Date: Feb 28, 1993 Author: BRYAN HAY Source: Morning Call (
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Before the advent of antibiotic therapy, nutritional management and enzyme therapy, cystic fibrosis patients "were born with misery . . . lived with misery and . . . died with misery," said Dr. Tibor Sipos.
Even with advanced treatment, cystic fibrosis wrecks young lives, said Sipos, who is working at Lehigh University to commercialize a new drug that will help those who suffer from the disease.
About 30,000 Americans have cystic fibrosis, a genetic disease that affects Caucasians and devastates the lungs, drowning patients in their own secretions. Therapy often includes slapping the patient on the back to loosen the mucus.
The disease also strikes the pancreatic gland, bile duct, the liver and the intestine, which all get blocked by mucus -- or sludge -- as it's more widely called.
Twenty years ago, patients rarely reached their teens. Antibiotics and other treatment extended life expectancy to 19 in 1980; today the average age of survival is 28.
"But in spite of these improvements, as they live longer they develop more diseases. One of the major complications is the liver," Sipos said, explaining how patients also lack digestive enzymes and bile salts in the intestine.
Working out of the Ben Franklin Business Incubator, he launched Digestive Care Inc. last year to combat the disease, after spending 22 years in pharmaceutical research for Baxter Laboratories and Johnson & Johnson.
His new, potent drug, Digestizyme, can be delivered directly to the target site, something that's never been achieved before. Its bile acid ingredient, ursudiol, protects the liver from toxins, enhances bile flow, and clears sludge from the bile ducts.
It normalizes digestive functions, frees mucus from the intestine, and flushes the liver.
The compound, interestingly enough, came about from Oriental folklore. Asians attributed magical powers to the gall bladder and bile juices of the bear.
When a bear goes into hibernation, its metabolic rate slows down. One would think the bear would easily form gallstones, yet they never show up, Sipos explained.
Modern research has found that the bear has a beneficial bile acid called ursudiol. Human bile contains a small amount, maybe 5 percent, Sipos said. The bear has 60 percent, depending on its diet.
"It is believed that increased ursudiol prevents the formation of gallstones in the bear," Sipos said. Beyond its cystic fibrosis application, Sipos expects the drug to be used to treat liver disease and even prevent colon cancer.
"This new form of medication combines both pancreatic enzymes and this compound in its biologically active state," said Sipos.
The system is stabilized by placing it into microencapsulated form, which protects the drug as it moves through the digestive tract. This is a important, he said, because the drug can reach the liver and intestine and release its biological activity.
"That's where the great excitement about this lies. To date that has not been achieved."
Sipos, in collaboration with Lehigh chemistry professor Ned D. Heindel, is conducting animal studies, testing the drug's toxicity in rats, an FDA requirement. After six months of animal testing, the next step will be an Investigation of New Drug Application, a total characterization of how the medication works.
Then it will be tested in a simulated human intestine, to see how fast it dissolves under gastric conditions. It will eventually be tested in cystic fibrosis patients.
"This is why research takes so long and development is expensive," Sipos said. He has already piqued interest among major pharmaceutical companies, attracted $250,000 from the National Institute of Health and another $265,000 from the Ben Franklin program.
With all of its potential, Sipos is already calling his medication a wonder drug.
"I hate to say that, but that's what we find. We are sitting here on the forefront of this new form of medication," he said. "Because it's not available in its biological active state, we are very fortunate to have this."
He also feels strongly about erasing the complications of cystic fibrosis.
"I have a drive to solve this problem," he said. "It breaks my heart to see these little kids suffering. If I can contribute to their well-being and improve their quality of life I will do it."
