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  • michaelplongo michaelplongo May 21, 2013 11:14 AM Flag

    UBS presentation excerpts from Seeking Alpha transcript

    Some important excerpts from the Seeking Alpha transcript of the UBS conference presentation on May 20. From what I read, you need 10% hypomethylation for AML response, and Vidaza is typically less than 10%, so no Vidaza threat in the AML arena. Also, if SGI-110 is helping people who fail Vidaza or Dacogen or both, AND it is safer , AND it has a longer half life/duration of effectiveness, then SGI-110 could possibly replace both drugs for first line MDS and be the only possibility for second line MDS and ALL AML indications.

    Hey buckethead, Manuso said “And so therefore, we're looking at first line MDS or AML and relapsed refractory AML or MDS.”

    SGI-110 the Phase I clinical results the pharmacodynamics here to LINE-1 demethylation. What we found is that as you increase the dose up to 60 milligrams per meter squared, we're getting increasing degrees of hypomethylation, and then it kind of tops out, so that even if you go beyond that dose, you're still in that general range of 20% to 25%. This, by the way, distinguishes the drug from both Vidaza, which typically has less than 10% hypomethylation and from Dacogen, which is less than 20%. We've actually seen LINE-1 demethylation on the order of 35% with an outlier patient. So it's certainly doing the job of hypomethylation.
    Now the responses in relapsed or refractory MDS are represented here.

    Out of 15 patients, we had 5, who were total MDS responders. And these are the patients, who were previously treated with azacitidine or decitabine. And some of them had multiple categories of response. So, again, small numbers but a very early on, and then if you take a look at the relapsed refractory responses versus demethylation in AML, what we discovered was that you really had to have greater than 10% demethylation in order to have a response. So this harkens back to the fact that you want to assure that the patients are dosed properly in order to get the degree of demethylation in order to have a response.

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    • So the dose expansion phase, about 200 patients randomized. And we will have data at ASH later these year in the relapsed refractory AML population. We'll also know, on an early basis, what the data look like in the remaining 3 populations. And we'll make a decision as to where we're going to go in the Phase III. But we'll announce where we're going in the Phase III later this year.

      He went on to state:
      So what I have attempted to convey to you here is that SGI-110 is not Dacogen, it's not azacytidine, it's a very different drug. The clinical activity I think speaks for itself in MDS and AML. We've seen responses in very sick patients frankly, and pretreated significantly. And it's the only new hypomethylating agent that is in advanced clinical development at this point in time.