DynaGen Inc. announced Tuesday that it has submitted anamendment to its investigational new drug (IND) applicationwith the FDA for authorization to begin Phase II clinical trialson its single-protein tuberculin test SPT I.
The test, which uses an antigen reagent that DynaGen(NASDAQ:DYGN) licensed from Case Western Reserve Universityin Cleveland, is intended for in vivo use as an aid to theconventional skin test procedure for diagnosing tuberculosis(TB).
DynaGen of Cambridge, Mass., recently completed its Phase Istudy of the SPT I test, in which the antigen was administeredintradermally to healthy volunteers. When administeredintradermally to a person infected with Mycobacteriumtuberculosis, the microorganism that causes TB, the testproduces a delayed hypersensitivity skin reaction.
The volunteers exhibited no clinically significant adverse sideeffects and the antigen appears to be safe. -- Jennifer VanBrunt
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