A promising pharmaceutical approach to scar treatment

Dr. Ferguson, is not only a professor in Manchester, but also chief executive officer of Renovo Ltd. a pharmaceutical company that has raised more than $59 million to develop scar healing products.

He and his colleagues reasoned that rapid intervention with appropriate growth factors might prevent cells from initiating the signalling cascade that leads to wound healing by the scarring pathway.

"Wounding" by surgical incision is a planned event that occurs under controlled conditions, and wounds that result from major trauma, such as automobile accidents, are normally treated soon after the occurrence. Researchers hypothesized that therapeutic intervention within the first 24 or 48 hours could alter the local environment in a way that favors the scarless healing pathway.

"The first triggers for wound healing and scarring come from growth factors released by degranulating platelets and inflammatory cells," Dr. Ferguson says. "These released growth factors set off auto-inductive, auto-catalytic cascades, which after a couple of days have induced so many other cellular and molecular responses that the cascades are functionally redundant and highly interactive."

At Renovo Ltd., co-founded by Dr. Ferguson, three products are in clinical development for prevention of scar formation.

"Our therapeutic manipulations of adult wound healing, to prevent or reduce scarring, focus on elevating the levels of TGF-Beta3 or preventing the activation of TGF-Beta1 and TGF-Beta2 or modulating the inflammatory response," Dr. Ferguson says. "In other words, we make the adult wound environment more like that of an embryonic wound."

The lead candidate is Juvista, human recombinant TGF-Beta3 for intradermal injection at the wound site, which is in phase 2 clinical development for scar prevention. A compound under development for scar improvement is Juvidex, a sterile solution of mannose-6-phosphate for intradermal injection at a wound site. As a modulator of the inflammatory response, Prevascar (human recombinant IL-10) is under development as a therapeutic agent to reduce scarring.

As of 2007 some of these new drugs have successfully completed safety and other studies, such that they have entered human clinical trials with approval from the appropriate regulatory authorities. Initial trials involve application of the drug or placebo in a double-blind randomized design, to experimental incision or punch biopsy wounds under the arms of human volunteers. Based on encouraging results from such human volunteer studies, the lead drugs have now entered human patient-based trials e.g. in skin graft donor sites.

This means that scarring may no longer be an inevitable consequence of modern injury or surgery and that a completely new pharmaceutical approach to the prevention of human scarring is now possible. Scarring after injury occurs in many tissues in addition to the skin.

Thus scar-improving drugs could have widespread benefits and prevent complications in several tissues, e.g. prevention of blindness after scarring due to eye injury, facilitation of neuronal reconnections in the central and peripheral nervous system by the elimination of glial scarring, restitution of normal gut and reproductive function by preventing strictures and adhesions after injury to the gastrointestinal or reproductive systems, and restoration of locomotor function by preventing scarring in tendons and ligaments.

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