Awardees, Research, Stories

Astounding Results In Wound Healing

CytoSolv
Providence, Rhode Island

Growth factors generated huge attention in the 1980s, when the Nobel was awarded to the team that discovered EGF, epidermal growth factor. Scientists already suspected growth factors harbored extraordinary healing properties, but with news of the Nobel, business suddenly became interested in the field. Abundant venture capital became available to endeavors employing the “new discovery.” However, less came of the opportunity than scientists — or investors — had hoped. Investment capital receded, leaving behind a few innovative applications for growth factors, including one for the treatment of diabetic ulcers (such wounds have many layers of disease and need extra help with healing). Sadly, the few growth factor-based drugs for diabetic ulcers that are on the market demonstrate faint success in aiding healing.

Happily, a STAC award-winning team of academics and scientists from CytoSolv, a small Providence biotech start-up, is working on a new growth factor-based treatment for diabetic ulcers, and their results appear significantly more promising. The collaborative team includes Brown University Professor Dr. Kim Boekelheide; CytoSolv Vice-President of Research and Development, Dr. Chris Thanos; CytoSolv bioengineer Briannan Bintz; and Dr. Moses Goddard, CytoSolv CEO.

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CytoSolv Collaborative Team: Chris Thanos, Moses Goddard, Kim Boekelheide and Briannan Bintz. Photo by: RI STAC

The $199,997 award was granted in February 2011 by the Rhode Island Science and Technology Advisory Council. The award supports the project’s Phase 1 research, which is focused on how to best deliver the project’s growth factor-based, super-healing drug to diabetic wounds using commercially available and company-formulated bandages.

Currently, commercially available, growth factor-based drugs for diabetic foot ulcers employ only a single growth factor. CytoSolv’s advancement involves a cocktail of naturally occurring growth factors. This exciting innovation is the brainchild of Thanos, and was developed from observations made by Thanos and Bintz during research on a rare breed of pig from the Auckland Islands. The breed is distinguished by its “purity”: it lacks many of the viruses commonly found in other pig breeds. Working with choroid plexus tissue from these pigs (the choroid plexus is the epithelial organ that makes cerebrospinal fluid), the researchers noticed that proteins derived from the tissue demonstrated exceptional regeneration and healing properties. The fact was not lost on Bintz or Thanos, who reports, “We quickly made the link that it would be good for wound healing.”

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Choroid Plexus cells in culture. Photo by: RI STAC

When compared with diabetic ulcer drugs currently on the market, the CytoSolv cocktail demonstrates genuinely astounding results. Its naturally occurring growth factors appear to speed and improve healing at rates more than triple the rate of its commercially available competitors. The researchers explain that its efficacy has to do with the cocktail’s ability to interact in multiple biological pathways for purposes of regeneration. In addition to superior healing abilities, the CytoSolv protein mix requires much smaller doses than commercially available solutions, which can have toxic side effects in large doses.

In 2009, the time came for Thanos and Bintz to assemble a business plan. They needed help. Thanos, a graduate of Brown University, sought it from his former mentor, Brown University Professor of Surgery Dr. Moses Goddard. Dr. Goddard’s extensive experience with biotech start-ups made him a logical choice.

Goddard believes that early start-up research needs to be done independently, away from the influence of private interests. He says that the STAC grant has been a crucial factor in enabling the collaborative team to do the major, upfront work on their own, allowing them to test what they believe to be “the right approach.” He explains: “The goal is to not have to bring in private investment until we reach the clinical trial period.” Goddard and the rest of the CytoSolv team feel strongly that STAC’s support has allowed them to maintain the integrity of their venture without giving up their plan for growing a promising, Rhode Island-based business.

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Briannan Bintz demonstrates how the treatment can be formulated into either a gel or a solid bandage. Photo by: RI STAC

“The STAC grant came at a critical time, and was profoundly important as part of a credible team of funding sources,” says Goddard. By helping to establish CytoSolv’s legitimacy, the STAC award helped the company secure additional financial support. The company cites the National Science Foundation as an example. The NSF looked at the STAC award as state support, which allowed CytoSolv to qualify for a higher rate of federal funding.

CytoSolv’s formulation shows promise in other health care areas, such as pediatric skin graft healing, and cosmetic applications, but at present its targeted benefactor is diabetic foot ulcers. The researchers are working with commercially available bandages, trying to determine a reliable, easily reproducible method of delivering the healing protein mix to skin ulcers.

The work is progressing at a deliberate pace. At this point, the company predicts clinical trials within a few years, and a move to market in approximately five years — and believes a sizable investment could move up those goal dates. For now, empowered by their STAC award, the CytoSolv team continues to gather strong data confirming the exceptional healing properties of their formulation.