First Combination of ClearPoint® Neuro Intervention System within VISIUS® Surgical Theatre to Achieve Real-Time MRI-Guided Delivery of
Investigational Gene Therapy Drug Toca 511 Highlights Collaboration
among Three High-Tech Healthcare Companies to Deliver Novel Therapy
IRVINE, CA, May 30, 2013 /CNW/ - MRI Interventions, Inc. (OTCQB:MRIC)
and IMRIS Inc. (NASDAQ: IMRS; TSX: IM) ("IMRIS") today announced that a
surgical team at a leading U.S. neuroscience institution has delivered
the investigational gene therapy drug Toca 511 directly into a
glioblastoma brain tumor using real-time intraoperative MRI (iMRI)
guidance within an IMRIS VISIUS® Surgical Theatre. MRI Interventions' ClearPoint® Neuro Intervention System served as the navigation platform and the
ClearPoint SmartFlow® large-bore cannula as the vehicle for delivery of the therapeutic
The procedure performed in early May marks the first convergence of
these technologies - Toca 511, the VISIUS Surgical Theatre, and the
ClearPoint System - in a unique collaboration allowing surgeons to
visually monitor and confirm delivery of the desired amount of the
potentially cancer-fighting drug precisely to the target location in
the patient's brain within a state-of-the-art operating room designed
for patient safety and efficiency.
VISIUS Surgical Theatres feature a high-field iMRI that travels
on-demand between two operating rooms on ceiling rails for diagnostic
and surgical usage. The multi-disciplinary suite provides truly
intraoperative imaging as it does not require the patient to be moved
from the OR table for scanning during surgery, so optimal positioning
for neurosurgery is not compromised and typical clinical workflow is
The ClearPoint System is the only navigation platform designed to permit
real-time, direct visualization during minimally-invasive neurosurgical
procedures by utilizing the powerful imaging capabilities of MRI.
Surgeons use the ClearPoint System to plot a neurological target, plan
the optimal trajectory to the target, and monitor the placement of
surgical tools and devices in real time throughout the operation. The
ClearPoint System then provides immediate visual confirmation of the
results of a procedure.
The ClearPoint System also features the SmartFlow large-bore cannula for
drug delivery, which is designed to prevent reflux and leakage of a
therapeutic agent outside of the target area. The SmartFlow large-bore
cannula has demonstrated an ability to increase drug delivery rates by
up to three times the delivery rate allowed with the original SmartFlow
Using the VISIUS Surgical Theatre's iMR imaging in conjunction with the
ClearPoint System's guidance software and ClearPoint MR-compatible
components, neurosurgeons are able to visually differentiate tumor
tissue from healthy brain tissue, establish the target location for
delivery of the therapeutic agent, and visualize delivery of the
therapy in real time.
"We believe the key to drug delivery in the brain is the precise
delivery of the therapeutic agent with immediate visual confirmation of
results, to ensure that the full potential of the therapy is measured
without apprehension over whether the drug hit its target," said Kim
Jenkins, CEO of MRI Interventions. "With ClearPoint and real-time MR
imaging, the surgeon can know that the drug hit its target. We look
forward to continuing our work with Tocagen and IMRIS at select
clinical trial sites to develop and optimize the natural synergy of
IMRIS CEO David Graves said that these technologies working together
illustrate the benefits of providing imaging at the point of therapy
delivery. "This kind of therapy represents the future of neurosurgery
and it is enabled by the VISIUS Surgical Theatre platform where exact
targeting and delivery of focal therapies can be visualized as they
In addition to drug delivery, the combination of ClearPoint and VISIUS
technologies could offer significant intraoperative advantages in
neurosurgical applications including laser ablation therapy, deep brain
stimulation surgery, and brain biopsy.
About Toca 511
Tocagen Inc., the clinical trial sponsor, is developing the investigational drug
Toca 511 (vocimagene amiretrorepvec) in combination with Toca FC (an
investigational extended-release formulation of 5-FC) for the treatment
of recurrent high grade glioma, including glioblastoma multiforme (GBM,
Grade IV glioma), the most common and aggressive form of brain cancer.
Toca 511 is a retroviral replicating vector (RRV) encoding the genetic
instructions for the enzyme cytosine deaminase (CD). Toca 511 is
designed to selectively infect dividing cancer cells and spread through
the tumor after administration. Each patient then begins a course of
Toca FC. Within infected cells, the CD enzyme converts 5-FC to the
anti-cancer drug 5-FU. By producing 5-FU locally, this technology has
the potential to produce much higher concentrations of 5-FU in the
tumor than can be safely attained with systemic administration.
Tocagen is presently enrolling patients in its investigational Phase I
clinical trials. Currently, University of California, San Francisco;
University of California, San Diego; Cleveland Clinic Foundation; and
Henry Ford Hospital in Detroit are enrolling patients, and additional
sites are in the process of joining this study. For more information
about participating in this study, please submit an inquiry form to Tocagen.
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 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 candidate, is being evaluated
in clinical trials in patients with recurrent high grade glioma (such
as glioblastoma multiforme). Tocagen has received grant support from
leading brain cancer foundations including, Accelerate Brain Cancer
Cure (ABC2, the National Brain Tumor Society NBTS), the American Brain Tumor Association (ABTA), and the Musella Foundation. For more information about Tocagen or
Toca 511 please visit: www.tocagen.com.
IMRIS (NASDAQ: IMRS; TSX: IM) is a global leader in providing image
guided therapy solutions through its VISIUS Surgical Theatre - a
revolutionary, multifunctional surgical environment that provides
unmatched intraoperative vision to clinicians to assist in decision
making and enhance precision in treatment. The multi-room suites
incorporate diagnostic quality high-field MR, CT and angio modalities
accessed effortlessly in the operating room setting. VISIUS Surgical
Theatres serve the neurosurgical, cardiovascular and cerebrovascular
markets and have been selected by 54 leading medical institutions
around the world.
About the ClearPoint SmartFlow Cannula
The SmartFlow cannula is presently FDA-cleared for injection of
cytarabine, a chemotherapy drug, to the ventricles or removal of CSF
from the ventricles during intracranial procedures. Delivery of Toca
511 using the SmartFlow cannula is investigational.
About MRI Interventions, Inc.
Founded in 1998, MRI Interventions (OTCQB: 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 and CE-marked 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.
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. Particular
uncertainties and risks include, among others: demand and market
acceptance of our products; our ability to successfully expand our
sales and clinical support capabilities; our ability to successfully
complete the development of, and to obtain regulatory clearance or
approval for, future products, including our current product
candidates; availability of third party reimbursement; the sufficiency
of our 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; our ability to protect and enforce our
intellectual property rights; our dependence on collaboration partners;
the impact of competitive products and pricing; and the impact of the
commercial and credit environment on us and our 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, MRI Interventions' Quarterly Report on
Form 10-Q filed with the Securities and Exchange Commission on May 10,
2013. 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: IMRIS Inc.
For further information:
Tocagen Contact: Carin Canale
IMRIS contact information:
MRI Interventions, Inc. Contact Information:
MRI Interventions, Inc.
David Carlson, CFO, 901-522-9300