Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News
Graying Populations, New Technologies Driving Demand for Nonsurgical Products
New technologies and a graying population in North America and Europe are expected to drive the market for nonsurgical “bioactive” wound care products over the next five years. A Marketsandmarkets.com report noted that the global wound care market is expected to reach $18.3 billion by 2019 from $15.6 billion in 2014, growing at a CAGR of 3.2% from 2014 to 2019.
The growing senior population is a key factor in that projected growth, since it is most susceptible to skin wounds and chronic diseases such as cancer and diabetes, the report found. However, the Asia-Pacific region is expected to see the fastest growth in use of product due to its overall rising population, demand for more advanced healthcare, and increasing disposable income.
Following is a roundup of recent news and developments from five bioactive wound care product developers about new treatments either launched or in later clinical development phases.
Derma Sciences (Princeton, NJ) is in pivotal Phase III and IIIb studies for DSC127 (aclerastide), a patented peptide analog of angiotensin II, as a potential treatment for accelerated treatment of diabetic foot ulcers (DFUs). Studies consist of STRIDE 1, which compares DSC127 with vehicle (gel without active ingredient); and STRIDE 2, which additionally compares DSC127 with standard-of-care gel as well as vehicle. Primary endpoint for both studies is complete wound closure by 10 weeks, confirmed two weeks later, after initiation of treatment. The estimated completion date for the studies is June 2016.
DSC127, also known as NorLeu3-A(1-7), is designed to accelerate and normalize the healing and closure of dermal injuries while removing all vasoactive effects of the protein or peptide in humans and multiple animal models. In preclinical studies, DSC127 was shown to accelerate dermal tissue repair by increasing keratinocyte proliferation, extracellular matrix production, and vascularization. In Phase I and II clinical trials, aclerastide increased the incidence of full closure of DFUs. Aclerastide is also in preclinical development for the prevention and reduction of scarring after surgical incision and wound closure.
Macrocure (Petach Tikva, Israel) expects in October to report top-line study results from its Phase III clinical trial of CureXcell®, the company's lead product candidate for DFUs, spokesman Amiad Finkelthal told GEN. Designed to treat chronic and hard-to-heal wounds, CureXcell is a cell suspension containing a mixture of white blood cells activated through Macrocure’s hypo-osmotic shock cell activation technology, a process in which the concentration and pH of the suspension surrounding the cells is changed. According to Macrocure, CureXcell addresses each phase of healing in the impaired wound, including the production of growth factors and other biochemical factors involved in fibroblast activation, cell migration and extracellular matrix production, stimulating the body's natural healing process.
The DFU trial is one of two pivotal studies Macrocure has conducted for CureXcell. The company acknowledged over the summer that the other Phase III trial (MC-105) for venous leg ulcers (VLU) is not expected to meet its primary endpoint, based on a prespecified, futility analysis conducted by the trial’s data safety monitoring board. Nissim Mashiach, Macrocure’s president and CEO, said in a statement at the time that the company will evaluate data collected in the MC-105 study to determine an appropriate course of action, including a possible launch of a third Phase III study in patients with chronic wounds below the knee. That evaluation was still in progress at deadline.
In addition to preparing for a Biologics License Application to the FDA, Macrocure says it is also taking initial steps toward commercializing CureXcell. In August, New Jersey’s Economic Development Authority awarded Macrocure “Grow NJ” tax credits worth up to $3.2 million over 10 years to establish a North American headquarters and base 48 jobs at the EDA’s Technology Center of New Jersey in North Brunswick. “Macrocure is planning to open a commercial manufacturing facility in New Jersey,” Finkelthal said. The company at deadline had not confirmed additional details.
MediWound (Yavne, Israel) has completed enrollment in its second Phase II clinical trial to evaluate its EscharEx® biopharmaceutical. Based on MediWound's proteolytic enzyme technology, EscharEx is designed for removal or debridement of eschar in chronic and other hard-to-heal wounds. The randomized, controlled, assessor-blinded Phase II trial of 73 patients was conducted at 15 clinical sites in Israel and Europe and evaluated the safety and efficacy of EscharEx compared with gel vehicle for the treatment of a variety of chronic and hard-to-heal wounds. Such wounds include DFUs, VLUs, and post-surgical or traumatic hard-to-heal wounds.
The study’s primary endpoint assessed incidence of debridement, while secondary endpoints included wound bed preparation, wound healing and other additional efficacy and safety endpoints.
“The time frame for top line results from the Phase II study are still on track for around year end 2015,” MediWound spokeswoman Anne Marie Fields told GEN. “The company will determine designs and plans for a Phase III study of EscharEx to treat chronic and hard-to-heal wounds following the results from the Phase II study.”
MediWound is also continuing a Phase III study evaluating the effectiveness of its topically administered drug NexoBrid™ in removing eschar in deep partial- and full thickness burns—the same indication for which the product has E.U. approval, and has been commercially launched in the E.U. and Israel. Israel’s Office of the Chief Scientist is supporting development of NexoBrid and EscharEx through a $1 million grant awarded in June.
MiMedx Group (Marietta, GA) is commercializing its third biomaterial platform technology, CollaFix™, following publication in May of a study in the Journal of Tissue Engineering and Regenerative Medicine. CollaFix is a collagen-fiber scaffold created by wet spinning sub-millimeter fibers from purified soluble collagen, then crosslinking the fibers. The study showed that CollaFix showed sufficient strength and stiffness to promote fibroblastic differentiation of mesenchymal stem cells as well as substantial extra-cellular matrix production.
As a result, according to MiMedx, CollaFix represents a promising therapeutic approach as alternative tissue grafts for people with tendon and ligament injuries caused by trauma or continuous overuse. After rupture, many patients require tendon/ligament replacements to recover normal activity. Yet traditional replacement materials used for tendon/ligament surgeries have shortcomings that include donor site morbidity, risk of disease transmission and a high rate of long-term failure.
Organogenesis (Canton, MA) in July launched its PuraPly™ wound management products at the American Podiatric Medical Association annual scientific meeting, held in Orlando, FL. The products include PuraPly and PuraPly Antimicrobial (PuraPly AM), the first FDA-cleared purified collagen matrix with polyhexamethylene biguanide hydrochloride (PHMB) antimicrobial agent. PuraPly comprises layers of inherently strong, purified and biocompatible natural collagen matrix. By combining purified collagen with PHMB, Organogenesis said, PuraPly AM is designed to provide broad antimicrobial coverage, protecting against a wide range of bacteria that colonize wounds and can progress to biofilm formation and infection.
PuraPly and PuraPly AM are freeze-dried, porcine-based, and 100% type 1 collagen. Both products are approved for acute and chronic wound management across a variety of wound types, including partial- and full-thickness wounds, pressure ulcers, surgical wounds, trauma wounds, venous and diabetic ulcers.