Glioblastoma vaccine enters phase II
pharmafile | February 24, 2011 | News story | Research and Development |Â Â Cancer, GBM, ImmunoCellular Therapeutics, oncologyÂ
The first patient has been enrolled in a phase II trial of ICT-107, a cancer vaccine candidate for the treatment of glioblastoma multiforme (GBM).
US biotech company ImmunoCellular Therapeutics hopes the cutting-edge treatment will help patients with GBM, an aggressive and hard to treat cancer of the brain.
ICT-107 is a dendritic cell based cancer vaccine and the trial is being conducted at the New Jersey Neuroscience Institute at JFK Medical Center.
The drug works by activating a patient’s immune system against specific tumour-associated antigens. This is accomplished by extracting dendritic cells from a patient, loading them with the antigens, and reintroducing them to the patient’s body to trigger an immune response. The first ever therapeutic vaccine to use this technique, Dendreon’s Provenge, was approved in the US in April 2010.
“The enrollment of the first patient in the phase II trial of ICT-107 represents a hopeful step towards the development of a more effective treatment for an extremely aggressive type of brain tumour, and may ultimately result in the drastic decrease of associated rates of mortality,” said Dr. Joseph C. Landolfi, Director of Neuro-Oncology at the NJ Neuroscience Institute.
The double-blind, placebo-controlled, 2:1 randomised phase II study is designed to evaluate the safety and efficacy of ICT-107 in patients with newly diagnosed GBM. The study will enroll approximately 100 patients and will be conducted at an estimated 15 clinical trial centres in the US in collaboration with leading experts and opinion leaders in neuro-oncology.
In the phase I clinical study of ICT-107 in GBM, newly diagnosed patients who received the vaccine in addition to the standard of care of surgery, radiation and chemotherapy demonstrated a one year overall survival of 100% and a two year survival of 80 percent. This compares favourably with historical 61.1% one-year and 26.5% two-year survival based on the standard of care alone. The median overall survival has not yet been reached at over 30 months analysis point, with 11 out of 16 patients alive (69% percent).
The 12-month disease-free survival from the time of surgery was 75% with ICT-107, compared with the historical control of 26.9%, and the 24 month disease-free survival with ICT-107 was 43.8%, compared with 10.7% historically. The median progression-free survival (PFS) of 16.9 months after surgery compared especially favorably with the historical median PFS of 6.9 months observed with the standard treatment. Six of the 16 patients (37%) who participated in the study continue to live with no disease progression with an average time of over 30 months. Safety data for ICT-107 also compared favourably to current treatments: no serious adverse events were reported and minor side effects included fatigue, skin rash and pruritis.
Andrew McConaghie
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