More information is available as research develops at www.unthsc.edu/research/
Relief from the symptoms of menopause could be on the horizon thanks to groundbreaking research at the University of North Texas Health Science Center.
Hard at work are Dr. Laszlo Prokai and a research team determined to introduce the first treatment for hot flashes and other menopause symptoms since Premarin went on the market in 1942.
“I was the lead [researcher] on the team that discovered this molecule and family of molecules, these properties that expose estrogen only to the brain and leave the rest of the body unexposed,” said Prokai, a professor at the university’s Center for Neuroscience Discovery.
Isolating estrogen conversion to the brain is critical in minimizing or doing away with the life-threatening risks of hormone replacement therapy, Prokai said. The medication he and his team are developing allows the brain to metabolize the drug DHED into estrogen. The rest of the body does not recognize the drug, which is critical in sparing those areas potentially lethal side effects. Though untested in humans and not yet approved by regulatory agencies, DHED could offer hope for millions of women suffering from hot flashes, depression, impaired cognition and other neurological and psychiatric symptoms due to estrogen deprivation during menopause, according to Prokai’s research.
The professor began pursuing the drug 15 years ago while he was an assistant professor in the Department of Pharmaceutics and the Center for Drug Discovery of the College of Pharmacy at the University of Florida.
He was subsequently hired as the chairman for biochemistry at UNT Health Science Center.
After conceiving his hypothesis of estrogen conversion occurring only in the brain, Prokai began pursuing that goal. With $4.2 million in funding from the National Institutes of Health and other sources, Prokai developed DHED.
Along the way, he secured several patents as key steps in research were achieved.
“Altogether, we have a portfolio of five patents,” said Prokai. He said he is determined to secure federal approval for a drug that would dramatically change how hot flashes and other menopausal symptoms are treated.
Until 2002, many women took hormone replacement therapy, mainly progestin and estrogen, to reduce hot flashes. But clinical trials in that year determined that cancer and other life-threatening risks could result from hormone therapies based on the estrogen derived from pregnant mares’ urine – Premarin.
Following those clinical trials, collectively known as the Women’s Health Initiative, many women stopped taking the hormones.
“That therapy is still used, but women are advised to take the smallest dose for the shortest period to avoid risks,” Prokai said.
Fueling Prokai’s research has been the realization that women have few alternative treatments. He hopes to create an alternative that will become the leading form of treatment.
“Believe it or not, we are still relying mainly on something that was introduced to market in 1942. That’s Premarin. We can do better,” Prokai said.
But the road to relief could be rough. Drug companies tend to be more conservative and enter into developing pharmaceuticals only after phase one clinical trials have been successful.
That led Prokai to start AgyPharma LLC, his own start-up company dedicated to bringing his product to market. Up to $10 million may be needed to conduct clinical trials and other requirements for the drug, Prokai said.
“I put together the start-up company to move this from batch to bedside and to clinical trials,” Prokai said.