A Medical Device Daily

NeoVista (Fremont, California) said the first European patient has been treated in the company’s pivotal global clinical trial for its novel beta radiation epiretinal therapy for the wet form of age-related macular degeneration (AMD).

Wet AMD is the most progressive form of AMD and one of the leading causes of blindness in the industrialized world for patients over age 50.

The current standard of care requires costly monthly eye injections, but NeoVista’s investigational therapy delivers a one-time dose of radiation, providing a less-invasive and potentially more cost-effective treatment option, according to the company.

The procedure was performed as part of NeoVista’s CABERNET (CNV Secondary to AMD Treated with BEta RaditioN Epiretinal Therapy) trial, which seeks to enroll a total of 450 patients — 300 in the radiation treatment arm — in about 40 sites worldwide to evaluate the efficacy and safety of NeoVista’s radiation therapy.

Patients in the study receive a single treatment with NeoVista’s targeted radiation in combination with an injection of Lucentis at the time of radiation delivery to maximize immediate effect.

In addition to Germany, locations of CABERNET study sites include the UK, Spain, Switzerland, Austria, Israel, Brazil, Mexico, Peru and the U.S. The study is intended to support eventual filing for regulatory approval to market the product worldwide.

“We’re excited to have the opportunity to try this innovative technique with our patients,” said Christian Foja, MD, of Leipzig University Eye Hospital, who performed the first procedure.

“NeoVista’s targeted radiation treatment may provide us the ability to improve vision for the elderly and dramatically change their quality of life by eliminating frequent eye injections,” said Peter Wiedemann, MD, who oversees the department at Leipzig University Eye Hospital.

NeoVista’s radiation device delivers the peak dose of radiation directly to the lesion minimizing radiation exposure to the surrounding tissue. The minimally invasive procedure uses a device similar in size and appearance to a fountain pen, to deliver a highly focused radiation directly to the area of the retina affected by wet AMD. The exposure to radiation is minimal.

“Our goal is to restore vision and quality of life to elderly patients who have been stricken with this debilitating disease by liberating them of the burdens associated with existing wet AMD therapies,” said John Hendrick, president and CEO of NeoVista. “As our clinical trials continue to show positive results, we are getting closer to achieving that goal and delivering a real solution to physicians and patients.”

Varian to equip new hospital in UK

Varian Medical Systems (Palo Alto, California) said it has been selected to provide radiotherapy equipment for a major new hospital in Portsmouth, UK.

In what the company said is one of the country’s largest replacement projects since the investment waves of the UK government’s Cancer Plan earlier this decade, the new Queen Alexandra Hospital will receive four high-energy Clinac iX linear accelerators equipped with On-Board Imager devices for advanced image-guided radiation therapy (IGRT) treatments.

Due to open in summer 2009, thehospital will enable all acute services currently spread across three sites to be brought together under one roof. This includes the current oncology center at St. Mary’s Hospital. The new facility will serve a population of 600,000 people.

Tony Palmer, the hospital’s head of radiotherapy physics, said, “This new facility will mean we can offer local cancer patients treatments that are truly state-of-the-art internationally. We will also be one of the only NHS cancer centers in the UK with every one of our treatment machines equipped for 3-D image-guided radiotherapy, which we feel is crucially important.”

Clinicians at St. Mary’s Hospital are about to introduce highly-conformal intensity modulated radiotherapy (IMRT) treatments, and that program will be expanded once the new machines are installed. An Acuity simulator at the current facility will be transferred to the new site next year and will have Varian’s 4-D respiratory compensation functionality added.

Cavidi in viral-load assay agreement

Viral load monitoring assay maker Cavidi (Uppsala, Sweden) reported an agreement with the Clinton Foundation HIV/AIDS Initiative (CHAI), with the company’s ExaVir Load assay to be immediately available to members of CHAI’s Procurement Consortium at a discounted price.

More than 70 developing countries are involved in the consortium, so the company said the agreement is a “significant step in making viral load monitoring more accessible to HIV-positive patients in the developing world.”

Viral load monitoring is used in the management of HIV-positive patients being treated with antiretroviral drugs (ARVs). The company said the test helps doctors”use ARVs more effectively to extend a patient’s length and quality of life, limit the development of viral resistance and minimize waste of medication.”

“As more people in the developing world gain access to ARVs, it’s important that access to viral load testing keeps pace,” said Cavidi CEO Martyn Eales. “It’s [our] goal to make monitoring more accessible in all countries; I’m pleased with our partnership with President Clinton’s foundation because it brings us closer to reaching that goal.”

Cavidi said ttraditional viral load tests are expensive and require technically advanced laboratory facilities, but ExaVir Load “is the first HIV viral load test designed to overcome these obstacles.”

The company added that several independent studies “have shown the assay to be as accurate and reliable as any other commercially available test, with the added benefit of being able to detect all known subtypes of HIV. This is particularly important in regions like sub-Saharan Africa, where different HIV subtypes are common.”

Cavidi was founded by virologists at Uppsala University in 1984.

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