Several years after ProCyte Corp.'s copper peptide gel for diabetic plantar ulcers failed in a Phase III trial, the company has won marketing clearance for the compound — which already is sold for general wound care — in a hydropolymer wound dressing.
Redmond, Wash.-based ProCyte will begin selling the OsmoCyte PCA Pillow Wound Dressing immediately, through its distributor, Bard Medical, of Covington, Ga.
"It's the one product that merges our two core technologies: the copper peptide and the hydropolymer," said Jon Sortland, ProCyte's manager of finance and accounting.
Used in Iamin gel, the copper peptide failed to achieve its primary endpoints in a Phase III trial, which sent ProCyte's stock plunging 68 percent and led to the cutback of a third of the company's staff. (See BioWorld Today, Oct. 18, 1994, p. 1, and Oct. 25, 1994, p. 1.)
"The company believes that copper peptide does aid in wound healing, including diabetic ulcer wounds," Sortland said. "It has an active ingredient that accentuates wound healing, and we have data to prove that."
He cited study design in 1994 as a possible reason why the difference between treated subjects and those treated with placebo failed to reach statistical significance in reducing wound size and achieving wound closure.
"We have various product candidates in various stages of development, mostly for specialty wound healing," Sortland added. Among those is a product for patients who have undergone hair-transplant surgery.
ProCyte's stock (NASDAQ:PRCY) closed Tuesday at $1.562, up $0.312. — Randall Osborne