Recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB), also known as becaplermin, is a well-established human therapeutic protein that holds promise for treating DFUs. rhPDGF-BB is a synthetic copy of natural PDGF that is a key initiator of the natural wound healing cascade. rhPDGF-BB is an active component of three approved therapeutics – Regranex® Gel, GEM 21S®, and Augment® Bone Graft (approval pending in U.S.).
We use a biocompatible, resorbable wound dressing to effectively deliver the rhPDGF-BB to the wound site and simultaneously provide a matrix for new cell and tissue ingrowth. The collagen matrix not only provides a matrix for cell ingrowth, but it also absorbs proteases in chronic wound fluid that are detrimental to wound healing. rhPDGF is more effective during the early phases of wound healing, causing an immediate influx of wound healing cells and new blood vessels that lead to more rapid healing.
In short, ABSOLVE® overcomes the limitations of an earlier generation product by providing for: Weekly (or less frequent) dosing instead of daily dosing, making it easier for patients to use the product and thus achieve better outcomes; fewer doses and shorter dosing duration, further helping patients use the product correctly and potentially improving safety.
Our first provisional patent application was filed in October 2014 (Serial #62/063,793). The invention provides methods and compositions for treating or promoting the healing of a wound, such as lower extremity ulcers in a diabetic patient, venous stasis ulcers, pressure ulcers, severe burns and large surgical wounds such as abdominoplasties and other types of surgical tissue flaps. The invention covers improved formulations of rhPDGF-BB that include 1) a carrier that facilitates maintaining an effective PDGF dosage at a wound site; 2) simultaneously provide a substrate for cell and vascular ingrowth; 3) is sterile and therefore safer; 4) facilitates better patient compliance because it does not have to be refrigerated and is only applied about once every other week; 5) has rhPDGF present at a higher concentration than prior art formulations; and 6) contains a more potent rhPDGF-BB formulation with fewer isoforms than prior art formulations.
Regranex® CMC gel is non-sterile and does not: provide a scaffold for cell growth, inactivate proteases, serve to sustain the release of the rhPDGF. Must be stored at 2-8° and applied daily for 5 months.
rhPDGF is applied once every 7-14 days at higher doses over 6 weeks causing faster influx of wound healing cells and new blood vessels.
rhPDGF is lyophilized (room temp storage) and delivered with a sterile, biocompatible, resorbable collagen sponge to contain and sustain the delivery and provide a matrix for new cell and tissue in growth. Collagen also absorbs wound fluid proteases.