“It’s about quality of life,” Prof. Joseph Katz, head of Bio-Med.Some 50 million people, including one in every two menopausal woman in America, are taking drugs to reduce the dangerous effects of osteoporosis. A little known fact is that a small percentage of these people will actually have the quality of their life diminished. Some are already suing drug companies in America over it.
An unfortunate side effect of taking medications from the bisphosphonate family – widely used to treat osteoporosis – is bone rot of the jaw, known in scientific terms as osteonecrosis. Basically, bone cells in the jaw start dying, weakening the bone.
About one percent of all people taking bisphosphonate drugs will develop osteonecrosis, which in the worst case can lead to severe infection and even death. Meanwhile, a higher percentage of people prescribed bisphosphonate drugs to stop bone re-absorption in prostate or breast cancer, are also at risk of serious bone rot of the jaw. Anywhere from three to nine percent of all people in this category are at risk.
Two sunny states unite for a solution
Help is around the corner. In 2006, Micromedic Technologies, an Israeli biotech company traded on the Tel Aviv Stock Exchange, started working with a University of Florida scientist to genetically screen people at risk for osteonecrosis. The new company, a Micromedic subsidiary called Bio-Med, now employs about 15 scientists and clinical staff in America. Based out of the University of Florida, the collaboration was a natural choice.
“David Solomon, the CEO of Micromedic Technologies is interested in biomarkers for screening different diseases and I knew he was interested in personalized medicine,” says Prof. Joseph Katz, from the College of Dentistry at the University of Florida, who heads Bio-Med. “The idea in our case was to find a way that patients could take a genetic test to see if they are susceptible to osteonecrosis.”
Katz is an Israeli scientist who trained at the Hebrew University in Jerusalem. He comes to Israel regularly for conferences and events. He tells ISRAEL21c: “Biphosphanates are given orally or by injection once a month to prevent osteoporosis. This story really bothers me because the population getting treated is very high.”
Taking biphosphanates is not problematic for the short term, says Katz. “If treated for only one year the chances are slim, but it gets more serious if someone is being treated for 10 years or the rest of their life. There’s a huge chance they will develop it.
Improving the quality of life
“This phenomenon is happening spontaneously. The area never heals and never gets better,” explains Katz, who spoke to ISRAEL21c while in Israel attending an Oral Oncology conference this month. “If there is a severe infection with sepsis the patient could die. It’s about the quality of life. We see in prostate cancer patients that these drugs are supposed to improve their quality of life, but instead it’s getting worse. They can’t chew, eat, or wear dentures.”
Bio-Med scientists at the university are now working on a blood-test kit that could be ready in as little as two years. Right now the company is in Phase I clinical trials, but if it gets United States Food and Drug Administration (FDA) approval, it could change the lives of people taking bisphosphonate-type drugs.
The discovery falls in an area of drug discovery called personalized medicine, an emerging industry that uses genetic profiling to determine the efficacy of drugs. Through biomarkers, Bio-Med hopes to identify which cancer patients, or those taking osteoporosis drugs will develop bone rot of the jaw.
Saving life-giving medications
A screening solution would be good news for the FDA as well, because very useful drugs are now susceptible to being pulled from pharmacy shelves due to increased lawsuits by people who have developed osteonecrosis.
Thanks to the work of Katz, who has identified what he believes to be the susceptibility to bone rot of the jaw gene, and with the commercial backing of Micromedic Technologies, this serious problem may be avoided.
Bio-Med believes its test could warn doctors anywhere from 50-70 percent of the time if a person is at risk for rot of the jawbone: “There are alternatives,” says Katz. “One could prescribe less potent drugs. There are also other medications that could be used.”
Bio-Med is also working on a second project: a biomarker that could be used as a screening test for oral cancer.