MEMPHIS and MUNICH, June 25, 2012 –MRI Interventions, Inc. (OTCBB:MRIC) 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 U.S. 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.
“We are enthusiastic about the potential of combining our new Toca 511 investigational therapy with the next generation brain delivery platform represented by the ClearPoint system,” said Harry Gruber, M.D., CEO of Tocagen.
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.
“Excitement among researchers and drug companies to explore use of the ClearPoint system for direct drug delivery began to build last year, on the heels of two research publications from UCSF,” noted Kimble Jenkins, CEO of MRI Interventions. “We are pleased to announce today our first drug development alliance that brings together our ClearPoint platform with a promising experimental brain cancer therapy from Tocagen.”
Joseph Doyle, CFO of Brainlab added, “By offering a platform for delivering therapeutic agents direct to the central nervous system, we hope to make promising therapies more accessible to patients.”
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 US.
Founded in 1998, MRI Interventions (OTCBB:MRIC) is a publicly traded company creating innovative platforms for performing the next generation of minimally invasive surgical procedures in the brain and heart. Utilizing a hospital's existing MRI suite, the company's FDA-cleared ClearPoint® system is designed to enable a range of minimally invasive procedures in the brain. MRI Interventions has a co-development and co-distribution agreement with Brainlab, a leader in software-driven medical technology, relating to the ClearPoint system. In partnership with Siemens Healthcare, MRI Interventions is developing the ClearTrace™ system to enable MRI-guided catheter ablations to treat cardiac arrhythmias, including atrial fibrillation. Building on the imaging power of MRI, the company's interventional platforms strive to improve patient care while reducing procedure costs and times. MRI Interventions is also working with Boston Scientific Corporation to incorporate its MRI-safety technologies into Boston Scientific's implantable leads for cardiac and neurological applications. For more information, please visit www.MRIinterventions.com.
Founded in 1989, the privately held Brainlab group has more than 5,000 systems installed in about 80 countries. Based in Munich, Germany, Brainlab employs 1,070 people in 17 offices worldwide. Brainlab develops, manufactures and markets software-driven medical technology that supports targeted, less-invasive treatment. Core products are image-guided systems and software that provide real-time information used for surgical navigation and radiosurgical planning and delivery. Brainlab technology drives collaboration between hospitals and clinicians from a wide variety of subspecialties—from neurosurgery and oncology to orthopedics, ENT, CMF and spine and trauma. This integration delivers better access to improved and more efficient treatment. To learn more, visit www.brainlab.com.
Certain matters in this press release may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements often can be identified by words such as "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would," or the negative of these words or other words of similar meaning. Forward-looking statements by their nature address matters that, to different degrees, are uncertain and involve risk. Uncertainties and risks may cause MRI Interventions' actual results and the timing of events to differ materially from those expressed in or implied by MRI Interventions' forward-looking statements. For MRI Interventions, particular uncertainties and risks include, among others: demand and market acceptance of its products; its ability to successfully complete the development of, and to obtain regulatory clearance or approval for, future products, including its current product candidates; availability of third party reimbursement; the sufficiency of its cash resources to maintain planned commercialization efforts and research and development programs; future actions of the FDA or any other regulatory body that could impact product development, manufacturing or sale; its ability to protect and enforce its intellectual property rights; its dependence on collaboration partners; the retention of its sales representatives and independent distributor; the impact of competitive products and pricing; and the impact of the commercial and credit environment on it and its customers and suppliers. More detailed information on these and additional factors that could affect MRI Interventions' actual results are described in MRI Interventions' filings with the Securities and Exchange Commission, including, without limitation, the quarterly report on Form 10-Q for the quarterly period ended March 31, 2012. Except as required by law, MRI Interventions undertakes no obligation to publicly update or revise any forward-looking statements contained in this press release to reflect any change in MRI Interventions' expectations or any change in events, conditions or circumstances on which any such statements are based.
Source: MRI Interventions, Inc., Brainlab AG