With the escalating incidence of wound-causing illnesses such as obesity and diabetes, compounded by aging populations, wound care is a serious health issue. Fortunately, significant progress is being made in elucidating the complex physiological processes involved in wound healing. New treatment options are entering clinical testing as biotechnology companies create innovative treatments designed to accelerate healing of wounds that result from diabetes, poor circulation, bed sores, burns and scarring from surgical procedures that can take weeks or months to heal.

Technologies using stems cells, growth factors and other regenerative medicine techniques are well positioned to create products that will make a dent in healthcare costs by reducing the amount of time patients have to remain in hospital.

Value Proposition

One area where the value proposition of new therapies will be clearly evident is in the acute wound repair and fibrosis space. With an estimated 235 million surgical procedures conducted worldwide annually, fibrosis or scar tissue occurs in 93 percent of these procedures.

AdeTherapeutics Inc., an emerging biotechnology company based in Saskatoon, Saskatchewan, has an anti-fibrosis platform and is applying it to many different areas of surgical procedures. It acquired the rights to Evitar, a formulation of a known dipeptide, from the University of Saskatchewan. The peptide can be administered at the time of surgery using a variety of delivery mechanisms. When administered locally during surgery the peptide activates the body's internal barrier repair system and accelerates the pace at which healing can take place.

"The company is taking a systems approach to wound healing," Sanj Singh, president and CEO, told BioWorld Insight. "Fibrosis is the end result of a series of events that occur after mechanical damage to the epithelium and/or endothelium. Although the etiology of tissue damage in different organ areas may vary, the reparative process that ensues is remarkably similar. Since fibrosis results from mechanisms that have gone awry we are trying to get the body to correct itself and our peptide is the enabler to bring about positive change."

The company recently initiated its first Phase I/II clinical trial for Evitar in gynecological laparoscopic surgeries.

Singh said the company is in the midst of a capital raise that he hopes will generate about $8 million to fund clinical development programs for the next three years.

One wound healing company that has attracted venture capital is Promedior Inc., of Malvern, Pa., which added $3 million to its Series D financing through a second closing, bringing the total raised to $24.5 million. Proceeds will be used to advance its pipeline products, particularly lead product PRM-151 (recombinant human Pentraxin-2) in pulmonary fibrosis, which recently completed a Phase Ib study. (See BioWorld Today, Oct. 16, 2012.)

Last year, SironRX Therapeutics Inc., a regenerative medicine spinoff from the Cleveland Clinic that is developing a topical therapy to accelerate dermal and bone healing and decrease scar formation, closed a $3.4 million Series A investment. (See BioWorld Today, Aug. 17, 2011.)

The company in-licensed its lead drug, JVS-100, for dermal and bone repair from Juventas Therapeutics Inc., another Cleveland Clinic spinoff pursuing another indication for JVS-100 in cardiovascular disease. JVS-100 contains an engineered version of stromal cell-derived factor 1 (SDF-1), a naturally occurring factor that activates the body's repair processes.

RNAi Technology

Also in the space is RXi Pharmaceuticals Corp., of Worcester, Mass., which has started Phase I trial testing RNAi compound RXI-109 using the firm's self-delivering RNAi technology. RXI-109 is designed to reduce or prevent skin scarring following trauma or surgery and is intended to reduce disfiguring hypertrophic scarring and keloids. (See BioWorld Today, June 27, 2012.)

Over the course of three months 15 subjects scheduled to undergo abdominoplasty were enrolled in the study during which single intradermal injections were administered in a dose dependent manner to five cohorts of three subjects each. Subjects received an injection of RXI-109 in two separate areas on the abdomen and placebo injections in two other areas of the abdomen. Data on safety and tolerance were collected and evaluated for each cohort before moving to the next cohort with a higher dose level. The company reported that RXI-109 was well tolerated by intradermal injection.

Sirnaomics Inc., of Gaithersburg, Md., said that it has been awarded a Small Business Innovation Research grant to support the development of its small interfering RNA (siRNA) therapeutic product STP705 to improve skin wound healing. The funding will allow the company to perfect its nanoparticle-based siRNA delivery systems and speed up investigational new drug application-enabling studies for the product. (See BioWorld Today, June 26, 2012.)

In addition to attracting venture capital, innovative biotech companies have attracted the attention of big pharma. For example, Excaliard Pharmaceuticals Inc., which generated positive Phase II data for its lead anti-scarring compound, EXC 001, designed to interrupt the process of fibrosis by inhibiting expression of connective tissue growth factor (CTGF), was acquired by Pfizer Inc. Overexpression of CTGF in response to damaged tissue following surgery or a traumatic injury is what leads to skin scarring.

Excaliard tested EXC 001 in patients undergoing a tummy tuck and in women undergoing elective revision of hypertrophic scars of the breast. Data showed that the compound demonstrated efficacy across the different scar types and surgical procedures, with no drug-related advents reported. (See BioWorld Today, Nov. 23, 2011.)

According to The Mattson Jack Group, an independent research group, the U.S. commercial market for reduction of scarring in the skin is valued at approximately $4 billion a year.

Editor's note: Next week, the second part of this article will examine other wound care strategies including the role of stem cells and regenerative medicine and the companies involved in their development.