NeoVista Epi-Retinal Strontium 90 Treatment for AMD: Update 4
To bring you up-to-date, I began following NeoVista in February 2007, writing an initial piece describing the procedure and initial clinical results. I also asked a series of questions of management and printed their responses. That first piece was:
NeoVista Epi-Retinal Strontium 90 Treatment for Wet AMD
In July 2007, the company announced the initiation of the CABERNET clinical study, and I posted an update, including more questions about the study to management. This piece was:
NeoVista Epi-Retinal Strontium 90 Treatment for AMD Update
NeoVista Epi-Retinal Strontium 90 Treatment for AMD: Update 2
And, the final update (until now) was written following the 2008 Retina Society Meeting in September 2008. This included 18-month data from the Phase II feasibility study, and concluded with the statement: “With the continued promise of these Phase II trial results, NeoVista continues to enroll patients in the company's pivotal trial, CABERNET. CABERNET is a multicenter, randomized, controlled study that will enroll 450 subjects at 45 sites worldwide, evaluating the safety and efficacy of NeoVista's epiretinal brachytherapy delivered concomitantly with the FDA-approved anti-VEGF therapy Lucentis (ranibizumab) versus Lucentis alone.”
NeoVista Epi-Retinal Strontium 90 Treatment for AMD: Update 3
This new update (Update 4) will attempt to bring you up-to-date on both the clinical trials underway, as well as provide a few quotes from the press releases announcing the patient treatments upon commercialization of the device in Europe.
Commercialization in Italy
From the press release about the first patients treated in Pisa, Italy, announced November 12, 2009:
The first VIDION patients were treated by Dr. Stanislao Rizzo, from the S. Chiara Hospital,Azienda Ospedaliera Universitaria Pisana, Pisa, Italy, who said, “We are very excited to be the first hospital to perform this innovative one time treatment procedure, which can help to treat a devastating disease that otherwise requires chronic treatment for an indefinite period of time. NeoVista’s targeted epimacular brachytherapy treatment may provide us the ability to improve vision by offering a distinct mechanism of action that affects multiple disease pathways unlike the conventional anti-VEGF therapy, and may dramatically change the patient’s quality of life by eliminating frequent eye injections. This promising treatment is a cost-effective alternative to treat neovascular AMD,” continued Dr. Rizzo. “Monthly injections can become quite expensive for our health care system, whereas a single procedure will potentially allow our specialists to treat more patients and bring down the costs associated with ongoing treatments.”
Commercialization in the United Kingdom
From the press release about the first patient treatments in London, UK, announced November 16, 2009:
The new device is initially being introduced in 15 hospitals across the UK as part of a large clinical trial called MERLOT, where it will be used in patients whose current standard of care treatment involves regular injections of a drug into the eye to control their condition (up to one injection every month, indefinitely). Although the treatment is initially only available at select hospitals, it is anticipated that the number of sites using the device will increase quickly, to provide nationwide availability.
The MERLOT trial has been recently awarded portfolio status by The National Institute for Health Research (NIHR) Comprehensive Clinical Research Network (CCRN). The CCRN was created as part of the government’s research and development strategy, “Best Research for Best Health” to provide a world-class infrastructure for clinical trials in all areas of disease and clinical need within the NHS in UK.
Mr Tim Jackson, a Consultant Eye Surgeon at King’s College Hospital, who is the lead investigator for MERLOT said: “This is a relatively straightforward operation and the published results are very impressive. My experience in our own trials of this device has also been encouraging and it is a big step forward to be able to offer patients this new treatment throughout the UK, within a large randomized controlled clinical trial.”
(For more on MERLOT, see the clinical trial section below.)
Commercialization in Germany
NeoVista, Inc. announced today the first commercial utilization of Epimacular Brachytherapy in Germany. Epimacular Brachytherapy is performed using the VIDION ANV Therapy system and is being offered as an adjunct therapy to anti-VEGF injections for the treatment of neovascular age-related macular degeneration.
