ImmunoCellular wins regulatory approval to start ICT-107 phase 3 trial in newly diagnosed glioblastoma

The company plans to start patient screening shortly and the initial clinical supplies could be produced for qualifying patients in Canada and Europe in the third quarter of this year.

In addition, ImmunoCellular is also completing interactions with regulatory authorities in six other European countries.

The company expects approval of those clinical trial applications next month, with patient screening to start in the third quarter.

ImmunoCellular Therapeutics CEO Andrew Gengos said: "We recently held our European investigator kick off meeting in Barcelona and had 100% attendance of investigators and coordinators from the 48 European clinical sites planning to participate in the trial.

"We think that the ICT-107 program could be the best designed registrational program underway in newly diagnosed glioblastoma and look forward to announcing the treatment of our first patient."

The primary endpoint in the trial is overall survival. Secondary endpoints include progression-free survival and safety, as well as overall survival in the two pre-specified MGMT subgroups.

ICT-107 is an autologous dendritic cell immunotherapeutic that targets six different antigens associated with glioblastoma, the most common and lethal form of brain cancer.

Four of the tumor-associated antigens are highly expressed on cancer stem cells. ICT-107 is designed for use after surgical tumor resection of newly diagnosed glioblastoma in combination with standard treatment of radiation and chemotherapy.

ICT-107 has been granted orphan drug designation in the US and Europe.