ICT-107 update dated july 2, 2012 ...........increase from 102 patients to 123,, "randomized'
July 2, 2012
ImmunoCellular Provides Update on Phase II Clinical Trial of ICT-107 for Treatment of Glioblastoma
LOS ANGELES, CA – ImmunoCellular Therapeutics, Ltd. (“ImmunoCellular” or the “Company”) (NYSE MKT: IMUC), a clinical stage biotechnology company that is focused on developing new immune-based products to treat cancer, announced today that it will expand its current Phase IIb trial of ICT-107 from 102 to up to 123 patients with glioblastoma multiforme (GBM) and who are HLA-A1/A2 positive. There are currently 231 patients enrolled in the study and more than 105 patients have either been treated or are scheduled to be randomized and treated over the next few weeks. The Company expects to complete the expanded enrollment within the next 60 days.
“We believe that the increase in the number of patients may further validate the study, and accelerate the path to data analysis,” said Manish Singh, Ph.D., President and CEO of ImmunoCellular Therapeutics. “The additional patients could also provide for a more robust and meaningful trial.”
The Phase IIb trial of ICT-107 is a double-blind, placebo-controlled, 2:1 randomized study designed to evaluate the safety and efficacy of ICT-107 in patients with newly diagnosed GBM. The study has been enrolling patients at medical institutions in collaboration with leading experts and opinion leaders in neuro-oncology at those sites. An interim analysis is expected when 32 events have been observed. As the final analysis will be event-driven, increasing the number of patients treated, the Company believes it may shorten the trial by a few months compared to treating only 102 patients. This should also provide more information for robust sub-group analysis of the trial results, as differences in age, degree of resection, and other factors can impact overall survival.
In the Phase I clinical study of ICT-107 in GBM, 16 newly diagnosed patients who received the vaccine in addition to standard of care treatment of surgery, radiation and chemotherapy demonstrated twoyear overall survival of 80 percent and a three-year overall survival of 55 percent. These figures compare favorably to the current 26 percent two-year overall survival and 16 percent three-year overall survival based on the historical standard of care treatment alone. Updated data from the 16 patients in the Phase I trial shows that patients treated with ICT-107 reported overall survival (OS) of 50% after four years and 38% of the trial patients are progression free (PFS) for 48- 66 months. This compares very favorably to historic mean OS of 12.1% after four years and 5.6 % PFS after 48 months with standard of care alone. The clinical centers currently recruiting for this clinical trial and enrollment criteria are listed at
phishes3, you may very well be the first biostatistical guru on a yahoo message board ever to post reasonable projections.
the guys on the onty board were predicting for a 2 year survival advantage, there was none. failed trial.
The accuracy of a model depends on reliable data and reasonable assumptions. The quality of those data and and assumptions are critical to a model's success. But even with good data and reasonable assumptions you can never be "sure" about success. As one famous modeler on the IHub said: "Schit happens."
Fred - I agree 100% and that is one reason why I'm as transparent as possible with my data/assumptions and encourage others to give me their feedback and thoughts. But even with 100% accurate data and NO assumptions there is still a significant amount of variability in model outcomes due to factors that can't be known (just by pure chance - will the first few people enrolled in the trial be the ones that will live the longest - this could push the 32nd and 64th event dates out past a date in which a model shows success - but in reality may not show any benefit to OS. This is one reason why I put date ranges and probabilities to those ranges.)