Wednesday, 9 May 2012

ImmunoCellular expects to complete phase II cancer vaccine enrollment in Q2

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 2012.
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 data."
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 cancers.
The company’s shares were up 2.19 percent on Wednesday afternoon, trading at $2.33.

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