Interesting Comments from Neurocrine CC
To note: for their next PII trials, they are using different endpoints, have dropped a 75 mg dose in favour of a 250 mg dose, are talking about a large placebo effect and have changed the forumulation of the pill. Other than that, no warning signs!
The study that was started this winter with an investigator meeting in January is the so-called 702 study, also known at the Lilac Petal Study. And this trial is a very important trial for us, in that it – it is planning on enrolling 150 women with moderate severity endometriosis. And most importantly, it incorporates for the first time, modification of the clinical end points as recommended to us by the repro division of the FDA. So we'll have a chance to test their recommended assessment method.
We are including a higher dose than we have used before, a 250-milligram dose in addition to the already shown to be effective 150-milligram dose. And we are taking advantage of recommendations from the NIH, and the American Society of Reproductive Medicine Guidance on endometriosis trial designs and we are including a placebo single-blind wash-in period. This should help counter balance, if you will, the placebo effect that we and other companies in trials have seen in endometriosis trial. This trial is intensely active right now with 50 study sites up and running in the U.S., and we anticipate enrolling the last patient late summer, and then top-line readout of efficacy results with the new scales, the higher dose, the commercially viable tablet formulation, all in the first half of 2009.
Now, most recently and the focus of a lot of work on the team's part right now is the so-called 703 study. This is a trial that is set currently getting up and running in central Eastern Europe. And this is an important trial in that in addition to employing the higher dose, the 250-milligram in addition to the 150-milligram dose, we are including a Lupron or leuprolide depot injection as well as placebo in this trial for several reasons. One, we need some ex-U.S. experience as the regulatory and clinical operations aspects of studies are different in this environment; two, the enrollment capacity is much more rapid. That is the recruitment and enrollment of subjects in these trials typically is more rapid in central Eastern Europe than it is here in the U.S.; and thirdly, we are very interested in getting a – some statistical information about the difference between Lupron and placebo to the extent that we expect at least in European registration trials that we will be carrying out a non-inferiority trail design in the pivotal phase of this development program. And to do a proper non-inferiority trial, you have to have adequate statistical understanding of the margin of your active comparator.
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