On June 15, 2015 ImmunoCellular Therapeutics reported the selection of PCT, LLC, a subsidiary of Caladrius Biosciences, Inc. ("Caladrius") (NASDAQ:CLBS), as the US manufacturer for ImmunoCellular’s ICT-107 phase 3 registrational clinical program in newly diagnosed glioblastoma, anticipated to begin in the second half of 2015 (Press release, ImmunoCellular Therapeutics, JUN 15, 2015, View Source [SID:1234505433]). Schedule your 30 min Free 1stOncology Demo! Under the terms of the multi-year agreement, PCT will provide current good manufacturing practice (cGMP) services for the manufacture of clinical supplies of ICT-107, a dendritic cell-based immunotherapy targeting six tumor-associated antigens. PCT, which was previously engaged by ImmunoCellular to manufacture clinical supplies of ICT-107 and the Company’s other cancer immunotherapy clinical programs, is also working with ImmunoCellular’s European contract manufacturer, PharmaCell B.V., to perform a technology transfer process to harmonize the EU and US methods of production of ICT-107 for the planned phase 3 registration trial. PCT’s facilities are registered with the FDA as human cells, tissues, and cellular and tissue-based products (HCT/Ps) facilities, and maintain GMP-compliant quality systems.
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"Selecting our US manufacturer for the ICT-107 phase 3 trial is an important step toward initiation of our registration program," said Andrew Gengos, ImmunoCellular Chief Executive Officer. "We have been pleased with PCT’s ability to provide high quality, cost-effective and consistent manufacturing, and have confidence in their ability to support our phase 3 trial. Over the coming weeks, we look forward to announcing additional key milestones toward initiating the phase 3 trial, which have the potential to be major value-creating events for our Company. We expect to be in position to begin patient enrollment in the late third quarter or early fourth quarter of this year."
"We are extremely pleased that the leadership team at ImmunoCellular has chosen to develop a long-term relationship partnership with PCT in order to maintain the cell therapy manufacturing reliability, quality, and cost efficiencies they have come to expect," said Dr. Robert A. Preti, President of PCT, and Chief Technology Officer of Caladrius. "We feel our clients significantly reduce their clinical development risk by manufacturing with PCT and leveraging our Innovation and Quality infrastructure."