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news.Immunotech Laboratories has announced that the Phase I and Phase II field trials in Bulgaria of the company’s HIV/AIDS and Hepatitis C virus treatment (“ITV-1 Treatment”) have been successfully completed.
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The clinical test are being conducted through Immunotech Laboratories, BG ("IMMB-BG") a 49% owned subsidiary of Immunotech Laboratories.
Since 2013, IMMB-BG hired and funded the Clinical Research Organization ("CRO") to conduct all preclinical and monitoring Phase III clinical studies.
The product for the Bulgarian study was produced under GMP conditions by a U.S. Contract Manufacturing Facility.
The toxicity testing of ITV-1 on animals has also been successfully completed as well as a complete pharmacokinetics (PK) analysis of how the treatment is distributed through the blood system.
The Company is making its application for the permit to move to Phase III full scale clinical testing on patients. The initial testing will begin upon receipt of the Phase III permit which the Company expects to receive within 60 days of acceptance of the application.