Becaplermin

Overview

Platelet-derived growth factor (PDGF) is normally released by platelets and macrophages at a wound site, where it is a key driver of granulation-tissue formation. Becaplermin is the BB homodimer of PDGF produced in yeast by recombinant DNA technology, delivered in a preserved sodium-carboxymethylcellulose gel.

The pivotal phase 3 trial in 382 patients showed that becaplermin gel 100 µg/g, combined with sharp debridement and good wound care, significantly increased the incidence of complete wound closure (50% vs 35% with placebo) and reduced the time to closure. It was approved by the FDA in 1997 and marketed as Regranex.

Becaplermin carries an FDA boxed warning: an increased risk of cancer mortality was observed in patients who used three or more tubes of the product. It is applied as a thin layer once daily and covered with a moist saline dressing; the amount is calculated from ulcer dimensions.

Mechanism of Action

PDGF-BB engages PDGF receptor-β tyrosine kinases, activating downstream PI3K/Akt and MAPK signalling that drives migration, proliferation and extracellular-matrix production by fibroblasts and smooth-muscle-like cells. This recapitulates the natural PDGF signal released during haemostasis, accelerating the proliferative phase of healing in chronic wounds where endogenous growth-factor signalling is deficient.