ImmunoCellular's lead drug is a cancer immunotherapy, ICT-107, under development as a treatment for glioblastoma multiformae, a form of brain tumor. Updated data from a phase I trial in 16 patients treated with ICT-107 showed a four-year survival rate of 50%, with 38% of patients reporting no tumor growth for 48-66 months. These new data were reported at the ASCO meeting last week.
The company claims these results compare very favorable to an "historic" mean overall survival of 12% after four years.
Be skeptical when a company compares data from a single-arm trial to "historic" results, particularly a single-arm trial of only 16 patients, all enrolled by the same investigator at a single hospital.
Unless a clinical trial directly compares an experimental therapy to a placebo or some other control -- something ImmunoCellular did not do in the phase I study of ICT-107 -- an observation of a survival benefit cannot be determined. The ICT-107 data look promising but that may disappear completely when larger, randomized trials are conducted.ImmunoCellular is running a larger, randomized phase II study of ICT-107 versus a placebo in glioblastoma multiformae patients. Interim results from this study are expected in the first quarter 2013. ImmunoCellular's fully diluted share count (including options and warrants) is approximately 55 million. At $3.70 per share, the company's market value of $204 million isn't cheap. --Written by Adam Feuerstein in Boston.
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