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Professor patents test for possible Crohn’s disease cure

Senior staff writer

Published: Wednesday, October 5, 2011

Updated: Wednesday, October 5, 2011 16:10

Crphn's research

Carrie Canova/Central Florida Future

UCF professor Dr. Saleh Naser, center, patented the MAP bacterium diagnostic technology in 2009 with hopes of using it to help cure Crohn’s disease patients.

The UCF Research Foundation has licensed a promising diagnostic test for the detection of the mycobacterium avium paratuberculosis, also known as MAP, bacterium in humans to an international biopharmaceutical company that is developing a treatment for Crohn's disease.

The diagnostic technology is able to diagnose MAP infection in humans using DNA testing based on nested PCR molecular technology. MAP is present in roughly 50 percent of people who suffer from Crohn's disease and could be a leading cause of the disease.

Dr. Saleh Naser, a professor in the Burnett School of Biomedical Sciences in the College of Medicine, patented the diagnostic technology in 2009 with hopes of using it to help cure Crohn's disease patients who are positive for the MAP bacterium.

Crohn's disease is an inflammatory disorder of the gastrointestinal tract affecting about 700,000 people in the United States alone, with no cure.

"Our goal with this technology is to help speed the process of diagnosing, treating patients with the correct antibiotics and helping the patient begin remission as soon as possible," Naser said. "We want to see a change in these patients' lives."

Now that RedHill Biopharma Ltd., an emerging international biopharmaceutical company, has licensed Naser's diagnostic technology, Naser is closer to achieving his goal of diagnosing and treating Crohn's disease patients.

RedHill Biopharma Ltd. is currently developing an oral drug called RHB-104, which is intended to treat and possibly cure Crohn's patients with MAP bacterium, but without a way to detect MAP, the use of the drug has been limited. Partnered with the UCF Research Foundation, RedHill Biopharma Ltd. is able to use Naser's diagnostic test to detect MAP DNA in the patient's blood and finally allow physicians to prescribe RHB-104 to Crohn's disease patients.

"Our findings in our lab since 2000 is instrumental evidence showing that MAP is a significant part of this disease, and therefore the technology to detect such pathogens is extremely useful for diagnosis and ultimately treating this disease; and with that, our partnership with RedHill is sure to be valuable," Naser said.

Under the license agreement, in consideration for an exclusive license for all indications and medical applications, RedHill Biopharma Ltd. will pay UCF an upfront payment, as well as future net sales royalties of 7 percent to 20 percent.

Despite monetary advantages, Naser is most looking forward to putting his technology to use. RedHill Biopharma Ltd. is currently in discussion with Naser regarding the use of his technology to screen Crohn's patients for MAP infection to determine whether RHB-104 would serve as an effective treatment option in two parallel placebo-controlled, double-blind clinical trials, one in the U.S. and Canada, and one in Europe.

The trials will last two years and from there, if successful, Redhill Biopharma Ltd. will bring the data to the Food and Drug Administration for approval of RHB-104, and then Naser's technology and RHB-104 could possibly be readily accessible in local labs within five years.

If available to the public, patients will first get a blood sample taken at their doctor's office, which is then sent to a local lab where the blood's white blood cells are isolated and screened for DNA of the MAP pathogen. The information from the lab will be sent back to a doctor, who can then prescribe the patient with the either RHB-104 or an antibiotic to fit the patient's needs.

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