July 25, 2006

FDA clears FirstString's path toward human testing

Sheila Watson  /  The Charleston Regional Business Journal

FirstString Research Inc., a biotechnology company marketing a wound-healing process created through research at the Medical University of South Carolina, has received Food and Drug Administration approval for human testing of its product after FSR completes specific animal testing trials.

The product deals with the skin's wound repair process using a bioengineered peptide, 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 developed by Rob Gourdie, a professor of cell biology at MUSC and a Clemson professor of bioengineering, and MUSC post-doctoral fellow Gautam Ghatnekar.

"We thought it might be classified as a drug, which usually means seven to 10 years or even longer for testing," said Don Olson, chief executive officer of FSR. "But because we're topical and not ingested, it's a much lower risk. So our path could be down into the three-year range."

The company met with the FDA for one hour on July 12 to discuss protocol and work out details to proceed to phase-one human safety studies, which are expected to begin in the first quarter of 2007. The product should be on the market within three years after the human studies.

FSR has been testing on pigs since February, starting with two pigs and adding five more in July. Ghatnekar and Michael Swindle, a professor and chair of the Department of Comparative Medicine at MUSC, are conducting the ongoing pig trials. The FDA is requiring another test with 24 pigs. "We have to do some more animal studies, but at least the test is well-defined," he said.

The 24-pig trial is comprised of three groups of pigs - one group with excisions but no treatment, one with excisions treated with the gel that serves as a carrier for the peptide and one with excisions treated with the gel and peptide. Each group will contain four males and four females. "It's clearly delineated that's what they want," he said. "It helps to have a specific definition."

In addition, the tests must be performed under GLP, or good laboratory practices, which Olson said is the standardized method for documenting the tests. "These requirements are expensive," Olson said, noting that the 24-pig test will cost more than $100,000.

In order to make the technology available on the market, FirstString Research Inc. was formed as a biotechnology, tissue engineering and development company in December 2005, with assistance from MUSC's Foundation for Research Development, which helps develop university-based technology for business use. Ghatnekar and Gourdie serve as president and chief scientific officer, respectively. After incorporating, the company applied for both U.S. and international patents.

Early experiments in vitro and on mice showed encouraging results, which propelled the company into large-animal trials to continue to evaluate the technology. Pigs are used for testing because a pig's skin is similar to human skin, Gourdie said.

FSR was the first company in the Charleston area to be brought into the South Carolina Research Authority's SC Launch! program. FSR's offices are located in the SCRA's Trident Research Center.

Human trials will determine the peptide's efficacy in humans and its introduction into the marketplace for use by physicians. The company would like to have a product in the hands of plastic surgeons within two or three years, "not just for cosmetic purposes, but also for burns and diabetic wounds," Olson said.

Other uses could include organ tissue regeneration. The peptide already is being tested in heart-injury experiments in Gourdie's laboratory. Currently, there are no mechanically based products approved by the FDA that can reduce or eliminate scarring and promote wound regeneration.

FSR was created as an investment-grade company by design, Olson said. "I know the numbers Johnson & Johnson or Merck would want, and we're working toward that goal within five years."

In addition to beginning the FDA-required animal testing, the company is also exploring the possibility of testing in Europe to see if that might get the product to market sooner. "We have an obligation to our investors to find the fastest path to market," Olson said.