Newspaper article The Florida Times Union

Area Company Is Stomping at Starting Gate of Success Ponte Vedra Beach-Based Copharos Gets FDA Approval for Clinical Trials and More Funding

Newspaper article The Florida Times Union

Area Company Is Stomping at Starting Gate of Success Ponte Vedra Beach-Based Copharos Gets FDA Approval for Clinical Trials and More Funding

Article excerpt

Byline: Sarah Skidmore, Times-Union business writer

It's not California, and it's certainly not Kentucky. But a local start-up company has trotted into the biopharmaceutical race with recent approval by the U.S. Food and Drug Administration to develop its cancer detection compound.

"In this business, the most important point is when you start human trials," said Stefan Borg, president and chief executive of Copharos Inc. "It's like at the horse races when they open the gates and they're off."

Biopharmaceutical companies typically flock to areas less like Jacksonville and more like California, which has rapid access to established medical research facilities, investors and other institutions that can speed along their product development. Yet employees at Copharos in Ponte Vedra Beach have smoothly launched a product that will soon start clinical trials.

The company started in August 2000 and recently gained FDA approval for its investigational new drug application, which is required to apply for clinical trials. Copharos needed the initial FDA approval to secure an additional $2.5 million in capital funding from its investors. Trials will begin this month.

Getting to this point completes the initial venture financing round, but the company will need at least an additional $20 million over the next three years to advance the company to the point where its product could reach the market.

Like any start-up after a major milestone, Copharos is using its initial success to attract more investors and will begin its second round of financing by the middle of the year. But the company is primarily focused on the trials, which it plans on beginning in New York this month and in Tampa by March or April.

The company arranged for State University-Buffalo and The Moffitt Cancer Center in Tampa to run trials of an altered vitamin B-12, based on research work developed at the Mayo Clinic in Rochester, Minn.

Douglas Collins, a diagnostic radiologist at Mayo, worked with his former professor and biochemist Harry Hogenkamp of the University of Minnesota to create the patented compound Copharos is commercializing.

The compound bonds vitamin B-12 with a radioisotope regularly used for diagnostic imaging. The altered vitamin is injected into a patient and picked up by cells where its presence can be detected by a common imaging camera used in nuclear medicine. Because there is little to obstruct the view in imaging the chest area, the company is initially investigating its usefulness in detecting breast and lung cancers.

All living cells require this vitamin, but rapidly dividing cells, such as cancerous cells, require more of the vitamin. By finding areas in the body with an abnormally high presence of vitamin B-12, possible cancerous developments can be detected.

Borg refers to the technology as a Trojan horse that sneaks inside the cell because the body rapidly accepts it as normal vitamin B-12 even though it has this agent bonded to it.

There are traditional methods for detection and diagnosis of cancers, but the company is focusing on two cancers where it sees the largest opportunity exists to aid patients and practitioners with another tool for detection.

For breast cancer, common self-examination and mammography are still recommended. …

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