Recent cancer therapies may give regulators headaches trying to figure out to approve it because the technology is so new. Is it a device or is it part pharmaceutical because something is injected? The “device” was described in presentation at a recent Comsol FEA conference and showed how fast technology is changing and how devices can do the work of some pharmaceuticals.

The little things in this case are nanospheres made under the guidance of Naomi Halas, a professor of electrical and computer engineering, chemistry, and bioengineering at Rice University in Houston. She is credited with the invention of nanoshells, nanoparticles with optical resonances spanning the visible and infrared regions. The nano-sized spheres are of a material her team designed that absorbs wavelengths of 810 nm, and critical figure as you shall see. It turns out that this infrared wavelength can penetrate the human body to a depth of about 10 cm.

It also turns out that tumors are greedy little growths anxious to send out lots of blood vessels so they can feed. Researchers have known that particular nanoparticles injected into the bloodstream will collect in a tumor in about four to six hours. Irradiating the tumor for just a few minutes with the 810-nm wavelength light warms Halas’ nanospheres. About 20 Celsius degrees is enough to kill a tumor. Halas showed pictures of lab mice before and after treatments. Large tumorous lumps were gone in a few days and did not return for the life of the mice.

Cool stuff. The FDA thinks so, too, and has approved clinical trials. But will they wrangle about what regulations to follow, or how to verify its effectiveness? Let's hope not.

-- Paul Dvorak