Cytel Corp.'s Theradigm-HBV, the company's therapeuticvaccine for the treatment of chronic hepatitis B infection (HBV),is able to produce an HBV-specific cytotoxic T lymphocyte(CTL) response in healthy volunteers, the company reportedthis week at the Keystone Conference on Tumor Viruses inTaos, N.M.
The study looked at 25 subjects treated with either placebo or5 mcg, 50 mcg or 500 mcg of Theradigm-HBV. All five patientstreated with 500 mcg of the compound exhibited a CTLresponse, company spokeswoman Karin Eastham told BioWorld.Two of the six patients treated with 50 mcg showed a response,while none of the five patients given 5 mcg of Theradigm-HBVproduced CTLs.
Eastham said only produced mild adverse reactions wereencountered during the trial -- principally temporaryheadaches and dose-site skin reactions.
The San Diego company plans to begin a Phase II trial of theagent in April. In that trial, 20 patients with chronic activehepatitis B and 20 chronic carriers of the infection will betreated with Theradigm-HBV and compared with a placebogroup. The researchers will examine viral clearance andantigen levels in plasma. -- Karl Thiel
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