Across our three ascending-dose Phase 1 trials, Tocagen has treated 127 patients with recurrent high grade glioma, or HGG, with Toca 511 & Toca FC. In these trials, potential benefits were observed, including durable objective responses, extended overall survival and a favorable safety profile. The recommended dose for future trials was also identified. Based on these Phase 1 clinical trial results, a pivotal Phase 3 clinical trial for patients with first or second recurrent HGG undergoing resection is ongoing.
The U.S. Food and Drug Administration (FDA) granted Toca 511 & Toca FC Breakthrough Therapy Designation for the treatment of recurrent HGG and the European Medicines Agency (EMA) has granted Toca 511 PRIME (PRIority MEdicines) designation for the treatment of HGG. These designations are granted to new products that treat serious diseases or conditions and demonstrate the potential to address an unmet medical need.
Tocagen has also obtained a $2 million Orphan-Drug Grant to support the Toca 5 trial and received Orphan-Drug Designation for the treatment of malignant glioma. Orphan-Drug Designation is a designation for a product that treats a rare disease or condition and which, if the product receives the first FDA approval for that disease or condition, may result in a period of regulatory exclusivity, subject to some exceptions.