Dew, Recently Geron reported the results of several of their phase one studies utilizing Imetelstat (GRN 163L), a telomerase inhibitor, I know you would be familiar with Dr. Elizabeth Blackwell's Nobel prize winning work on telomeres and the notion that cancer stem cells have short telomeres and may be uniquely approachable with telomerase inhibitors of which Imetelstat is one (?the only in clinical trials.) Anyway my question is this. Wading through the usual drek on the YMB I came across two reasonable posters each of which making two astute observations (cjbradely and champion I think were there board names). One was that although the patients in the studies had failed other regimens and radiation where appropriate it appears that they were followed for some time (not clear from the presentation how long) and study data was reported in almost all the patients (that is maybe they didn't die so fast?), is it possible that some unstated mortality effect was present and not enumerated since the study was just a phase I for safety, dosing etc. The other was that one study I think still a phase one had the n increase from 48 to 80 something in Oct and is still ongoing now to terminate in March of 2010. My question is could they be going for some demonstration of clinical effect even though as a phase I it was presumabely structured as a safety and dosing study? Why else double the number of enrollees? Do you have any knowledge of a phase I study that demonstrated efficacy or was modified midstream to try to do so? Maybe I am reading too much into this but it does seem unusual and I wanted to get your take on this. Thanks, bp
