This report originally appeared in the June 2011 issue of DOTmed Business News

Recent budget talks on Capitol Hill have focused national attention on divisive ideological issues. But while Republicans and Democrats nearly shut down the government during their extended standoff, both sides agreed—almost unanimously—on one thing: nanotechnology.

Tucked away in the 2012 federal budget is $2.1 billion earmarked for the National Nanotechnology Initiative, which coordinates nanotechnological research and development across several federal agencies. The budget signifies an increased investment by Congress, marking a 16 percent increase for the NNI from the last year.

Launched in 2000, the NNI began with eight agencies and a paltry budget of $464 million. Now, the NNI is a collective of 25 federal agencies. And as the NNI has grown, so too has its funding—by nearly 300 percent in the past decade.

The federal government’s support and investment could not come at a better time. Dr. Piotr Grodzinski, program director of the NIH’s National Cancer Institute’s Nanotechnology program, says nanotechnology is poised to make a significant difference in the field of medicine.

“There’s quite a bit of potential,” says Grodzinski. “You can entertain possibilities, you have indications of what nanotechnology can bring.”

Although fast growing, nanotechnology is concerned with the smallest of units—the nanometer. As a unit of measurement, the nanometer is a billionth of a meter and is no wider than ten atoms in a row. The Food and Drug Administration defines nanotechnology as anything that operates between 1 and 100 nanometers in length. At this scale, an ant is a million times as large as a single nanoparticle.

History a long time in the making
In recent years, there has been a flurry of research in nanomedicine, especially in cancer therapies and, to a lesser extent, vaccine development. Several initiatives have now entered clinical trials. If previous drug development timelines are any indication, nanopharmaceutical products could be entering the marketplace within the next five to ten years.

This shift towards the microscopic is not new. Nanotechnology has been in existence since the 1800s. Yet, it has largely been confined to electronics and materials engineering. Nanotechnologies most consumers are familiar with include the computer and the black filler in rubber tires. Medical applications, on the other hand, have so far been confined to laboratories.

But in recent years, Grodzinski says, nanomedicine has been moving from laboratories to the marketplace. In his six years as program director, Grodzinski says he’s noticed a considerable change in the volume and focus of research.

“The field is more mature,” says Grodzinski. “More people are working on it, and there are more companies being spun off from universities to commercialize this technology. Translational efforts are starting to move forward.”

Nanomedicine’s debut and potential
One of the earliest success stories of nanomedicine has been Abraxane, a breast cancer drug that entered the market in March 2005. At the time of its introduction, nanomedicine was still a negligible segment of the pharmaceutical industry. At only $8.5 billion of the world’s market, nano-biotechnology was still a nascent field, characterized more by its idealism and media hype than its marketability.

Today, Abraxane, now a product of Celgene Corporation, has more than $400 million in annual sales. The product’s success has paralleled the growth of the industry as a whole. This year, nanobiotechnology is predicted to reach a global marketshare of $20.8 billion.

As the literature in nanotechnological research expands, so do the possibilities for drug makers. Other researchers and companies are seeking to mimic Abraxane’s success, perhaps even surpass it.

Dr. Larry Tamarken, president and CEO of CytImmune Sciences Inc., a Rockville, Md.-based nanomedicine company, sees cancer therapies as the next logical step for nanotechnological research. According to Tamarken, the reason for the industry’s focus on cancer therapies is two-fold: the growing medical need for more successful cancer treatment options, and the nature of nanoparticles themselves.

“On average, you have a one in 10 chance that any chemotherapy protocol will be successful,” says Tamarken. “The question we ask is, why can’t we do better?”

Tamarken says the more realistic goal,is not to cure cancer, but rather to treat it like a chronic disease, not unlike diabetes. CytImmune Sciences’ product, a drug called Aurimune, uses gold nanoparticles to deliver tumor necrosis factor (TNF) to cancer cells. It enters clinical trials this year.

