June 28, 2012 — MRI Interventions, Inc. and Brainlab AG today announced an alliance with Tocagen Inc. in the fight against the most aggressive form of brain cancer, recurrent high grade gliomas including glioblastoma multiforme (GBM). Under the arrangement, MRI Interventions’ clearpoint neuro intervention system will be utilized at selected sites in Tocagen’s ongoing investigational clinical trial for the delivery of Toca 511 into brain tumors under real-time magnetic resonance imaging (MRI) guidance. Patient recruitment is currently underway at one of several potential trial centers for this arm of this multicenter Phase I/II study.
Traditionally, delivery of drug therapies to brain tumors has been performed with neuro-navigation, a computer-assisted technology utilized by neurosurgeons that does not provide for direct visualization of drug delivery in real-time. The clearpoint system, which is in commercial use in the United States for a variety of minimally invasive neurosurgery procedures, is designed to allow real-time, direct visualization during neurosurgery. MRI Interventions and Brainlab have partnered to enable neurosurgeons to visualize local drug delivery to the brain and central nervous system using the clearpoint platform.
Tocagen is currently enrolling patients in its investigational clinical trial of Toca 511 in combination with Toca FC (flucytosine, extended-release) tablets. This multicenter, open-label trial is evaluating the safety and efficacy of Toca 511 injected into the brain tumor and followed by oral administration of Toca FC in patients with recurrent high-grade glioma.
Toca 511 is a retroviral replicating vector (RRV) that is designed to deliver a cytosine deaminase (CD) gene selectively to cancer cells. After Toca 511 spreads through the tumor, the CD gene in the cancer cells converts the prodrug, flucytosine, into the anti-cancer drug 5-fluorouracil (5-FU).
Under this new alliance, at selected trial centers, neurosurgeons participating in the Tocagen clinical trial plan to use the ClearPoint system to precisely place the drug delivery catheter in the brain tumor and then deliver Toca 511 directly into the tumor while observing this delivery real-time via MRI.
According to the National Brain Tumor Society, 620,000 people are currently living with a form of brain cancer. Each year 10,000 new glioblastoma multiformes (GBM, Grade IV gliomas), are diagnosed in the United States.