ImmunoTherapeutics Inc. said Tuesday that it filed aninvestigational new drug application for its immunomodulator,ImmTher, in patients with infectious disease.Initially the Fargo, N.D., company will test ImmTher in a Phase IItrial in hepatitis C patients. The compound may be tested lateragainst parasitic diseases and, possibly, HIV/AIDS, depending uponcompletion of a "reasonable protocol for study. If we see benefit inhepatitis C, no question we'll move it along," Gerald Vosika, thecompany's president and chief scientific officer, told BioWorld.ImmTher, a disaccharide peptide, already is in Phase II trials formetastatic colorectal cancer and metastatic prostate cancer. Plansare under way to test the compound in malignant melanoma, Vosikasaid.ImmTher is being tested against infectious diseases because of itsimmunostimulant effects and because of preclinical data in viraldisease that demonstrated the benefit of that type of compound,Vosika said. ImmTher is a macrophage activator based oncomponents of BCG, an attenuated strain of the tubercularbacterium.The company's second immunomodulator, Theramide, is in Phase Itrials for malignant disease. It metabolizes slower than ImmTherand can be given without a liposome carrier, Vosika said.Theramide forms small liposome-like structures known as mini-micelles, which have the same tissue distribution as the liposome-incorporated formulation. _ Jim Shrine
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