Westminster, Colorado based GeneThera Inc., a biotechnology company specializing in zoonotic diseases that can afflict both animals and people, recently announced it will have a new laboratory facility operational this spring. The facility will help the development of therapies for conditions such as Crohn’s disease.

“This is an important step towards expanding our molecular robotics and DNA therapeutic vaccine platforms,” said Tony Milici, M.D., Ph.D., founder and CEO of GeneThera, in a press release.

GeneThera’s plan is to move into the new laboratory once renovation is complete. The anticipated move-in day is March 31. The 8,000-square-foot facility will have a fully integrated molecular robotics laboratory housing GeneThera IRSA robotic equipment for different tests, including Crohn’s disease, through a highly sensitive detection capability for Mycobacterium Para tuberculosis.

“In addition,” said Milici, said, an expert in molecular biology, “we will have a state-of-the-art DNA vaccine laboratory fully dedicated to the development of Johne’s and Crohn’s disease therapeutic vaccines.”

While most people are aware of Crohn’s disease — a severe, devastating, and potentially lethal chronic inflammatory disorder of the human intestine — and may know someone who suffers from it, Johne’s disease (JD) has a much lower public profile, although many believe there is an important link between the two diseases.

Johne’s disease, an incurable chronic granulomatous inflammatory intestinal disorder, is found worldwide in both domestic and wild animals, and its prevalence in dairy cattle, sheep, and goats is a particular public health concern. Johne’s is named for the German veterinarian who first described it in a dairy cow in 1865. Because it is caused by infection with Mycobacterium Avium Para tuberculosis (MAP), the disease is also sometimes referred to as paratuberculosis.

The MAP bacterium, which cannot replicate outside of animal hosts, grows very slowly, causing a gradually worsening disease condition that is highly resistant to the infected animal’s immune defenses. Consequently, infected animals harbor the organism for years before they test positive for JD.

GenaThera estimates that more than 70 percent of the U.S. dairy cow herd is infected with MAP, based on an array of scientific studies that have shown a relationship between Johne’s and Crohn’s disease. The company points out that MAP is resistant to standard pasteurization procedures, and recent studies have also turned up baby formula samples testing positive for MAP infection.

The company says an “overwhelming number” of studies point to a relation between Johne’s disease and Crohn’s, noting that approximately 80 percent of Crohn’s patients test positive for Mycobacterium paratubercolosis infection when examined by an intestinal biopsy.

GeneThera maintains that drinking milk from cows infected with Johne’s disease is the most common vector for exposing people to paratuberculosis infection, noting that milk is the “logical” focus of exposure because cows with Johne’s disease secrete MAP abundantly in their milk. Researchers cited studies conducted in Europe, including a Swiss study in 2003, in which 1,384 bulk milk samples from different regions were tested for M. paratuberculosis, with 19.7 percent testing positive for the bacteria. It is significant that cows from Swiss farms were predominantly asymptomatic — apparently ill, but not producing the sort of massive diarrhea that characterizes the latter stages of M. paratuberculosis infection.

A 2000 study, “Mycobacterium avium subspecies paratuberculosis in the causation of Crohn’s disease,” was published in the World Journal of Gastroenterology by Dr. John Hermon-Taylor, one of the world’s leading experts on Crohn’s disease, a retired professor from St. George’s Medical School in London whose research on MAP and its relationship to Crohn’s has spanned more than 30 years. In the article, Hermon-Taylor, who currently runs the CrohnsMAPVaccine website, explains in detail the link between Johne’s and Crohn’s diseases that many experts believe is in play.

“I am absolutely certain that some strains of MAP can be pathogenic for humans and can cause Crohn’s disease in susceptible people,” Hermon-Taylor said in the GeneThera press release. “Since MAP is known to be a primary specific cause of chronic inflammation of the intestine in many different species, including primates, it would be remarkable if it did not cause disease in humans.”

In a recent study published in the journal Expert Review of Gastroenterology & Hepatology, titled “Mycobacterium paratuberculosis as a cause of Crohn’s disease“, co-authored by Adrienne L. McNees and David Y. Graham of Baylor College of Medicine in Houston, researchers noted that the cause of Crohn’s, which afflicts approximately 1.4 million North Americans, is officially unknown although MAP has long been regarded as a potential cause.

They said that MAP is widespread in dairy cattle and that due to environmental contamination and the bacterium’s resistance to pasteurization and chlorination, humans are frequently exposed through contaminated food and water.

The authors also observed that MAP can be cultured from peripheral mononuclear cells from 50 to 100 percent of Crohn’s disease patients and less frequently from healthy individuals. Cautioning that association does not prove causation, the investigators outline what data will be required to prove the hypothesis that MAP is a potential cause of Crohn’s disease.

GeneThera believes that because many disease agents are transmissible between humans and animals, causing infection in both species (zoonotic), their management and prevention are crucial to improve public health globally. Convinced that better technologies and methodologies need to be implemented to help control emerging zoonotic diseases, the company says it is focused on developing molecular diagnostic tests, therapeutics, and vaccines in the belief that zoonotic diseases left unchecked — such as Johne’s disease, mad cow disease (Bovine spongiform encephalopathy), chronic wasting disease, and E. coli — will likely continue to cause serious and growing problems in terms of economics, human health, and biodiversity.

GeneThera’s proprietary diagnostic solution is based on a genetic expression assay (GES) and management system HERDCHECK, designed to function on an automated molecular robotics platform that enables GeneThera to offer tests not currently available from other technologies.