LOS ANGELES, July 25, 2016 /PRNewswire/ -- ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) today reported progress in its two lead cancer immunotherapy clinical programs: the phase 3 registrational trial of ICT-107 for newly diagnosed glioblastoma and the phase 1 trial of ICT-121 for recurrent glioblastoma.
In the ICT-107 phase 3 registrational trial, as of July 21, 2016, 109 patients have been screened in the US and Canada, with plans to randomize qualifying patients once they have completed standard of care and are re-screened (patients randomized in the trial are treated approximately 90 days following initial screening). In addition, clinical supplies (ICT-107 and placebo) for 12 patients have been manufactured. ImmunoCellular also reported that 56 clinical sites in the US and two sites in Canada have been activated, representing almost half the total number of the planned 120 sites for the trial.
ImmunoCellular has made progress toward initiating patient recruitment in Europe. The first clinical sites in Europe are anticipated to be activated in the third quarter of this year, and regulatory approval to begin the trial has now been received in the UK, the Netherlands and Spain. ImmunoCellular anticipates receiving regulatory approvals from all eight European countries participating in the trial in the third quarter of this year. In addition, ImmunoCellular's European manufacturer, PharmaCell B.V., has notified it that their process is now qualified to manufacture ICT-107 under Good Manufacturing Practices (cGMP).
As previously disclosed, in September of 2015, The California Institute of Regenerative Medicine (CIRM) awarded ImmunoCellular up to $19.9 million toward financing the ICT-107 phase 3 trial. This award is distributed to ImmunoCellular in milestone payments that are primarily dependent on patient enrollment and randomization. In June 2016, ImmunoCellular amended the terms of its award from CIRM to (i) increase the project initial payment by $1.5 million, and (ii) reduce the potential future milestone payments by a corresponding $1.5 million. The potential total amount of the award from CIRM remains at $19.9 million, inclusive of amounts received to date. On July 18, 2016, ImmunoCellular received the $1.5 million payment from CIRM related to the increase in the project initial payment. To date, ImmunoCellular has received $5.5 million from CIRM.
ImmunoCellular also reports that the phase 1 open-label trial of ICT-121 in patients with recurrent glioblastoma has completed enrollment, reaching the target of 20 patients. The trial is being conducted at six sites in the US and preliminary results are expected within the next 12 months.
"I am pleased with the progress ImmunoCellular has made in implementing our ICT-107 and ICT-121 clinical programs," said Andrew Gengos, ImmunoCellular Chief Executive Officer. "We continue to work diligently to advance these programs, as glioblastoma remains a high unmet medical need for which new treatments are needed. We appreciate the interest in our programs from the oncology community and our collaborators."
For patients, families and physicians seeking additional information about the ICT-107 phase 3 trial, please consult www.clinicaltrials.gov.
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, has been initiated. ImmunoCellular's pipeline also includes: ICT-121, a patient-specific, dendritic cell-based immunotherapy targeting the CD133 antigen on cancer 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 ImmunoCellular's intentions or current expectation concerning, among other things, timing for enrollment of patients, the activation of clinical sites, amount of clinical funding and the receipt of regulatory approvals to begin trials in Europe for its phase 3 registrational trial of ICT-107 for newly diagnosed glioblastoma, timing for preliminary results from the phase 1 trial of ICT-121 in patents with recurrent glioblastoma and the potential for eventual regulatory approval, commercialization and launch of ImmunoCellular's product candidates. Forward-looking statements are not guarantees of future performance and are subject to a number of risks and uncertainties, including the availability of resources to develop ImmunoCellular's product candidates, the uncertain timing of completion and success of clinical trials, the risk that ICT-107 can be further successfully developed or commercialized, the timing for completion of the phase 3 studies, whether the results will support registration filing with the FDA or EMA and the whether ImmunoCellular has sufficient resources to complete the phase 3 trial and if successful, file an NDA. Additional risks and uncertainties are described 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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