The new process, called Nanotemplate Engineering, was developed by two researchers from the University of Kentucky and has been licensed to NanoMed Pharmaceuticals - a start-up company they founded in 2000.
The technology is used to formulate small molecules, peptides, proteins, plasmid DNA, and diagnostic agents.
As a drug delivery system, Nanotemplate Engineering can provide a sustained release of drugs in tissues, which may reduce dosage frequency, peripheral toxicity and adverse effects. The process also may enhance efficacy and expand the indications for which a drug may be prescribed, the researchers said.
This latest patent illustrates what can be called a patent boom, as universities and other organisations rush to patent new technology. Indeed, according to the National Cancer Institute, from 1980 to 2003, the yearly number of US patents obtained by universities worldwide soared from approximately 250 to 4,000, and the revenue from patents is becoming an important part of the financial strategy of major universities.
While universities and public interest foundations typically hold about one percent of patents issued in the U.S. each year, this number spikes to 12 percent in emerging nanotechnologies.
"Nanotemplate Engineering may have a special appeal to pharmaceutical manufacturers because it can provide new patent protection for current or soon-to-be off-patent drugs," said Stephen Benoit, president and CEO of NanoMed Pharmaceuticals.
The new technology involves a quick, reproducible and scalable process to manufacture nanoparticles without the need to use expensive equipment commonly required to make to make other types of pharmaceutical delivery systems, the researchers said.
"We created and developed an engineering process to make nanoparticles that literally takes minutes, and can involve simply mixing all of the ingredients and the drug in a single vessel," said Russell Mumper, associate professor and vice chair of the department of pharmaceutical sciences at the University of Kentucky.
"These nanoparticles can deliver proteins, diagnostic agents and other materials to specific tissues, cells and tumours."
According to Michigan-based NanoMed, this new process could prove even more interesting for anti-cancer treatments as the research has shown that these nanoparticles, when produced to contain anti-cancer drugs, can deliver the drug more effectively to cancer cells that have developed resistance to the drug when administered alone.
"Based on these data, NanoMed is utilising nanotemplate engineering to develop its lead product which is intended to overcome multidrug resistance in remission induction therapy in elderly acute myelogenous leukaemia (AML) patients," said Benoit.
This product is currently in preclinical development and the company expects to begin safety and efficacy tests in AML patients in early 2008.
The company's lead product incorporates a compound that is a proven anti-leukemic agent for the treatment of acute leukemias.
Leukemia, a cancer of the bone marrow and blood characterised by the uncontrolled accumulation of immature blood cells, is primarily a disease of the elderly with the median age at diagnosis of 68 years.
Leukemia in elderly AML patients is resistant to chemotherapy and patients suffer inferior outcomes. In addition, many elderly AML patients are not offered or refuse standard induction and post-remission therapy.
Therefore, an efficacious, relatively non-toxic approach is expected to be welcomed by patients and leukemia treatment specialists, the firm said.