Chattanooga physician David Adair maxed out credit cards, sold his grandfather's watch and worked 20 years to pursue his dream of developing an effective drug to a sometimes-deadly disease of pregnancy.
Last week, he came one step closer when the Federal Drug Administration gave the "orphan-drug" designation to his treatment for severe preeclampsia and eclampsia, allowing him to apply for grant funding.
The designation also gives his company exclusive marketing rights for up to seven years and fast-tracks the FDA review process.
"I've seen patients die -- both moms and babies -- with this disease," said Adair, a high-risk obstetrician who established a biotech company to work on the medicine. "This was the opportunity I saw to bring something good and right to my patients."
Preeclampsia, a condition in which a pregnant woman develops extremely high blood pressure, is one of the leading causes of death for mothers and babies worldwide. Even if both the mother and baby survive, it results in thousands of premature births annually. Eclampsia is a complication of preeclampsia with such symptoms as seizures, brain damage and comas.
Adair began his preeclampsia research in 1992, using a compound called digoxin immune fab (ovine). Known as Digibind or Digifab, it is used to treat cardiovascular disease.
He found some research showing the drug may remove toxins which cause preeclampsia. There is no definite diagnostic test for preeclampsia, and the only treatment is to try to lower the high blood pressure or to end the pregnancy.
Digibind would be the first drug actually to treat the disease rather than the symptoms, Adair said.
His research and clinical trials show about 80 percent of women suffering from severe preeclampsia and eclampsia respond to the drug.
He spent years doing scientific research and has conducted two clinical trials using the drug. Along the way, he established Glenveigh Medical Co., the company through which he has researched the drug treatment.
"I was single and childless, now I'm married and have three kids and one is getting ready to go to college," Adair said.
Adair still remembers the first time he truly believed Digibind could work on preeclampsia. He was living in North Carolina at the time, and a doctor who knew about his research called him.
The doctor had a patient who had developed preeclampsia when she was 20 weeks pregnant with twins. The doctor believed the only way to save her was to end the pregnancy, but the woman didn't want to do that.
Adair said he first called his priest to pray about the decision.
"I told him, 'I'm giving this medicine and the worst thing that can happen is I can kill her,'" Adair remembered. "But I felt peace in my heart so I went in and started the administration."
The woman got better.
"I knew then I was going to pursue this, that this was put there for me to champion," he said.
The FDA designation is one more step for the project to move toward being approved for clinical use, he said.
The FDA created the Office of Orphan Products Development in 1983 to provide incentives for researchers to develop products for rare diseases that affect fewer than 200,000 people. The program has enabled the development and marketing of more than 350 drugs and biologic products for rare diseases out of more than 3,000 applications, according to the FDA's website.
Richard Proctor, CEO of Glenveigh, said he and Adair hope a larger company will help conduct a third clinical trial and do the final work necessary to get the drug on the market.
With the latest FDA approval, that step could come as soon as 2015, Proctor said.
Research on treatment for preeclampsia is sorely needed, said Eleni Tsigas, executive director for the Preeclampsia Foundation.
"We do not have any therapeutic intervention at this point; there is even hardly anything to treat the symptoms," Tsigas said. "It's really discouraging to see something we've been struggling with for 2,000 years and still don't have anything to halt or reverse the course of the disease."