LOS ANGELES, May 6, 2016 /PRNewswire/ -- ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) today announced that the Company has received approval from regulatory authorities in Canada, the United Kingdom and the Netherlands to initiate the ICT-107 Phase 3 registration trial in patients with newly diagnosed glioblastoma. Patient screening is anticipated to commence shortly and the first clinical supplies could be manufactured for qualifying patients in Canada and Europe in the third quarter of 2016. The Company also is near to completing interactions with regulatory authorities in six other European countries and currently expects approval of those clinical trial applications in June 2016, with patient screening to begin in the third quarter of 2016.
"We are very pleased with the progress of our ICT-107 registrational trial in the US, Canada and Europe," said Andrew Gengos, ImmunoCellular Chief Executive Officer. "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 are deeply appreciative of the support and enthusiasm expressed by our European colleagues, and their recognition of the importance and potential promise of the ICT-107 program, in light of the high unmet need and lack of new treatments for patients with brain
cancer. 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."
About ImmunoCellular Therapeutics, Ltd.
ImmunoCellular Therapeutics, Ltd. is a Los Angeles-based clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers. The phase 3 registrational trial of lead product candidate, ICT-107, a patient-specific, dendritic cell-based immunotherapy targeting multiple tumor-associated antigens on glioblastoma stem cells, is open for patient screening. ImmunoCellular's pipeline also includes: ICT-121, a patient-specific, dendritic cell-based immunotherapy targeting the CD133 antigen on stem cells in recurrent glioblastoma; ICT-140, a patient-specific, dendritic cell-based immunotherapy targeting antigens on ovarian cancer stem cells; and the Stem-to-T-cell research program which
engineers the patient's hematopoietic stem cells to generate antigen-specific cancer-killing T cells. To learn more about ImmunoCellular, please visit www.imuc.com.
Forward-Looking Statements for ImmunoCellular Therapeutics
This press release contains certain forward-looking statements, including statements regarding the development and commercialization of ICT-107, progress of a Phase 3 study of ICT-107, including patient screening and enrollment, and our ability to achieve our other clinical, operational and financial goals. In some cases, you can identify these statements by forward-looking words such as "believe," "may," "will," "anticipate," "could," "would," "plan," "expect" or the negative or plural of these words or similar expressions. These statements are based on ImmunoCellular's current expectations and involve significant risks and uncertainties, including those described under the heading "Risk Factors" in ImmunoCellular's most recently filed quarterly report on Form 10-Q and annual report on
Form 10-K. Except as required by law, ImmunoCellular undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
ImmunoCellular Therapeutics, Ltd.
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