Cytel Corp. has achieved two developmental milestones, thecompany's president and chief executive, Jay Kranzler, announcedWednesday at the Hambrecht & Quist Annual Life SciencesConference.
Kranzler said Cytel (NASDAQ: CYTL) of San Diego completed Phase Iclinicals on Theradigm-HBV, its hepatitis B vaccine, and has filed aninvestigational new drug (IND) application for Cylexin, its cell-adhesion product.
The company is now evaluating data from its safety and tolerabilitystudy of Theradigm-HBV in healthy volunteers to assess whether theagent can produce specific cytotoxic T cell (CTL) response against thehepatitis B virus. Cytel said it hopes to complete its analysis in thefirst quarter of this year.
In the second quarter Cytel hopes to move to Phase II trials ofTheradigm-HBV to assess the drug's ability to induce CTLs in patientswith chronic hepatitis.
Following FDA approval of its IND, the company plans to beginhuman clinical trials of Cylexin, its carbohydrate-based small-molecule selectin blocker. Cylexin is being developed for thetreatment of diseases involving reperfusion injury -- tissue damagethat occurs when blood flow is restored to tissue that has beenischemic, as in heart attacks, stroke and trauma.
The company said it hopes to move by midyear from a Phase I safetyanalysis of Cylexin in healthy volunteers to a Phase II assessment ofthe efficacy of the agent in treating acute lung injury secondary toreperfusion following a pulmonary thromboembolectomy.Subsequent trials will evaluate the ability of Cylexin to preventreperfusion to the heart following myocardial infarction.
-- Karl A. Thiel Associate Editor
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