Quest for Better Medical Cleansing Agents Led to Hospital Hit

June 15, 2009 — One of the first challenges physicians face when patients are brought into the emergency room is cleansing their wounds of debris, a process made more painful by the products that are available for the task. Many of them, like hexachlorophene and iodine, are even toxic. They destroy healthy cells along with bacteria.

As director of the University of Virginia's Wound Healing Research Laboratory, George Rodeheaver was determined to find a biocompatible, water-soluble solution that could be used to clean wounds without doing more damage.

"The goal of our lab is to apply science to maximize the healing process," he said.

Rodeheaver set his sights on finding a surfactant – a wetting agent essential for cleaning agents – that was non-ionizing and that would not destroy healthy tissue. After extensive research, he developed a base formulation that was commercialized as Shur-Clens.

"I discovered a correlation between chemical structure and toxicity that led me to this surfactant," he said.

As a wound-cleaning agent, Shur-Clens is ideal. A physician can use it to flush debris out of a patient's eyes without causing pain or harming tissue.

Rodeheaver soon realized that his cleansing formula might have other applications. The products used by surgeons to treat burns and chronic wounds like bedsores also have their drawbacks. Because they are not truly water-soluble, they form a residue that interferes with the delivery of healing agents. This residue must be removed each time a dressing is changed, a process that causes additional pain and destroys new tissue.

Rodeheaver modified the formula for Shur-Clens to produce a stable gel. Not only is this gel water-soluble, but it also thickens at body temperature, making it the perfect vehicle for coating wounds and burns and delivering a variety of agents, including antibiotics.

Rodeheaver patented it as PluroGel. For the past 15 years, physicians at the University Medical Center have used PluroGel to carry antibiotics to burns and chronic wounds, dramatically reducing the incidence of infection among their patients and augmenting the healing process.

In 2008, Rodeheaver was named the Edlich-Henderson Inventor of the Year by the University of Virginia Patent Foundation for this work.

Because PluroGel as a carrier for antibiotics has not been approved by the FDA, it can be used only at the University. When Dr. Adam Katz joined the Department of Plastic Surgery as the director of the Chronic Wound Care Clinic, he was so impressed by PluroGel's value that he partnered with Rodeheaver to start a company, PluroGen Therapeutics Inc.

PluroGen's initial goal is to secure FDA approval for a topical antibiotic product based on PluroGel and make it widely available. They enlisted Neal Koller, a former pharmaceutical company executive, to serve as president and CEO.

In creating the company, Katz and Rodeheaver tapped into the T100 Alumni Mentoring Program, an initiative in the Office of the Vice President for Research that matches alumni business experts with emerging companies.

Through T100, PluroGen received mentoring and financial support to refine its business plan and build its network of relationships. Guidance from T100 was helpful in bringing Koller on board.

Starting a company like PluroGen often stimulates additional research. New companies actively seek out products that diversify their portfolio and increase their chance of success. At the same time, researchers see in these start-ups a vehicle to realize the full potential of their discoveries.

This has certainly been the case with PluroGen. Rodeheaver has been collaborating with former faculty member Dr. Cato Laurencin and his team to find new applications for PluroGel. They are combining PluroGel with nanocrystalline silver, an important antimicrobial; and with chitosan, a naturally occurring biocompatible material that makes PluroGel dressings last even longer. At the same time, Katz is working with PluroGel to deliver fat-derived stem cells to wounds to promote healing.

In the meantime, Koller focuses on keeping the company afloat by promoting the use of PluroGel for a variety of products that do not require FDA submission. For example, one of PluroGen's commercial partners has already introduced a line of skin and wound cleansing wipes that include

PluroGel. PluroGen is working with a number of other companies to develop products for additional new markets, including the retail, cosmetic and dermatology markets.

Who knows? The next generation of skin cream may have a PluroGel base.

— By Charlie Feigenoff

This story originally appeared in Explorations online.

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