The below paragraph from the CEGE 07/10/2007 PR gave a hint of why Vital-1 might be turning out not as CEGE expected. The phase 2 data were based on rather healthy patients as predicted by nomograms. Vital-1 patients might track the normal HRPC population with nomogram-predicted survival time below 20 months. Who knows whether or not the high medians would hold up in that case.
Cell Genesys' ongoing Phase 3 GVAX immunotherapy for prostate cancer program is supported by the median survival results from two, independent, multi-center Phase 2 clinical trials in approximately 115 patients. The subset of patients in these two trials who received the doses comparable to the Phase 3 dose showed median survival of 34.9 months and 35.0 months, respectively. These results also exceeded the predicted survival of 22.5 months and 22.0 months, respectively, as determined by a seven point patient disease characteristic nomogram. The results of the first trial were published in the July 1 issue of Clinical Cancer Research. Results from both studies compare favorably to the previously published median survival of 18.9 months for metastatic HRPC patients treated with Taxotere chemotherapy plus prednisone, the current standard of care.
Also note the bogus comparison of the benefit of GVAX shown in the phase-2 data vs. that of Taxotere shown in a much sicker population. The predicted survival time of patients before GVAX treatment was already better than the actual survival time of patients treated with Taxotere. Should that not tell them that the comparison was invalid due to wildly different patient populations? If this sort of sloppy thinking was a part of the trial design process...
