MRI Interventions’ ClearPoint® Neuro Navigation System Utilized in Voyager Therapeutics’ VY-AADC01 Phase 1b Trial; Positive Interim Results Reported
Interim data from Cohorts 1 and 2 demonstrated that accurate MRI-guided delivery of escalating doses of VY-AADC01 were well tolerated and resulted in increased coverage of the putamen
ClearPoint Neuro Navigation System and SmartFlow® neuro ventricular cannula utilized in trial
IRVINE, Calif., Dec. 08, 2016 (GLOBE NEWSWIRE) -- MRI Interventions, Inc. (OTCQB:MRIC) today announced that its ClearPoint® Neuro Navigation System and SmartFlow® neuro ventricular cannula were used in the Voyager Therapeutics, Inc. Phase 1b Trial of VY-AADC01 for advanced Parkinson’s disease. The use of the ClearPoint System with real-time, intra-operative MRI-guided visualization and the advanced design of the SmartFlow® cannula contributed to the positive interim results.
“The VY-AADC01 trial shows the importance of using the ClearPoint Neuro Navigation System and our specially designed SmartFlow neuro ventricular cannula in these drug trials. Accurate placement of the vector is critical, and contributed to the positive results of this study," stated Frank Grillo, Chief Executive Officer for MRI Interventions. “Voyager reported that the use of real time, intra-operative MRI-guided delivery and increasing infusion volumes, utilizing the SmartFlow catheter, resulted in 21% coverage of the putamen with VY-AADC01 in Cohort 1 and 34% in Cohort 2. We believe that these results represent an important next step in the development of viable therapies for patients with Parkinson’s disease. We look forward to continued collaboration with Voyager on this promising therapy.”
In their discussion of the trial results to date, Voyager noted the following related to the ClearPoint System’s use for real time, MRI-guided navigation:
- The interim data from Cohorts 1 and 2 of this trial demonstrated that accurate MRI-guided delivery of escalating doses of VY-AADC01 were well tolerated and resulted in increased coverage of the putamen, increased AADC enzyme activity, enhanced response to levodopa, and dose-related, clinically meaningful improvements in various measures of patients’ motor function.
- The use of real-time, intra-operative MRI-guided delivery and increasing infusion volumes resulted in 21% coverage of the volume of the putamen with VY-AADC01 in Cohort 1 and 34% coverage in Cohort 2.
- In preparation for their randomized, placebo-controlled trial, Voyager plans to initiate a new trial that could enhance the efficiency of the surgical delivery and further increase both coverage and total vector dose. This trial will employ a posterior (i.e., back of the head), or occipital, trajectory which aligns the infusion of VY-AADC01 with the anatomical structure of the putamen. Voyager believes this will result in a higher total volume of coverage of the putamen and therefore a higher total dose (up to 9.4×1012 vg, representing a two-fold higher total dose than patients in Cohort 3) and may reduce surgical times.
“Real-time, MRI-guided infusions with the ClearPoint System and the SmartFlow neuro ventricular cannula were well tolerated and substantially improved our ability to tailor the infusions to fit the patients’ anatomy and accurately deliver vector to the putamen," said Paul Larson, M.D, Professor and Vice Chair of Clinical Neurological Surgery, University of California San Francisco, and investigator in the trial. “We were able to validate the increased surgical coverage via PET data, and our experience with the ClearPoint System in this trial and in other applications makes us confident that we can accurately deliver this therapy directly to the putamen.”
About MRI Interventions, Inc.
Building on the imaging power of MRI, MRI Interventions is creating innovative platforms for performing the next generation of minimally invasive surgical procedures in the brain. The ClearPoint System, which has received 510(k) clearance and is CE marked, utilizes a hospital’s existing diagnostic or intraoperative MRI suite to enable a range of minimally invasive procedures in the brain. For more information, please visit www.mriinterventions.com.
About Voyager Therapeutics
Voyager Therapeutics is a clinical-stage gene therapy company developing life-changing treatments for severe diseases of the CNS. Voyager is committed to advancing the field of adeno-associated virus (AAV) gene therapy through innovation and investment in vector engineering and optimization, manufacturing and dosing and delivery techniques. The Company’s pipeline focuses on severe CNS diseases in need of effective new therapies, including advanced Parkinson’s disease, a monogenic form of ALS, Friedreich’s ataxia, Huntington’s disease, frontotemporal dementia, Alzheimer’s disease and severe, chronic pain. Voyager has broad strategic collaborations with Sanofi Genzyme, the specialty care global business unit of Sanofi, and the University of Massachusetts Medical School. Founded by scientific and clinical leaders in the fields of AAV gene therapy, expressed RNA interference and neuroscience, Voyager Therapeutics is headquartered in Cambridge, Massachusetts. For more information, please visit www.voyagertherapeutics.com. Follow Voyager on LinkedIn.
Forward-Looking Statements
Statements herein concerning MRI Interventions, Inc. (the “Company”) plans, growth and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding the Company's future events, developments and future performance, as well as management's expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. Uncertainties and risks may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: the Company’s ability to obtain additional financing; estimates regarding the sufficiency of the Company’s cash resources; future revenues from sales of the Company’s ClearPoint system products; and the Company’s ability to market, commercialize and achieve broader market acceptance for the Company’s ClearPoint system products. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, both of which have been filed with the Securities and Exchange Commission.
Contact: Wendelin Maners, VP, Marketing MRI Interventions, Inc. 949-900-6833
Released December 8, 2016