ImmunoCellular Therapeutics (OTC:IMUC) said Wednesday that it has enrolled 189 patients for its phase II clinical trial of the company’s cell-based cancer vaccine candidate.
The company, focused on the development of immune-based cancer
therapies, provided an update on clinical trial site activity and
patient enrollment for its dendritic cell based cancer vaccine candidate
that targets multiple tumor antigens for the treatment of glioblastoma
multiforme (GBM), an aggresive type of brain cancer.
ImmunoCellular said it has initiated the trial in 25 sites, with
patients enrolled in medical centers such as Mass General Cancer Center
and the Dana Farber Cancer Institute.
The company expects to enroll approximately 200 or more patients in
the trial, to treat 102 patients with HLA-A1/A2 immunological subtypes,
and enrollment is expected to be completed by the second quarter of
The phase II trial of the cancer vaccine, ICT-107, is a double-blind,
placebo-controlled, 2:1 randomized study designed to evaluate the
safety and efficacy of the vaccine in patients with newly diagnosed GBM.
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.
The company noted that the phase II study is enrolling patients at
medical institutions in collaboration with experts and opinion leaders
in neuro-oncology at those sites.
"We are excited with the enrollment progress made in the Phase II
clinical trial of ICT-107," said president and CEO Manish Singh, Ph.D.
"We appreciate the continued support from leading medical centers and
oncologists as we move our focus from enrollment to obtaining patient
In the phase I clinical study of ICT-107, ImmunoCellular reported
that 16 newly diagnosed patients who received the vaccine in addition to
standard of care, showed two year overall survival of 80 percent and a
three year survival of 55 percent.
The company said these figures "compare favorably" to the 26 percent
two-year, and 16 percent three-year survival, based on the historical
standard of care treatment alone.
ImmunoCellular reported that the median overall survival was 38.4
months compared to 14.6 months for the historical standard of care.
The study’s median progression free survival (PFS) of 16.9 months was also higher than the historic median PFS of 6.9 months.
ImmunoCellular said that six out of the 16 newly diagnosed patients
who received ICT-107 continue to show no tumor recurrence at the last
analysis, with three of these patients remaining disease-free for more
than four years, while the other three patients have gone more than
three years disease-free.
There have been no serious adverse treatment-related symptoms observed in any of the patients.
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 shares were up 2.19 percent on Wednesday afternoon, trading at $2.33.