Diagnostics & Imaging Week and Staff Reports

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 Diagnostics & Imaging Week.

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.

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.

"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 Lévy, 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.

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 D&IW, 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).

UK study eyes C. difficile 'code'

The British Midlands Development Corp. (Chicago) said that scientists at the University of Nottingham in the UK are leading a major European study to unravel the genetic code of one of the most lethal strains of hospital-acquired infections.

The $4.5 million, three-year study will use gene knock-out technology developed in Nottingham to study the function of genes in a "super" strain of the bacteria Clostridium difficile, to discover why it causes more severe disease, kills more people, is harder to eradicate and more resistant to antibiotics.

It is hoped that the study will lead to better tests to diagnose "super" strains of C.difficile, more effective treatments and, possibly, even a vaccine to protect against the disease. There is very little known about the ways in which the bacteria operate and why the strain should be more severe than its less virulent cousins.

During the three-year study, scientists at Nottingham will use a technology called ClosTron to produce mutant versions of the hypervirulent strains. They will knock out genes one by one and then compare the mutant version to the standard organism to assess the function of each cell.

The Centre for Healthcare Associated Infections (CHAI) was established at the University of Nottingham in late 2006. CHAI consists of researchers from the university, together with clinical colleagues from Nottingham University Hospitals NHS Trust.

The British Midlands Development Corp. is the North American economic development agency for central England. The Midlands region is located one hour to the north of London and includes the major commercial centers of Birmingham, Nottingham, Coventry and Northampton. The region is at the heart of the UK's life sciences industry.

Additional markets for SenoRx

SenoRx (Irvine, California) reported that it has extended its international reach to encompass additional global markets. In addition to the 24 countries where SenoRx products are already being sold internationally, the company will begin marketing EnCor, its vacuum-assisted breast biopsy product, and its GelMark line of breast biopsy tissue markers through distributors in Egypt, Greece, Poland, Saudi Arabia, Thailand, Turkey and the United Arab Emirates.

SenoRx is partnering with local distributors who have breast imaging and/or interventional radiology franchises in select markets.

"SenoRx continues to expand its international footprint in key markets where breast care is increasingly becoming a national healthcare priority," said President/CEO Lloyd Malchow. "We have had positive results with our earlier international expansion initiatives and continue to see attractive opportunities for growth in the global marketplace. With the addition of these seven new geographic markets, SenoRx will now have a presence in more than 30 countries outside North America."

EnCor and SenoRx breast tissue biopsy markers have received the necessary regulatory clearances in countries within the European Economic Community and in all of the other countries where it has established distribution channels.

The company has previously established partnering relationships with distributors in Australia, Austria, Belgium, Denmark, Finland, France, Germany, Hong Kong, Iceland, Ireland, Italy, Luxembourg, Mexico, the Netherlands, Norway, Portugal, Russia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan and the UK.

Australia's CSIRO develops sensor

The Commonwealth Scientific and Industrial Research Organization (CSIRO; Campbell, Australia) reported that it has developed a new concept of measuring surface pressure called the Acoustic Pressure Sensor (APS) and will release an Expression of Interest (EOI) form on Feb. 13 to find a partner who foresees commercial benefit in investing in the further development, production, clinical trials and global market development of the technology.

The sensor is made of an inert material and has no built-in electronics. When the sensor is subjected to sound waves, it reradiates some of the sound waves with the pressure information encoded within the reradiated sound waves. This allows the remote measurement of absolute pressure in the fluid that is in contact with the sensor.

CSIRO said an example of where the APS may be used is in the treatment of aortic aneurysms.

Such aneurysms usually are treated by the use of stent-grafts. If placed correctly, blood will flow through the stent graft and the blood pressure will be removed from the weakened sections of the aorta. If a stent graft is placed incorrectly, then the aneurysm is still exposed to direct blood pressure and it will keep on expanding, eventually rupture and potentially cause a fatal internal injury, CSIRO said.

It said that by placing the sensor on the outside of the stent graft and thereby excluding the aneurysm, the sensor will detect the change in pressure from systemic blood pressure to the lower, internal body pressure.

This device also can be used as a monitoring tool for ongoing patient care.

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