Six Presentations on Tocagen's Toca 511 to be Given at the Society of Neuro-Oncology Annual Meeting

SAN DIEGO, Nov. 22, 2013 /PRNewswire/ -- Tocagen Inc. today announced that six presentations on Toca 511 will be given at the Society of Neuro-Oncology (SNO) Annual Meeting, including interim clinical data from two ongoing Phase I investigational studies, which show that, to date, Toca 511 administration followed by oral courses of Toca FC is safe and well tolerated, and demonstrated antitumor activity in some patients with high grade glioma (HGG). HGG includes glioblastoma multiforme (GBM), the most common and aggressive form of primary brain cancer. Toca 511 is a retroviral replicating vector that carries a gene for an enzyme that converts orally delivered Toca FC (extended-release 5-FC) into 5-FU, a potent anti-cancer agent.

The data will be presented at the 4th Quadrennial Meeting of the World Federation of Neuro-Oncology held in conjunction with the 18th Annual Meeting of the Society for Neuro-Oncology in San Francisco. Timothy Cloughesy, M.D., director of the Neuro-Oncology Program at the University California, Los Angeles Jonsson Cancer Center and a principal investigator for the Toca 511 resection study, will make an oral presentation titled "Evidence supporting mechanism of action and drug activity in Phase I trial of patients with recurrent high grade glioma administered Toca 511 at the time of surgical resection followed by Toca FC." This presentation will be given on Sunday, Nov. 24, during the Biologic/Immunologic Therapies session from 10:20 a.m. to 12 p.m. PST.

Data from additional studies of Toca 511 will be presented at the conference in the following poster presentations:

• "A phase I trial of a retroviral replicating vector (Toca 511) in patients with recurrent high grade glioma demonstrates importance of real-time MRI-guided delivery for evaluation of safety and efficacy,"  Friday Nov. 22, 7 to 9 p.m. PST
• "Intravenous administration of Toca 511 results in uniform distribution of viral spread within the tumor and increased survival in a synergistic, orthotopic mouse glioma model," Saturday Nov. 23, 5 to 7 p.m. PST
• "Toca 511 gene transfer in combination with temozolomide appears safe and demonstrates synergistic therapeutic efficacy in mouse glioblastoma model," Saturday Nov. 23, 5 to 7 p.m. PST
• "Prodrug activator gene therapy with a non-lytic retroviral replicating vector (Toca 511) radiosensitizes glioma cells after intracellular generation of 5-fluorouracil," Saturday, Nov. 23, 5 to 7 p.m. PST
• "Enhancing retroviral replicating vector-mediated prodrug activator gene therapy with engineered mesenchymal stem cells in animal models of glioma," Saturday Nov. 23, 5 to 7 p.m. PST

About Toca 511 & Toca FC

The combination of Toca 511 (vocimagene amiretrorepvec) for injection and Toca FC (flucytosine) extended-release tablets, is being investigated in Phase I studies at leading centers across the US in clinical studies in patients with recurrent high grade glioma, including GBM. Toca 511 is a retroviral replicating vector (RRV) that is designed to deliver a prodrug activator gene called cytosine deaminase (CD) selectively to cancer cells. After allowing time for Toca 511 to spread through the tumor, those cancer cells expressing the CD gene can convert the antibiotic drug flucytosine into the anti-cancer drug 5-fluorouracil (5-FU). By producing 5-FU locally, this technology has the potential to produce much higher intratumoral concentrations of 5-FU than can be attained with systemic administration.  In these studies, patients receive a single administration of Toca 511 at the time of surgery (craniotomy or transcranial) followed by repeat cycles of oral Toca FC. To date, a total of 57 patients have received the combination therapy in the two studies.

About Tocagen

Tocagen Inc. is a privately funded, clinical stage biopharmaceutical company pursuing the discovery, development and commercialization of gene therapy products for the treatment of cancer. Tocagen is initially focusing on treatments for patients with advanced cancer for whom no adequate treatments currently exist. Toca 511 & Toca FC, the company's lead investigational combination product candidate, is being evaluated in two clinical trials in patients with recurrent high grade glioma, including GBM. Tocagen has received grant support from leading brain cancer foundations including, Accelerate Brain Cancer Cure (ABC2), National Brain Tumor Society (NBTS), American Brain Tumor Association (ABTA), Musella Foundation, and Voices Against Brain Cancer (VABC). For more information about Tocagen or Toca 511 please visit www.tocagen.com or www.clinicaltrials.gov.

SOURCE Tocagen Inc.