Medical Device Dailys

Royal Philips Electronics (Eindhoven, the Netherlands) will lead a European consortium to develop local drug delivery using nanoparticles activated by ultrasound.

Funded with €11 million ($14 million) from the European Union's Framework 7 program to stimulate innovation, the SonoDrugs project will gather 15 industrial partners, university medical centers and academic institutions located across the continent.

The partners will contribute a third of the financing for the four-year program, totaling €5 million ($6.5 million) as well as expertise and in-kind services for research and prototype development.

The program will focus on drug delivery for cancer and cardiovascular disease, exploring the use of existing nanocapsules filled with existing therapeutics as well as the development of new capsule materials combined with new medications, a Philips spokesman, Steve Klink, told Medical Device Daily.

Although powerful drugs are available to treat cancers and cardiovascular disease they are typically administered systemically as intravenous or oral doses, with very limited control over the distribution of drugs in the body.

The random interaction of these molecules with different tissues and organs is responsible for the heavy side effects often associated with these therapies.

The SonoDrugs project aims to address this challenge by developing drug delivery vehicles that can be tracked by ultrasound or MRI and triggered by ultrasound to release the drugs at a highly targeted site in the desired location. It is hoped that such control of the drug delivery process will increase therapeutic efficiency and minimize side effects, while also providing a means of tailoring the therapy to individual patients.

"New therapeutic options such as externally triggered local drug release at the specific site of disease hold the promise to significantly improve patient care," says Henk van Houten, senior vice president of Philips Research and head of Philips' healthcare research program.

He added that targeted drug delivery also holds the potential to tailor therapies for specific patients at different stages of treatment.

One of the program partners, Nanobiotix (Paris), received a European patent covering novel activable particles for use in medical applications in 4Q08 (MDD, Oct. 16, 2008).

The core of the company's current nanoXray product is a non-drug agent with at its core an inert and inactive substance called Nbtxr3 coated with a material taken up by cancerous cells, thereby attracting a concentration of particles on the diseased cells while leaving healthy cells untouched.

Introducing a blast of gamma rays from an everyday X-ray unit activates Nbtxr3 locally, setting off tumor necrosis by inducing a chain reaction where a reactive oxygen intermediate blocks the formation of free radicals and arrests the cytotoxic response of tumor cells (MDD, May 7, 2008).

"For Nanobiotix, collaboration with SonoDrugs valorizes the company's know-how in MRI contrast agents and activated therapies as well as nanoparticle design and manufacturing," said President/CEO Laurent L vy, PhD, who also is co-president of the French Technology Platform on Nanotechnology (FTPN). He called the SonoDrugs program a "groundbreaking" effort.

Meanwhile Philips said it has two other programs for local drug delivery using ultrasound activation currently in late-stage development.

Philips is working with the University of Virginia (Charlottesville) on a 4-micron microbubble loaded with an anti-cancer therapeutic that is in pre-clinical development and it has announced a collaboration with Celsion (Columbia, Maryland) encapsulating the approved drug Docetaxel s in that company's ThermoDox shell which is activated by MRI-guided high-intensity focused ultrasound (HIFU) system (MDD, Oct 17, 2008).

Use of proven chemotherapeutics is believed to lower development risk and accelerate speed-to-market for drug-device combination through clinical programs that are less complex.

Yet Klink cautions against this rush to market, saying the development timeline remains fixed closer to a pharmaceutical development than a medical device approval cycle.

"Microbubbles and the drugs they contained are approved for specific indications so that new combinations and new materials means approvals are not as straightforward as a device maker would expect," Klink told MDD, adding that a 10-year horizon is more likely for any product emerging from the SonoDrugs program.

Other partners on the program include Lipoid (Germany), the university medical centers Erasmus Medical Center (the Netherlands) and Universitäts Klinikum Münster (Germany), and the academic institutions University of Cyprus (Cyprus), University of Gent (Belgium), University of Helsinki (Finland), University of London (UK), University of Tours (France), University Victor Segalen Bordeaux (France), University of Technology Eindhoven (the Netherlands) and the University of Udine (Italy).

AGA seeks damages in Germany

AGA Medical (Plymouth, Minnesota) said that, following the previously reported favorable patent infringement final ruling by the German court of appeals over Occlutech (Jena, Germany), it has notified Occlutech of the amount of damages that it will seek from Occlutech based on the court's ruling.

No specific amount was reported.

The U.S. company said that after learning that Occlutech has terminated all manufacturing and sales and that its CEO had resigned, it has started proceedings in the insolvency court in Germany to protect AGA's claims for damages.

The lawsuit was brought by AGA in 2006 in Dusseldorf, Germany, seeking to enjoin Occlutech from infringing the German part of AGA's European patent, EP 0 808 138, and for resulting damages.

The final ruling in favor of AGA from the German court of appeals was reported in early January.

AGA develops devices for a range of structural heart repair and circulatory conditions, including treatment of the most common congenital "holes in the heart," such as atrial septal defects and patent foramen ovales.

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