ImmunoCellular Therapeutics (AMEX:IMUC) Monday announced it is expanding its current phase 2b trial of its tumor vaccine in an effort to “further validate the study” and possibly short the trial by a few months.
The bio tech firm said
that the trial will be expanded to include 123 patients, up from 102,
that have either been treated or are scheduled to be randomized and
treated over the next few weeks with its ICT-107 vaccine – for the
treatment of an aggressive type of brain tumour.
“We believe that
the increase in the number of patients may further validate the study,
and accelerate the path to data analysis,” said resident and CEO Manish
“The additional patients could also provide for a more robust and meaningful trial.”
are currently 231 patients enrolled in the study and more than 105
patients have either been treated or are scheduled to be over the next
few weeks. ImmunoCellular said it expects to complete the expanded
enrollment within the next 60 days.
The phase 2b double-blind,
placebo-controlled, randomized study is designed to evaluate the safety
and efficacy of the vaccine in patients with newly diagnosed GBM, a type
of brain cancer.
The expanded study is expected to 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.
the phase 1 clinical study of ICT-107 in GBM, the company noted that 16
newly diagnosed patients who received the vaccine in addition to
standard of care treatment of surgery, radiation and chemotherapy
demonstrated a two-year overall survival of 80 per cent and a three-year
overall survival of 55 per cent.
ImmunoCellular said that
updated data from the 16 patients in the phase 1 trial shows that
patients treated with ICT-107 reported overall survival of 50 per cent
after four years and 38 per cent of the trial patients are progression
free for 48 to 66 months.
“This compares very favorably to historic mean overall survival of
12.1 per cent after four years and 5.6 per cent progression free after
48 months with standard of care alone,” said the company.
It has initiated the trial in 25 sites, with patients enrolled in
medical centers like Mass General Cancer Center and the Dana Farber
ImmunoCellular is a Los Angeles-based clinical-stage company that is
developing immune-based therapies for the treatment of brain and other
The company’s lead product candidate is ICT-107, a
dendritic cell-based vaccine. Rather than simply targeting a single
tumor-specific antigen, the company's vaccine pursues multiple different
antigens found on cancer stem cells (CSCs).
Cancer stem cells are thought to be the originators of common tumor
cells. It is believed that destroying the CSCs will allow for longer
survival without relapse.