Sunday, October 19, 2008

JDRF Funding of Cure Research (phases II and III)

I was talking to someone today, and when I told him that I track cure research for type-1 diabetes that was being tested in humans (ie. "in clinical trails"). He asked me a question that really surprised me. He asked "Do you follow all cure research, or just the stuff funded by JDRF?" My answer was "I follow all research; however there's not much difference, because over their years of development, JDRF has funded almost all of the possible cures being tested in people today."

That's a strong statement, and I made it off the top of my head, without my notes in front of me. But in the evening, I double checked, and it is pretty impressive. JDRF has funded every cure currently in phase III human trials and every cure currently in phase II human trials. I haven't had time to check on all the phase I trials, yet. But still, 100% funding rate for the two phases of research closest to a cure is something to be proud of.

So lets look at the data.

Currently in phase III clinical trials are Diamyd (GAD65/DiamydT), ToleRx (TDX4), and Andromedia (P227). JDRF paid for early academic research on all three of these cures, and is directly funding ToleRx's phase III trial.

Currently in phase II clinical trials are Osiris (PROCHYMAL), Macrogenics (teplizumab), Transition Therapeutics (E1/G1), Pescovitz (Rituximab) and Gitelman (Thymoglobulin).
JDRF is helping to fund the clinical trials for every one of these, and funded some of the academic research on E1/G1. (They might have funded earlier research on Thymoglobulin and Teplizumab as well: I don't follow animal testing very closely, so am not sure where that funding came from.)

Currently there are about 10 phase I clinical trails, and I have not checked to see how many were funded by JDRF and how many were not. So that information will need to wait for a future posting. I can see that at least one was not funded (LCT), and at least two were (the Haller/Schatz work at Univ. of FL and Trucco's work at Pittsburg).

Some notes to remember:
1. All of the phase II and III cures are targeted at new-onset diabetics (we would call them "honeymoon" cures. They only work on people diagnosed a few weeks ago. There are a couple of non-honeymoon cures in phase I testing right now, but none farther along.
2. Some people think of Macrogenics's current trials as phase III rather than phase II. Officially, they call them "Phase II/III" so you can take your pick.
3. I consider JDRF to have helped fund the cure if they funded any part of the academic or commercial research that led directly to the current clinical trial. For example, I don't think that Diamyd the company has gotten any money from JDRF, but JDRF did fund some of the early GAD65 research which led directly to their human trial.
4. The Andromedia cure, which is called P227, has not made any forward progress in years, and does not look very promising right now, but it is in phase III trials, so I include it above.
5. Faustman considers her current work to be phase I, so I will discuss it when I cover all the phase I trails.

If you have any questions on this, or you think I've missed something, please don't hesitate to ask the question, or call out what you think I missed.

Joshua Levy

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