Results Continue to Show Safety and Promising Survival; Program to Advance into a Randomized, Controlled Trial
SAN DIEGO, – (April 10, 2014) — Tocagen Inc. today announced that updated interim clinical data from two ongoing investigational studies of Toca 511 in combination with Toca FC in 68 patients with recurrent high grade glioma were presented at the American Association of Neurological Surgeons (AANS) Annual Meeting in San Francisco. High grade gliomas include glioblastoma (GBM), the most common and aggressive form of primary brain cancer.
In patients treated to date, Toca 511 & Toca FC was shown to be safe and well-tolerated with minimal treatment-related toxicity. In both studies, landmark six and twelve month survival rates were higher than historical published data and the effect was consistent in both studies. In addition, during one of the presentations, a clinical case was described that supported the proposed dual mechanism of action involving direct cancer cell killing followed by immune activation selectively against residual tumor. The data were presented in sequential talks by Manish Aghi, M.D., associate professor of neurological surgery at the University of California, San Francisco, and Michael Vogelbaum, M.D., Ph.D., associate director of the brain tumor and neuro-oncology center at the Cleveland Clinic, both of whom are principal investigators of the Toca 511 & Toca FC studies.
“We are encouraged by the safety and tolerability profile from these trials and the preliminary survival data to date appear to surpass historical benchmarks,” said Dr. Vogelbaum. “There is an urgent need for effective treatment options for patients with recurrent glioblastoma so we look forward to completing the ongoing studies and help advance this promising therapy into a randomized controlled trial.”
Added Harry Gruber, M.D., CEO of Tocagen, “We are excited to advance our investigational treatment into the next stage of clinical development and are grateful for the strong support we have received from the brain cancer community.”
Toca 511 & Toca FC is an investigational gene therapy that is designed to selectively infect and kill cancer cells via a proposed dual mechanism of action: first, the Toca 511 virus selectively infects and mediates direct cancer cell killing via local production of 5-FU, a potent anticancer agent, and second, the immune system becomes activated selectively against the tumor resulting in long-term, systemic anticancer activity.
More information about the trials can be found at ClinicalTrials.gov using the identifiers NCT01470794 and NCT01156584. If interested in participating in a Tocagen trial, an inquiry can be submitted here.
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 clinical studies at leading centers across the United States in patients with recurrent high grade glioma, including glioblastoma (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 antifungal drug flucytosine into the anticancer drug 5-fluorouracil (5-FU). By producing 5-FU locally with CD, this technology has the potential to produce much higher intra-tumoral concentrations of 5-FU than can be currently attained with systemic administration. In addition to this initial, direct killing of cancer cells, data suggests a selective, local and systemic anticancer immune response without off-target toxicity, such as autoimmunity. The Toca 511 & Toca FC combination product is being investigated in three ascending dose trials in patients with recurrent high grade glioma.
About Tocagen Inc.
Tocagen Inc. is a privately funded, clinical stage biopharmaceutical company pursuing the discovery, development and commercialization of gene therapy products for the selective 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, is being evaluated in three clinical trials in patients with recurrent high grade glioma, including glioblastoma (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 using the identifier NCT01470794, NCT01156584 or NCT01985256.