Jim Shrine

ProCyte Corp. laid off 35 percent of its staff, cutting back from 83to 54 full-time employees, in a restructuring move following afailed Phase III trial of its lead drug for diabetic plantar ulcers.The Kirkland, Wash. company's action was taken less than a weekafter the 511-patient trial showed that Iamin gel, a tripeptide coppercomplex, failed to show statistical significance against placebotreatment.Karen Hedine, ProCyte's vice president of business operations, toldBioWorld that two drug groups and the placebo each achieved aone-third full-closure rate, which was one of two primaryendpoints. The drug groups and placebo also were equivalent in thesecond endpoint, achieving 80 to 90 percent median wound closure.ProCyte's results are the third this year in which a company with awound-healing product got better-than-expected results fromplacebo, resulting in a failed trial. On Oct. 6, TeliosPharmaceuticals Inc., of San Diego, reported that its Argidene Gelfor diabetic foot ulcers and placebo each achieved complete healingat 20 weeks in about 41 percent of patients. And on April 4,Magainin Pharmaceuticals Inc. released results of a Phase IIb/IIItrial of MSI-78 for impetigo showing response rates for threeconcentrations of the drug and placebo all achieved a clinical curerate of about 75 percent.Magainin, of Plymouth Meeting, Pa., took its topical anti-infectiveback into the clinic in August with the launch of a Phase III trial fordiabetic foot ulcers. Others with late-stage trials in that indicationinclude Chiron Corp., of Emeryville, Calif., which expects torelease Phase III results of it recombinant human platelet-derivedgrowth factor by the end of March; and Advanced Tissue SciencesInc., of La Jolla, Calif., recently initiated pivotal trials of itsDermagraft product, which is classified as a device.Hedine said the cutbacks at ProCyte involved every department. Itwill take the company "several months to finalize the analysis" ofthe Iamin trials before determining what action to take concerningthat drug in wound-healing indications, she said.But ProCyte's Japanese partner for Iamin, Kissei PharmaceuticalsCo. Ltd., of Matsumoto, is planning to go into the clinic next yearin Japan for wound-healing indications.ProCyte still plans to move an Iamin-related compound, Iamin-IB,forward for the treatment of inflammatory bowel disease. Thecompany reported in August that 60 percent of evaluable patients ina small study had symptomatic improvement, and using endoscopicevaluation, 80 percent showed significant reduction in inflammationof the bowel.Hedine said the company hopes to have a multi-center, placebo-controlled pilot Phase II trial of Iamin-IB under wayby then end of the year.Another drug in the ProCyte pipeline is Tricomin, a peptide coppercompound, that is expected to go into two small safety studies inhumans for male pattern baldness and patchy hair loss. Hedine saidPhase I trials are expected to start in the first quarter of 1995. KakenPharmaceuticals Co. Ltd., of Tokyo, is co-developing Tricomin.Chuck Noland, an analyst with Dakin Securities Corp. in SanFrancisco, told BioWorld he "isn't ready to bury the coppertechnology. It's very well documented that copper deficiencies aredirectly correlated with enzymatic processes that are necessary tonormal and healthy wound healing and tissue repair."He said upcoming trials in inflammatory bowel disease will go along way toward gauging the possibilities of copper technology,and that a best-case scenario for the wound-healing indicationwould have the company doing one more Phase III trial for diabeticfoot ulcers.Noland said ProCyte's management "has reacted properly at thisstage" to the negative news. And, he said, the fact that ProCytehasn't spent more than $30 million since its founding in 1986 ismore evidence of strong management.ProCyte's stock (NASDAQ:PRCY) fell 68 percent, from $8.87 to$2.81, on Oct. 17, the day the Iamin trial results were released.ProCyte gained 13 cents per share Monday to close at $2.88. n

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