Tocagen continues progress with Phase I studies in patients with Recurrent, High Grade Glioma (HGG)
Two years after the National Brain Tumor Society presented an Innovation Research Grant to Tocagen Inc., Tocagen’s research team reported good progress with their innovative therapeutic approach to the treatment of brain cancer at their 2012 annual meeting. At the time of writing, Tocagen has now enrolled forty four patients in their Phase I dose escalation clinical trials with their investigational therapy, referred to as "Toca 511 & Toca FC".
To date, the therapy is well tolerated by patients and the clinical investigators have observed some early evidence of drug activity. “The speed of Tocagen’s progress and some of the early results from their clinical trials is encouraging,” commented N. Paul TonThat, Executive Director, NBTS, “our grant award to Tocagen exemplifies NBTS’s fierce commitment to drive research toward new therapies and improve the lives of those affected by brain tumors”.
Tocagen is currently running two studies in patients with recurrent high grade glioma. Both studies have broad entry criteria so that a large range of patients may be eligible to participate.
In Tocagen’s first clinical trial, Toca 511 is now co-injected with a gadolinium based contrast agent using a new method of intratumoral administration utilizing Real-Time Magnetic Resonance Imaging (RT-MRI) guidance. This procedure allows more precise delivery of Toca 511 into the tumor. This investigational study is actively enrolling patients at UC San Francisco, UC San Diego, Henry Ford Health System in Detroit, and the Cleveland Clinic Foundation. Additional sites, including, Ohio State University, UC Los Angeles, and the City of Hope in Duarte are in the process of being able to participate in this study. For more information on the clinicaltrials.gov website about this study, click here.
In Tocagen’s second clinical trial, Toca 511 is injected into the walls of the resection cavity immediately after the surgeon has removed as much of the recurrent tumor as possible. This investigational study is actively enrolling patients at UC Los Angeles, Cleveland Clinic Foundation, Ohio State University, Henry Ford Health System in Detroit, Swedish Neuroscience Institute in Seattle, and JFK Medical Center in New Jersey. For more information on the clinicaltrials.gov website about this study, click here.
What is Toca 511 & Toca FC and how is it designed to work?
Toca 511 is an investigational biologic drug that is designed to selectively deliver to cancer cells the genetic instructions to produce the cytosine deaminase (CD) enzyme. Toca 511 is administered by injection and after allowing time for Toca 511 to spread through the tumor, each patient begins a course of an extended-release oral tablet containing 5-FC, a well-tolerated investigational formulation called Toca FC. The CD enzyme converts the antifungal 5-FC into the potent anti-cancer drug 5-FU, leading to cancer cell death. This approach is designed to achieve a higher local concentrations of the anti-cancer drug 5-FU and its active metabolites in the brain cancer cells than would be otherwise attainable with systemically administered 5-FU. Please visit www.tocagen.com for more information.