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.