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Local drug maker takes big step

11-Jan-2009: A locally based upstart pharmaceutical business is about to take a big step with its first drug candidate.

Charleston Laboratories Inc. expects to begin today the first human clinical trials on what it is calls CL-108, which is formulated to significantly reduce two unsavory side effects of certain narcotic painkillers - nausea and vomiting.

"After many months' development in the lab ... it is ready for testing in man," said Dr. Bernard Schachtel, chief medical officer at Charleston Laboratories.

Paul Bosse, a former pharmaceutical sales representative and the company's chief executive officer, said the market is large - and largely untapped - for an anti-nausea agent that can be combined with an already- approved painkiller. Right now, patients must take a separate drug to offset the sickening side effects.

"It's a big problem with pain," Bosse said Friday.

The testing will be held in Texas. The company expects to the results, which will be submitted to the Food and Drug Administration, by the end of February.

Charleston Laboratories was incorporated about a year ago, and Bosse has been working with a small team of scientists, all experts in pain remedies, he said.

"We're all very much interested at the end of the day of putting quality drugs on the market that will benefit patients," he said.

Once the clinical trial is completed, Charleston Laboratories will launch "a phase-three efficacy study, which going to be very large," Bosse said.

The downtown-based firm is privately financed. Just last week, it announced it lined up an undisclosed amount of new capital to fund the CL-108 project by selling preferred stock. If all goes well, Bosse said, the Gadsen Street company will likely seek out a partner from Big Pharma to bring its "fast-dissolving, low-dose" tablet to market.

"We're hoping to get approval of this drug in late 2010 or the first quarter of 2011," he said.

Source: Charleston Post Courier, SC

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