Accurexa, UCSF Gain FDA Pre-IND Guidance

Accurexa and University of California, San Francisco have received a written response from FDA providing guidance on non-clinical activities that are necessary to enable the filing of a future IND for a combined stem cell/gene transfer therapeutic (CNS10-NPC GDNF) for treating Parkinson’s Disease using Accurexa's BranchPoint delivery device. CNS10-NPC are human fetal neural stem cells that express Glial-Derived Neurotrophic Factor (GDNF) and are expected to be supplied by the Cedars-Sinai Regenerative Medicine Institute. “Although controversy surrounds the clinical use of GDNF, its neuroprotective and regenerative effects in animal models of Parkinson’s Disease have been independently corroborated by several laboratories,” Accurexa says . “Like other trophic factors, GDNF requires intracerebral site-specific delivery to be effective and decrease the risk of side effects.”