Geron will receive a $25 million loan from the California Institute for Regenerative Medicine (CIRM) to support clinical development of it's Phase I human embryonic stem cell (hESC)-based treatment for spinal cord injury (SCI), GRNOPC1. The therapy contains hESC-derived oligodendrocyte progenitor cells that have demonstrated remyelinating, nerve growth stimulating, and angiogenic properties, which have led to restoration of function in animal models of acute SCI.
“The successful performance of the proposed project would enable significant additional jobs creation in preparation for pivotal trials and product registration,” Geron said in an abstract of the project to CIRM. The company employs 182 full-time staffers at its Menlo Park, CA, headquarters.
CIRM's Targeted Clinical Development Award will be structured as a product-backed loan, with Geron’s obligation for repayment being contingent on commercial success of GRNOPC1 for SCI. The award is expected to support funding of clinical trial costs, nonclinical studies, analytical development, and the manufacture of cells to be used in the clinical trials.
Geron's Phase I trial involves patients with neurologically complete American Spinal Injury Association (ASIA) Impairment Scale grade-A thoracic spinal cord injuries. In this first cohort of patients, a dose of 2 million cells is being administered to assess safety. Once the cell therapy has been found safe, clinical testing will be expanded to tetraplegic patients (complete cervical injuries) and to patients with incomplete thoracic injuries.