QED Award Supports Efforts to Commercialize Magnetically Driven Nanoparticle Technology

09/16/2010

Investigations led by Robert Levy, M.D., The William J. Rashkind Endowed Chair in Pediatric Cardiology at Children’s Hospital, have introduced a new delivery system to magnetically target therapeutic agents to catheter-deployed stents. This novel idea has the potential to become a major platform technology for delivering drugs, cells, and other agents to specific sites in diseased or injured blood vessels. Dr. Levy recently received an award from the University City Science Center’s QED Proof-of-Concept Program to support his efforts toward developing and commercializing this technology as a therapy called vascular magnetic intervention (VMI).

The QED Award facilitates interactions designed to accelerate the development of technologies and rapidly translate them into products available to advance patient treatments. Award winners are supported by the QED Program’s business development components including business advice from an advisor with a background in project development and implementation; a 12-month, $200,000 grant for early-stage research and development that includes matching funds from the investigator’s research institution; and guidance from industry and investment experts who periodically review the project and guide the technology from the QED program into the private sector.

Dr. Levy and his team in the Division of Cardiology at CHOP were selected to receive the QED Award for their VMI research proposal following a rigorous, two-stage competitive review process that included an evaluation of the scientific merit of the technology and its potential for commercialization. The project was matched with business advisor Richard Woodward, Ph.D., a molecular biologist who spent much of his career helping biopharmaceutical companies develop their products.

Dr. Levy’s VMI delivery system is a combination therapy that builds upon existing stent technology by directing biodegradable nanoparticles loaded with an antiproliferative drug, paclitaxel, to stents using uniform field magnetization. Dr. Levy’s team first presented the VMI mechanism in the January 2008 issue of Proceedings of the National Academy of Sciences. A feasibility study conducted by Dr. Levy’s team, presented in the May 2010 issue of the same journal, demonstrated that VMI effectively prevented restenosis in the stented carotid arteries of rats and provided sustained drug release over the 14-day course of the study.

One of VMI’s potential applications is treating peripheral arterial disease (PAD), a buildup of plaque that can harden and narrow the arteries. The condition affects more than 27 million individuals in North America and the European Union. The 9 million PAD patients who suffer from symptoms experience pain and numbness in their legs, which often becomes so severe they can no longer walk. Surgery and the use of stents, small mesh tubes that hold the artery open, have had limited success in treating PAD. While stents that elute an antiproliferative drug that prevents blockages from forming have been helpful in treating coronary artery disease, they have been not shown in long-term controlled studies to be of significant benefit for treating PAD.

Unlike drug-eluting stents that contain one fixed dose, VMI offers the possibility of providing a variable initial dose based upon the extent of disease and can be readministered for either redosing or treatment with a different agent. Additionally, because the magnetic effect concentrates its delivered agent at the specific site of a stent, VMI could be used to achieve stronger effects with lower overall doses of a given agent than is possible with existing routes of administration. In children, who do not commonly suffer from PAD, VMI could eventually be used to deliver drugs to improve outcomes in a number of stent-based interventions in pediatric cardiology for conditions such as peripheral pulmonary artery stenosis, coarctation of the aorta, and atrial septal defects.

Drs. Levy and Woodward are working together to identify a strategy for quickly translating this technology from an academic pursuit to a treatment reality. To keep development on track, Drs. Levy and Woodward meet weekly along with staff from the Office of Technology Transfer to monitor the progress of Dr. Levy’s research and to discuss market analysis results, sources of venture capital, and the status of their funding applications to resources such as the Small Business Innovation Research, BioAdvance, and Ben Franklin Technology Partners programs.

Current investigations at CHOP Research supported by Dr. Levy’s QED Award include a preclinical proof-of-concept study that evaluates the distribution of paclitaxel when administered using VMI and that compares restenosis in animals treated with stents and VMI to deliver paclitaxel and those treated with bare metal stents and no paclitaxel. The investigations, conducted in rabbits that have had stents implanted in their femoral arteries, will use paclitaxel doses well below the doses loaded onto current drug-eluting stents. The model for this study has previously been used in other preclinical studies submitted to the Food and Drug Administration for Investigational New Drug Applications.

“It is exciting to see something go from the design phase to a new instrument, ” says Dr. Levy. “The group working on this project is very energized. We’ve proposed to do a lot during the year and have hit all of our targets so far.”

VMI has the potential to be a highly successful commercial product that could improve the health of a large number of patients. In addition to the likely need for both primary and repeated VMI treatments for PAD, the technique is versatile and could possibly be used to deliver a broad range of effective therapeutic agents. The potential of this technology has been noted as interesting and promising by many academic journals, including Science Translational Medicine and the Journal of the American Medical Association, and the popular press, such as Forbes, which named it one of five promising new technologies.

The QED award ends in May 2011, at which point Drs. Levy and Woodward will continue their translational efforts with external sources of funding. Drs. Levy and Woodward are working closely with the Office of Technology Transfer to form preliminary plans for technology licensing.