Telios Pharmaceuticals Inc.'s trial of Argidene Gel for diabetic footulcers was done in by unexpected healing in the control group.A nearly equal number of patients in the treatment and controlgroups (41 and 40 percent, respectively) achieved complete healingat 20 weeks, the primary endpoint in the blinded, randomized,controlled 150-patient trial."We just cannot explain the placebo healing rate," David DuncanJr., chief financial officer of Telios, told BioWorld. "We hadexpected, based on conversations with our clinicians, that we wouldheal between 20 to 25 percent of the controls. They're as mystifiedby this as we are."Telios, of San Diego, asked NASDAQ Thursday morning to put ahalt on trading of its stock (TLIO) to let the information getdisseminated through the marketplace, Duncan said.Nancy McRae, Telios' investor relations manager, told BioWorld,"All I am at liberty to tell you is we requested trading be halted forthe day. There may be additional news pending, but I am not atliberty to comment."Duncan said he, too, would not elaborate on what news is pending.But he said Telios stock would resume trading today.The company used a previous 65-patient trial in diabetic foot ulcerpatients, as well as other data, in submitting a premarket approval(PMA) application with the FDA in March 1993. Telios completeda public offering of 3 million shares of convertible stock and step-up warrants last month that raised $13.4 million, more than the $9million the company was hoping for.Hambrecht & Quist Inc. was the lead placement agent for theoffering. The offering's prospectus fully disclosed that trial resultswere coming in the fourth quarter, Duncan said.Argidene also is being evaluated in venous stasis ulcers and partialthickness burns in children. Burn trial results announced in Juneshowed statistical significance in accelerated wound healing andreduction in skin grafts. A 150-patient trial in venous stasis ulcershas been completed but not analyzed.Duncan said the company will decide where to go from here afterfurther analysis in the diabetic foot ulcer trial, which will includelooking at the secondary endpoints of rate and time of healing, andafter analysis of venous stasis ulcer data."It's too early to tell the ramifications [of this trial's result] on thePMA," Duncan said. "Right now we plan to continue the PMA."He said the analysis will take several weeks or months, but it won'tchange the results as far as the primary endpoint.The earlier diabetic foot ulcer trial, which went 10 weeks instead of20, showed complete healing in 35 percent of the patients. But only8 percent of the controls were healed.The FDA responded to Telios' original PMA for Argidene byasking, in January, for more information. The agency wantedfurther data showing that a representative cross-section of thepatient population with foot ulcers was enrolled in the 65-patienttrial. The FDA also asked the company to explain how the safety ofArgidene in patients with venous stasis or sickle-cell ulcers isrelevant to diabetic ulcers.Telios has another product, TP-9201, an anti-clotting agent, inPhase I trials. The company has about $22 million in cash and some25 million shares outstanding, McRae said. n
-- Jim Shrine
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