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Friday, 7 September 2012
ImmunoCellular expects phase 2 analysis for brain cancer vaccine by year-end 2012
Biotech company ImmunoCellular Therapeutics (OTCBB: IMUC) said Wednesday that its phase 2 study for its potential hugely promising brain cancer vaccine is well underway, with trial enrollment expected by the second quarter of next year.
The Los Angeles-based company's cancer vaccine, named ICT-107, is designed to treat glioblastoma multiforme, an aggressive type of brain tumour.
The vaccine uses cancer stem cells to target multiple tumour-associated antigens, which generate an antibody response from the body's own immune system.
In other words, white blood cells are primed in the lab to attach to markers present in brain tumours, and these cells are then injected back into the body, where they travel to the brain and attack tumour cells.
To date, the company has initiated the phase 2 trial in 12 centres, with plans to increase the overall number of sites to 20 or more. So far, ImmunoCellular has received approval from the Institutional Review Board for a total of 18 trial sites.
The trial is expected to enroll between 150 to 160 newly diagnosed patients to treat a total of 102 patients, with 36 subjects enrolled already.
An interim analysis from the double-blind, placebo-controlled study, which will measure the safety and efficacy of the vaccine, is anticipated by the end of 2012, the company said.
"We are pleased with the progress we have made in our Phase II trial for the treatment of glioblastoma multiforme, said president and CEO, Manish Singh, Ph.D.
"We are encouraged by the strong interest we have received from the medical community, and the role that leading oncologists are playing in supporting our efforts to enroll patients."
Indeed, the vaccine has loads of potential for the patient population. In the phase one trial, 80% of 16 patients showed a two-year overall survival rate, while 44% also showed a progression-free survival rate. Even more, six of the 16 clinical patients had no tumor recurrence, with three remaining disease-free for almost four years, while the other three had gone more than two and a half years without cancer.
The vaccine was given in addition to standard of care therapy, including surgery radiation and chemotherapy.
No treatment-related serious adverse events were observed to date, the company said.