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GeoPharma Will Develop Ovarian Cancer Screen Test

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By MICHAEL SASSO, The Tampa Tribune

Published: December 4, 2007

LARGO - A fledgling pharmaceutical company hopes to help thousands of women detect ovarian cancer, a disease that kills more than 15,000 women a year.

GeoPharma Inc. will begin developing a test that can detect ovarian cancer in its earliest stage. Up to now, pathologists typically have only detected the cancer in its later, deadlier stages - often too late to be cured.

When discovered in its initial stage, ovarian cancer can be cured 90 percent of the time, GeoPharma President Kotha Sekharam said. The company has licensed the technology and marketing rights for the test from the University of South Florida Research Foundation, a not-for-profit group that helps commercialize university research.

A USF researcher discovered that women who have ovarian cancer have elevated levels of a type of protein in their urine. The university got a patent on that discovery. The licensing deal could be a significant win for GeoPharma. It beat out several competitors for the licensing deal.

"This is an exciting technology, and it's not surprising that several companies would be interested in it," said Valerie McDevitt, USF director of patents and licensing. She declined to identify competitors or say how much GeoPharma is paying the university. McDevitt said the information is not subject to state public records laws.

The test got its start three years ago, when Patricia Kruk, an associate professor in USF's College of Medicine, began studying ways to detect ovarian cancer. Kruk discovered that a protein called "Bcl-2" is present in elevated levels in urine when a woman has ovarian cancer. Other researchers had discovered the same protein in ovarian cancer tumors, but no one made the connection to the disease and high levels of the protein in urine, Kruk said.

Important Discovery

The discovery is important because the existing ovarian cancer test looks for evidence of cancer in blood, and the cancer is often detected after it has spread out of the ovaries. In up to 75 percent of cases, the disease isn't found until the later stages, Kruk said.

Making matters worse, women often don't notice ovarian cancer symptoms because they can be common ailments, such as bloating and constipation, Kruk said.

Sekharam, GeoPharma president, said the company will begin developing a urine test that looks for elevated protein levels. USF has done clinical trials on patients, but the FDA may require the company to do more. Sekharam said he couldn't predict when the test might be publicly available.

If approved by the FDA, the company's initial target market will be physicians who suspect ovarian cancer in patients and will monitor the progression of the disease in women, rather than screening for the cancer. More than 22,000 women are diagnosed with the disease each year, Geo-Pharma says.

Many Lives Could Be Saved

Eventually, Sekharam hopes federal regulators will expand use of the test to become a general screening tool for the disease. The company estimates an effective early-testing device, such as a urine test, could save the lives of 14,000 of the 15,000 women who die of the disease yearly.

The test could be a milestone for publicly held GeoPharma. The company has been making nutritional supplements since its founding in 1994 and has been trying to develop into a generic pharmaceutical company in recent years. Last month, it announced its first FDA pharmaceutical approval, which cleared the way to produce a veterinary medicine for dogs.

The company's financial and stock performance has swung from year to year. For example, during its fiscal year ended March 31, it earned $2.5 million in profits on revenue of $59.8 million. In the first six months of this fiscal year it lost $2.7 million on revenue of $12.8 million. Revenue fell, in part, because it sold a pharmacy benefits management subsidiary. Its stock has traded in the $2 to $5 range for the past three years. It closed trading at $3.25 a share Monday on the Nasdaq Capital Market exchange.

Reporter Michael Sasso can be reached at (813) 259-7865 or

msasso@tampatrib.com.

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