Traditional treatment of solid tumors like breast cancer has been a combination of chemotherapy and surgery. Aurimune bypasses these methods entirely. Tumors need blood vessels to sustain their growth, but these blood vessels are poorly constructed and leaky, with holes ranging from 200 to 400 nanometers in diameter.

At 27 nanometers, Aurimune’s gold nanoparticle can easily exit the blood stream at these cancer-specific sites and deliver TNF. The drug then binds to the tumor’s blood vessels and causes them to die off.

The size of nanoparticles is what makes them such attractive candidates for cancer therapy. Conventional chemotherapy relies on high doses of drugs and indiscriminate targeting. Both healthy and cancerous cells are exposed to toxic chemicals that may or may not have the intended effect. “In the world of nanomedicine, cancer is the lowest hanging fruit, the easiest target,” says Tamarken.

Dr. Bob Langer, an Institute Professor at the Massachusetts Institute of Technology, has also harnessed nanoparticles to treat cancer. Langer has been on the frontline of nanotechnological research for the past twenty years and operates the world’s largest academic bioengineering lab. One of Langer’s nanoparticles is currently in clinical trials through Bind Biosciences, a Cambridge, Mass.-based company that Langer co-founded.

According to Langer, nanotechnology lends itself to the field of cancer therapies because of its ability to deliver high concentrations of drugs at specific targets but without many of the side effects associated with chemotherapies. The medical nanoengineering platform that Bind Biosciences is currently testing involves nano-sized doses of cancer drugs.

But Langer’s technique coats the drug with plastic to control the rate of the drug’s release into the system. A secondary coat of water protects the drug from the body’s immune system. Finally, markers are added to direct the drug to its target. The end result, Langer says, is target-specific, controlled release of cancer therapies that can be anywhere between 1,000 and 100,000 times more powerful than traditional treatments.

The scale of nanoparticles also makes them attractive for other areas of medical research. NanoBio Corporation, an Ann Arbor, Mich.- based company, is currently in clinical trials for a topical herpes labialis treatment for cold sores at the site of infection. The company, originally a spin-off of research at the University of Michigan, entered into an agreement with GlaxoSmithKline in December, 2009.

Their product uses emulsions composed of nanometer-sized droplets, each a combination of two detergents, oil, and water—to treat infections. At 200 nanometers, the emulsions are small enough to easily permeate the skin and treat the virus, but big enough to avoid absorption into the blood stream. Unlike traditional antibiotic and antifungal treatments, nanoparticles would eliminate the need for systemic-wide treatment of many localized infections.

A little problem
Dave Peralta, NanoBio’s chief operating and financial officer, agrees that the size of nanodroplets make them an ideal solution for the pharmaceutical industry. But Peralta also points out that nanotechnology’s strength might also be its weakness.

In the spring of 2004, researchers reported brain damage in largemouth bass that had been exposed to buckyballs, a commonly used carbon-based nanoparticle. Later reports found that nanoparticles could accumulate in the environment. The findings ignited what continues to be a lingering concern regarding nanoparticles.

“There’s been more scrutiny for very small nanoparticles,” says Peralta. “There are concerns about toxicity, and about their ability to get into the bloodstream and into distant organs.”

But these concerns are specific to the smallest of nanoparticles, those smaller than 10 nanometers, Peralta points out. “In nanomedicine, there’s a wide range within which people operate,” he says. “Because concerns are raised regarding those specifics, the whole nano space gets painted with broad strokes.”

Despite these concerns, the FDA decided in 2007 not to require any additional safety trials for nanomedical initiatives. Grodzinski sees the FDA’s decision as a vote of confidence for the relatively new field.

“It’s the nature of medicine and medical sciences to be cautious,” says Grodzinski. “There is also some hesitation to adopt new concepts. This perception will be a major barrier, but there is a strong body of knowledge that nanoparticles will make a difference.”