Greenwich Pharmaceuticals Inc. suffered a crushing blow Mondaywith the announcement that its carbohydrate drug for treatingrheumatoid arthritis was no more effective than placebo in a Phase IItrial.The announcement from the Fort Washington, Pa., company about thecompound, GW-80126, comes three months after Greenwichannounced that it would no longer seek U.S. marketing approval forTherafectin, its lead product that was developed for the sameindication. It has another compound, GW-92527.HCL, in Phase I trials,also for rheumatoid arthritis.Jeff Randall, chief financial officer for Greenwich, told BioWorld anadditional Phase I study for GW-92527.HCL likely will not belaunched until a partner with funding was found."We are open to a wide variety of potential structures," Randall said."We'll be happy to talk with anyone, and are anxious to entertainproposals as they come."We're obviously attempting to shepherd our limited cash resources,"Randall said. "Based on that we are not going to do any additionaldevelopment at this time."The company has a substantial backlog of preclinical compounds thathave been through screening for a variety of indications, and a suite ofpatents that provide proprietary protection for those compounds,"Randall said.Greenwich (NASDAQ:GRPA) has 35 million shares of stockoutstanding. The stock, trading at more than $15 in April of 1992, haslost ground since the FDA informed Greenwich in May 1992 that moredata was needed on the Phase III trial for Therafectin. It lost 19 centsMonday to close at $1.06 per share. Randall said the company had$11.8 million cash at the end of December and was burning about $4million per quarter.Product license applications (PLA) for Therafectin are pending inIreland and Switzerland. Agencies in the U.K., France and theNetherlands, citing PLA deficiencies, have notified Greenwich thatmore data is needed.The Phase II trial of GW-80126, a second-generation syntheticmonosaccharide, involved 325 patients in a double-blind, placebo-controlled study of two dosages. Four end points were established inthe six-month trial: painful joints, swollen joints, physicians'assessments of the patients' conditions, and the patients' ownassessments.Therapeutic success, achieved when all four efficacy variables returned(or were better) to the values observed at study entry, was realized for52 percent of the patients taking GW-80126 and 50 percent of thosetaking placebo."It cost this company several million dollars to prove, statisticallyanyway, that there was no benefit," Randall said. n
-- Jim Shrine
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