/novimmune.pdf

AP News: Faster Insulin
Below is a link to a JDRF press release on their project to created faster acting insulin (mostly to help their Artificial Pancreas project):
I normally would not cover it, because it doesn't talk much about results or progress, however I did want to mention it because it is much broader and contains more context than your usual press release.

Most press releases just cover one piece of news for one line of research, but this press release gives a lot more useful context to the search for faster acting insulin.  Basically, it starts out with a goal.  The goal is to get faster acting insulin, mostly because it will make creating an artificial pancreas easier, and make the resulting pancreas better.  (Obviously,  it will also help everyone who uses insulin with meals, which is basically all type-1s.)  The simplest way to speed up insulin (and the way done in the past) is to create a new form of insuilin which is faster than the currently available forms.  And JDRF is funding Dr. Buckingham at Stanford to test one of those.  Another way is to find a faster pathway into the body.  So JDRF is funding Dr. Zisser testing of AFREZZA, which is inhaled insulin; the hope is that inhaled equals faster.  A third idea is to use microneedles to deliver insulin faster (JDRF is working with BD on this one).  A fourth is a port-system which puts insulin from a standard pump directly into a person's liver.  Since insulin mostly effects the liver, this could speed up the effectiveness of pumped insulin.  (JDRF is working with Roche on this.)  Finally, there is a post-pump insulin warmer which might also speed up insulin effectiveness.  (JDRF is funding Dr. Tamborlane of Yale to test this for InsuPatch.)

My Opinions.....
The whole point of research is that you don't know which projects are going to pan out and which are not.  This press release shows how JDRF is trying many different possible paths to faster insulin.  Some of those paths seem like good ideas to me.  Others seem very inventive, if a little strange.  Others don't strike me as unlikely to succeed.  I'm sure other people looking at the same list will expect different research to fail and succeed than I do.  That is why JDRF is funding all of them.  No one knows which will pan out.  I believe that this whole project is part of JDRF's "glucose control" research area, and that whole section includes about 6% of their funding.  So even though it sounds like a lot of different research projects in different areas (and it is!), all together it is only a few percentages of JDRF's total investment.   It doesn't even begin to touch the 33%+ aimed at immune therapies or the 40% aimed a regrowing beta cells.

JDRF Page on Spending: http://www.jdrf.org/index.cfm?fuseaction=home.viewPage&page_id=0B36CA86-9128-4C49-B7D8F55955507931

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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