John N. Hendrick, President and CEO of NeoVista commented, "Today is an extraordinary day for NeoVista, our local business partner, OctreoPharm Vertriebs GmbH, and the multitude of patients who suffer from this debilitating and life-altering disease. The burden of wet AMD to those afflicted with the disease, and their caregivers, is enormous."
Professor Gisbert Richard, Professor and Head of the Ophthalmology Department in the University Medical Center of Hamburg-Eppendorf, stated, "Our highly qualified medical staff is quite pleased to now be able to offer another therapeutic option to patients suffering from wet AMD - especially those patients who require frequent anti-VEGF injections." Multiple studies have demonstrated that injections alone are not able to effectively treat this disease in a large portion of the population."
Mr. Hendrick added, "The German health care system presents a welcome opportunity for NeoVista to demonstrate the effectiveness of this emerging technology. I believe the use of Epimacular Brachytherapy in the treatment of wet AMD will continue to gain momentum in Germany, and in many other countries, as the rising cost of health care, on a global basis, encourages more and more patients to continue seeking out additional or alternate therapies."
The NeoVista approach to treating wet AMD delivers a focused dose of strontium 90 beta radiation directly to the back of the eye, without damaging the adjacent healthy retinal vasculature. Importantly for patients, the systemic exposure to radiation is minimal and highly controlled to a local area. The effective dose to the entire body from NeoVista's device is less than that from a typical chest x-ray.
Clinical Trial Studies
The NVI-068 trial was a study of subjects treated with a single dose of 15 or 24 Gy epimacular brachytherapy. Safety parameters evaluated included incidence and severity of ocular adverse events identified by slit lamp and indirect ophthalmoscopic examination, fluorescein angiography, and optical coherence tomography. Patients will be followed in this trial for 3 years to evaluate safety. (24 month data has been presented.)
The NVI-111 trial was a study of subjects treated with a single dose of 24 Gy epimacular brachytherapy and two injections of bevacizumab (1.25 mg). Subjects received one injection prior to surgery (10±4 days) or at the time of surgery and the second injection at Month 1. Subjects were re-treated with bevacizumab per the investigator’s discretion at follow-up visits. Safety parameters evaluated included incidence and severity of ocular adverse events identified by slit lamp and indirect ophthalmoscopic examination, fluorescein angiography, and optical coherence tomography. Patients are being followed in this trial for 3 years to evaluate safety. (36 month data has been presented and submitted for Peer Publication)
MERITAGE I is a multi center international feasibility study designed to decrease the burden of treatment, it is fully enrolled (n=53) and is ongoing. The study is designed to evaluate the safety and efficacy of epimacular beta radiation therapy in patients that require persistent frequent anti-VEGF therapy to treat Wet AMD. It is planned for two sites, one in the US and one in the UK. (12 month data has been presented and a manuscript is being prepared for Peer Publication)
With the continued promise from the above two Phase II trial results (NV-068 and NV-111), NeoVista has finished enrollment in the company’s pivotal trial, CABERNET. CABERNET is a multicenter, randomized, controlled study that has enrolled 492 subjects at 45 sites worldwide, evaluating the safety and efficacy of NeoVista’s epiretinal brachytherapy delivered concomitantly with the FDA-approved anti-VEGF therapy Lucentis® (ranibizumab) versus Lucentis alone. (Initial results will be reported in Q4, 2011)
A pivotal study for FDA approval treating chronic wet AMD patients. (This study idea has been abandoned)
Special Population/Reimbursement Studies:
A feasibility study treating a specific vascular tumor. Begun in Q3 2009, and still underway..
An investigator-sponsored study in the UK; It is a head-to-head comparison of NeoVista epimacular beta radiation therapy and standard-of-care treatment with Lucentis®, begun in Q4 2009 and >40% enrolled.