A Medical Device Daily

The Institute for Health Technology Studies (InHealth; Washington) has awarded one-year research grants to two teams at Stanford University (Palo Alto, California). The grants, totaling $538,207, are part of InHealth’s goal of bringing objective data and perspective to understanding the impact of medical technology on patients and the healthcare industry.

One project will examine the socio-economic value of MRI and computed tomography (CT) imaging. The other will document the current regulatory and commercialization processes required of new medical technologies.

The first study, “The Diffusion of Imaging Technologies, Health Care Costs and Quality,” will investigate the relationships among the availability of advanced diagnostic imaging services, usage, patient outcomes and healthcare spending.

The second study, “Medical Device Development Models,” will document how medical devices are approved and enhanced, pre- and post-market, including the role of the FDA. In addition, the study will clarify the different paths followed by medical devices, pharmaceuticals and biotech products. Results from both studies are anticipated by fall 2007.

In other grant news:

• Inovio Biomedical (San Diego) said it is slated to receive $1.1 million from the U.S. Department of Defense to develop applications of its electroporation-based gene delivery technology for vaccination against infectious disease, including potential bioterrorism agents.

Congress appropriated the funding in the Defense Appropriations Bill for 2007 as a continuation of prior funding from the Army to the company, focused on the development of a more effective delivery system for gene-based vaccines.

Inovio said it is working on this project with Connie Schmaljohn, MD, a world-renowned virologist and chief of the Department of Molecular Virology at the U.S. Army Medical Research Institute of Infectious Diseases (Ft. Detrick, Maryland).

The premise of gene-based immunization is that for a particular targeted pathogen, selected DNA sequences can be introduced into muscle where they will produce one or more antigens and thereby elicit both cellular and humoral immune responses against that pathogen.

Inovio’s system is designed to use intramuscular electroporation to enhance the cellular delivery and expression of the DNA agents to produce the desired antigens. Compared to conventional vaccines, DNA vaccines delivered using electroporation may accelerate the onset and enhancing the level of immunity generated, critical in attempting to address threats posed by pandemics or bioterrorism, the company says. Pertinent genes can be quickly identified and isolated from potential infectious organisms, sequenced, and synthesized for vaccination of the general population or military in order to induce a protective immune response.

The company said in a statement: “DNA vaccines delivered with electroporation are of interest to the medical community, Inovio said, because they provide the advantage of rapid and robust immune responses. They are effective at triggering both enhanced cellular and humoral immune responses — mediated by certain white blood cells and antibodies, respectively — that are difficult to achieve by conventional vaccine technology and provide superior immunity to the toxic challenge posed by infectious agents.

The company said that DNA vaccines delivered by electroporation “have been shown to reprogram the immune system to recognize antigens on cancer cells that had not otherwise been recognized.”