DynaGen Inc. on Wednesday announced that it has initiated aPhase I clinical trial for SPT I, a single-protein tuberculin test.
SPT I is intended for in vivo use for screening for tuberculosisinfection by the standard skin test procedure, said DynaGen(NASDAQ:DYGN) of Cambridge, Mass.
Patient recruitment is now under way for the trial, in whichSPT I will be administered intradermally to healthy volunteers.The test produces a delayed hypersensitivity skin reactionwhen administered intradermally to a person infected with M.tuberculosis, the organism that causes TB, the company said.The study will be conducted at LeeCoast Research Center Inc. inFort Myers, Fla.
The current TB skin test, the Mantoux test, which uses apurified protein derivative (PPD), has significant batchvariability, DynaGen said, and the World Health Organizationhas said that a "much better kind of tuberculin than PPD" isneeded.
DynaGen said potential advantages of SPT I include more easilyinterpreted test results and greater manufacturingreproducibility and standardization.
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