Cytel Corp. said Friday it has started Phase II trials ofTheradigm-HBV, its therapeutic vaccine for the treatmentof chronic hepatitis B infection.It is the lead drug candidate in the San Diego company'simmune stimulation program, and designed to activatecytotoxic T lymphocytes that specifically recognize HBV-infected liver cells and stop virus replication.The two arms of the trial _ each designed to enroll 25patients _ will be conducted at 10 centers in the U.S. andCanada. One arm of the study involves patients withchronic active hepatitis, and the other involves chroniccarriers of the disease."In the Phase I study it was able to induce hepatitis B virus-specific cytotoxic T cells (in healthy volunteers)," BobChesnut, vice president of research and development forCytel's immune stimulation program, told BioWorld. "Thedrug's design is such that it's peptide-based, so we haveselected a peptide derived from hepatitis B virus that isknown to be recognized by the immune response. Thestrategy is to stimulate the immune system sufficiently bydelivering that peptide immunogenic form such that it willbe able to specifically activate the immune response andlead to clearance of the hepatitis B infection."Cytel also is conducting preclinical studies of the drug'sability to induce specific cytotoxic T lymphocyte responsesagainst other infectious disease such as HIV and hepatitisC, and cancers such as malignant melanoma and cervicalcarcinoma. _ Jim Shrine
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