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Wound-Repair Gel Approaches Market |
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Shelia Watson, Charleston Regional Business Journal
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Wednesday, 28 November 2007 |
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FirstString Research Inc., a Charleston-based biotechnology company developing a wound-healing process, is ready to move into its clinical trial stage, which will include testing its product on humans.
“We’ll begin our phase-one clinical trials early next year,” said Gautam Ghatnekar, president of FirstString and one of the developers of the process with Rob Gourdie, a professor of cell biology at Medical University of South Carolina and a Clemson University professor of bioengineering. In that early stage trial, the product or drug candidate is tested on very small groups to evaluate dosage, administration and safety.
The research and testing deals with the wound repair process in the skin using a bioengineered peptide, which is based on a naturally occurring protein in the body that helps regulate communication between cells to accelerate wound healing and tissue regeneration with significantly reduced scarring.
The process was created through research at the Medical University of South Carolina. To make the technology available on the open market, FirstString was formed as a biotechnology, tissue engineering and development company with assistance from MUSC’s Foundation for Research Development, which helps university-based technology for business use.
Last year the company met with the Food and Drug Administration and received approval for human testing of its product after the company completed animal testing trials.
Ghatnekar explained that because the drug is a topical gel, the FDA approval process is somewhat less stringent than it is for drugs that are ingested.
“With this type of drug, you don’t have to worry about where the drug is traveling to in the body,” he said. “So far in all of our testing, there have been no adverse reactions.”
Even before testing was completed, the company began to receive accolades. At the recent conference with Southeast BIO, the company was selected out of a group of 60 to present its business case before a panel of venture capitalists. SEBIO is a regional nonprofit organization that fosters growth of the life sciences industry in the Southeast United States.
“We were the first South Carolina biotech company to be a finalist for this event,” said CEO Spencer Robert. “What this did is put us before interested investors and industry-experienced entrepreneurs who may be interested in helping us and providing support.”
Ghatnekar said one thing that impressed investors at SEBIO was the amount of money the company has raised even in this early stage. To date that amounts to $2 million in private funds plus a $100,000 National Institutes of Health grant with matching funds from the South Carolina Research Authority’s SC Launch! program. The NIH grant and matching funds will be used to test the company’s product on chronic wounds, such as diabetic ulcers, as well as to test its ability to reduce scars.
Robert said the upcoming clinical testing on humans, expected to last about six months, will move the company closer to full FDA approval for the topical wound-healing gel as well as other products in the works.
“This is the first of many drugs that we’re developing,” he said. “We have others in the pipeline. Some are used for internal applications like cardiac injuries and spinal cord injuries and cancer.”
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