CHARLESTOWN, S.C., Feb. 1 First-String Research, Inc. (FSR), a spin-off biotechnology company from the Medical University of South Carolina (MUSC), has begun the human clinical trial process for its unique, wound-healing peptide gel. Already past the preliminary approval stages, the "First in Man" trial will take place in Switzerland thanks to the assertive attention of Swiss investors. Initial preclinical studies have suggested the gel's efficacy and safety in regenerating new tissue, instead of scar tissue, in order to heal wounds better and faster than any product currently on the market.
In the clinical trial, four different doses of the gel will be administered to study participants with deep wounds. Those wounds will be examined periodically, and positive results from the study could put FSR's wound-healing gel one step closer to FDA approval. Currently, there are no mechanistically-based products approved by the FDA that can reduce or eliminate scarring and promote wound regeneration. "We have received an enormous amount of positive feedback from the investment community at large, including industry experts who were astonished at what we were able to achieve with such little funding," said Gautam Ghatnekar, Ph.D., FSR President and co-inventor of the gel peptide. "This product truly marks a paradigm shift from healing with a disfiguring scar to encouraging normal tissue regeneration."
It was in the lab of Robert Gourdie, Ph.D., MUSC professor of cell biology and Clemson professor of bioengineering, that the original peptide was created. Now on the FSR board of directors, Gourdie remains excited about the potential of technology he co-invented with Ghatnekar. "This peptide has tremendous potential in all body situations that involve healing because it regulates and modifies intercellular communication at the site of the wound," he said.
Since the company began a few years ago, FSR has been pleasantly surprised by the feedback from the investment community concerning its product.
Recently, FSR was chosen as one of four finalists among 40 companies that competed for the chance to present their work to the investment community across the Southeast during the Southeast Biotechnology Forum (SEBIO).
"SEBIO is the premier venue in the Southeast for young life sciences companies to test their marketability, and as such, we are privileged to have been selected as a finalist," said FSR CEO Spencer Robert. "We went through multiple review processes, each conducted by a mixture of successful entrepreneurs, venture capitalists and other industry experts. The publicity and interest we received from the event was invaluable. Our secret is definitely out."
Additionally, FSR is collaborating with MUSC on a National Institutes of Health-National Institute of Diabetic Digestive Kidney Diseases grant to study the peptide in treating diabetic wounds. The two entities are also working together on examining the peptide's efficacy in treating spinal cord injuries. This work is in the preliminary stages and has not yet progressed to clinical trials. The Office of Naval Research has also expressed interest in FSR's technology, which may be used to develop projects that will look at how the peptides could be used to treat injured soldiers on the battlefield.
How it works: The skin's wound repair process is initiated immediately after injury and involves inflammation, proliferation, scar production, and tissue remodeling. One of the common complications in wound healing is excessive scarring. Gourdie and Ghatnekar developed the bioengineered peptide based on a naturally occurring protein in the body that helps regulate communication between cells. This peptide accelerated wound healing and tissue regeneration with significantly reduced scarring in laboratory animal tests, and leads researchers to believ