Cytel Corp. said Monday it has started human clinical trials of itscarbohydrate-based small molecule drug that will bind both E- and P-selectin receptors. It is being developed for the treatment of diseasesinvolving reperfusion injury.The priority cell adhesion blocker, Cylexin (formerly called CY1503),is being tested in a Phase I, double-blind, placebo-controlled, dose-escalation study to assess safety, tolerability and pharmocokinetics inhealthy volunteers."This is the first selectin blocker going through the clinic intended togo all the way through the clinic," Jay Kranzler, president and CEO ofthe San Diego company, told BioWorld. "It's way ahead of anyoneelse. If the area of selectin blockage is an important one clinically andcommercially, we expect to realize that with Cylexin."He said the Phase I study should take about a month. A Phase II studytargeting reperfusion injuries following lung surgery is scheduled tostart in the third quarter of this year, Kranzler said, and a Phase II formyocardial infarction is expected to start in the fourth quarter.Reperfusion injury involves tissue damage that can occur when bloodflow is restored to tissue that has been ischemic, as in heart attacks,stroke and trauma."Cylexin has demonstrated efficacy in a whole range of models,including the two areas we're targeting in the clinic," Kranzler said.Cytel entered the clinic about a year and a half ago with a murinemonoclonal antibody designed to block neutrophil binding to E-selectin, but that product, called CY1787 and intended for sepsis, wasnever intended to be taken past Phase I. A humanized form of themolecule, called CY1788, is being developed. Cytel also is developinga compound (CY1747; humanized CY1748) that should enter the clinicnext year, Kranzler said. The indication has not been finalized, but itwill be for a form of reperfusion injury, he said.James Paulson, Cytel's vice president, cell adhesion, said, "Initiation ofclinical trials for Cylexin represents a major milestone for our selectinprogram and for our core carbohydrate synthesis technology" _produced by using enzymes to make the critical chemical links withinthe molecule, which Paulson said can be leveraged for otherpharmaceutical and non-pharmaceutical applications. n
-- By Jim Shrine
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