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Tocagen's First-in-Human Clinical Trial of Toca 511 Enrolling Patients with High Grade Glioma
Date:6/7/2011

SAN DIEGO, June 7, 2011 /PRNewswire/ -- Tocagen Inc. today announced the company is enrolling patients with recurrent high grade glioma, such as those with glioblastoma multiforme (GBM, Grade 4), in its first-in-human clinical trial of Toca 511.

The multicenter, open-label study is evaluating the safety and tolerability of single ascending doses of Toca 511 administered intratumorally followed by cycles of the prodrug 5-fluorocytosine (5-FC) in patients who have failed prior surgery and chemoradiation. Patients will receive a single dose of Toca 511, a gene transfer viral vector that delivers a cytosine deaminase (CD) gene to tumor cells. After the vector is allowed to spread through the tumor for approximately 4 weeks, patients receive a six-day course of oral 5-FC. In the tumor cells expressing the CD gene, 5-FC is converted by the CD enzyme into the anti-cancer drug 5-fluorouracil (5-FU). Subsequently, patients receive additional cycles of oral 5-FC monthly for up to six months.

"There are limited treatment options available for patients with glioblastoma. It is therefore a priority to explore potential new therapies to treat this form of cancer," said 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 study. "Toca 511 is a novel approach that offers new hope to combating this deadly disease."

In studies performed in animal models of GBM, nearly all animals treated with Toca 511 followed by 5-FC lived for the duration of the study (six months), compared to less than two months for control (untreated) animals. Toca 511 spread through the brain tumors and, following 5-FC treatment, marked tumor regression occurred while healthy brain tissue was unharmed.

"Unlike conventional cancer treatments in which toxic side effects limit ho
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SOURCE Tocagen Inc.
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