This clinical trial is designed to evaluate the safety and efficacy of ImmunoCellular's lead product candidate ICT-107, a patient-derived dendritic cell-based immunotherapy.
Anthony Gringeri, ImmunoCellular's Senior Vice President, Strategic Resources, commented, "We chose to partner with Cryoport for the registrational trial of ICT-107 because of their cold chain logistics expertise and proven ability to manage the challenges of transporting valuable, temperature-sensitive cryogenically frozen materials. Of additional significance is their specialized logistics operating platform for the timely and secure delivery of our immunotherapy to the large number of patients participating in our trial in the US, Canada and Europe."
ImmunoCellular's ICT-107 immunotherapy targets six different antigens, peptides that are tumor markers, associated with the aggressive cancer of the brain, glioblastoma. More than 400 patients with newly diagnosed glioblastoma will be enrolled across 120 sites to participate in the trial. The regimen in the Phase III trial is standard of care plus or minus ICT-107 immunotherapy. The regimen includes induction immunotherapy (4 doses in month 1) and maintenance (monthly doses through month 12 or progression).
Jerrell Shelton, Chief Executive Officer of Cryoport, Inc. commented, "Our agreement with ImmunoCellular Therapeutics marks a substantial milestone in Cryoport's history as it is one of the largest volume trials we have supported. We are delighted that our advanced cryogenic logistics solutions will play an integral role in the execution of this Phase III trial. We will ensure the successful delivery of ImmunoCellular's immune-based therapy to the 120 sites located in North America and Europe as we employ our technology based solutions. With this partnership, Cryoport now supports 64 clinical trials worldwide, ten of which are Phase III trials."
"The biotech industry continues to develop advanced biologic and immunotherapeutic solutions that are sensitive to their environment and require the maintaining of specific temperatures during storage and transit. As these therapies have moved from the development stage and into the clinic, the need for a safe, effective and consistent way to transport them has become clearer to everyone in the industry. We are confident that our track record makes Cryoport an indispensable resource for the advancement of the biologics market," concluded Mr. Shelton.