The first clinical trial of Amgen Inc.'s platelet-derived growthfactor (PDGF) shows the recombinant protein can help healbedsores.
Results of the Phase I/II trial in patients given different dosessuggest that PDGF will prove to be "a potent wound-healingagent in soft tissue," concluded the researchers reportingSaturday in The Lancet.
The scientists from the University of Texas Medical Branch inGalveston noted that bedsores or pressure sores are chronic,non-healing wounds that can sometimes lead to death. Tests ofPDGF in wounds that had reached into the tissue under the skinshowed that the protein is safe, and that the highest dose givento five of 20 patients enrolled in the 29-day trial significantlyreduced the size of the treated ulcers, as compared withcontrols.
PDGF induces repair processes in animals, triggering an influxof inflammatory and repair cells into wounds and acceleratingthe deposition of new scaffolding for tissue regeneration.
Although the number of patients was small, the encouragingresults "probably do reflect the biological effects of PDGF on thewound bed," the scientists wrote.
Kim Dorsey, spokeswoman for the Thousand Oaks, Calif.,company (NASDAQ:AMGN), told BioWorld that the drug is stillin Phase II testing, with no estimate yet available on whenPhase III trials would start.
The product will compete in a crowded market for wound-healing therapies. Chiron Corp. has been in Phase II trials forPDGF in skin ulcers. Novo Nordisk and Creative BioMoleculesalso are developing PDGF. Fibroblast growth factors fromSynergen Inc. (NASDAQ:SYGN) and California Biotechnology Inc.(NASDAQ:CBIO), along with Telios Pharmaceuticals Inc.'s Telio-Derm extracellular matrix of linked peptides, are otherpotential competitors.
Amgen's stock closed at $73.75 Monday, down $1. -- RobertaFriedman, Ph.D.
(c) 1997 American Health Consultants. All rights reserved.