Friday, May 29, 2009

Exsulin: New Phase-I Research Almost Ready to Start (for Non-Honeymoon Type-1 Diabetes)

The Exsulin company is hoping to start Phase-I human trials in June 2009 (so right soon now). They are testing a new formulation of INGAP called Exsulin, a drug designed to regrow beta cells in the pancreas.

Their Phase-I clinical trial is small, short, and open to people who have had type-1 diabetes for more than 2 years, so we should have some results soon. It is a three group design. One group gets nothing, one gets a full dose, the other gets a half dose. They are checking for all the right stuff: C-peptide, fasting glucagon, fasting glucose, total daily insulin dose, and HbA1c. They are using two sites Montreal and Rochester.

This is described on their web site:
http://www.exsulin.com/underway.html

INGAP (now renamed Exsulin) has a 12 year history of research. NOD mice trials worked well, but human trials didn't show much success (sound familiar?) The phase-I study is described here: http://www.clinicaltrials.gov/ct2/show/NCT00034255. The phase-II study is described here: http://www.clinicaltrials.gov/ct2/show/NCT00071409. It was funded by Proctor and Gamble but the results were not good enough to move forward.

The original developers of INGAP got back rights to it after P&G didn't like the phase-II results. Their analysis of the results convinced them that INGAP was helping grow new beta cells, but that those new cells were being killed off too quickly to help the patient. (Maybe because of the body's immune system, or maybe because of inflammation, or maybe for some other reason.) So it is natural for them to pair Exsulin with another drug to treat the other problem, and see if both together can cure type-1 diabetes. But the research they are starting now is just Exsulin, not paired with anything.

Joshua Levy

7 comments:

David said...
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David said...
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Anonymous said...

If Exsulin (INGAP) is going to regrow beta cells, I think they'd better stop the immune attack first. Otherwise looks like growing food for the T-cells. Or either they have great faith in the ongoing phase II/III immune modulators (Diamyd, Teplizumab, Tolerx), or INGAP has the double effect of stopping the attack and regrow. How do they plan to demonstrate that beta cells can be regrown if they'll be destroyed by the T-cells? Any insight here?

Joshua Levy said...

For Anonymous: I don't have any insight into the question you ask. I think that is why INGAP failed the last time around (they couldn't demonstrate the benefit of INGAP alone, and they didn't test it with anything else).

Joshua Levy

Joshua Levy said...

David: I'm deleting your two comments because they have nothing to do with the posting. This blog is about curing type-1 diabetes (not causes).

Joshua levy

Scott said...

Diabetes writer David Mendosa did write in 2006 that Kinexum's Dr. Fleming and his company had analyzed P&G's Phase 2 trials and concluded that they were poorly designed. So Kinexum (now Exsulin) was going back to the drawing boards with more trials.

Dr. Fleming said that he believed that INGAP Peptide "offers excellent prospects for a breakthrough therapy and the achievement of a major scientific milestone." He told David Mendosa that it will help both people with type 1 diabetes and those with type 2 who use insulin.

"If you look at the Procter & Gamble type 2 study, you will see that there was nearly a 1% improvement in A1C," he said.

According to Exsulin's website, the "next Phase 2B Human Trial Begins Q2 2009 at McGill University and the Mayo Clinic", although beyond this little tidbit of information, it's unclear whether this is for Exsulin alone or a combination of Exsulin and LSF, but the combo trial of these 2 drugs was announced at the ADA Scientific Sessions in 2006, so its definitely coming ... they main question is when and where?

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