Hygeia Pharmaceuticals Inc., a subsidiary of Hygeia Holdings(VSE:HYG), announced Tuesday that it has received approvalfrom the FDA to begin Phase I trials on its human monoclonalantibody, Monopharm-C, for treating colorectal cancer,pancreatic carcinoma and adenocarcinoma of the lung.
Hygeia of San Diego filed its investigational new drug (IND)application on Monopharm-C with the FDA in April; in late Julythe company supplied the agency with the additionalinformation regarding the IND that FDA had requested in June.
Monopharm-C is a human monoclonal antibody produced by invitro immunization; that is directed specifically against aunique antigen found on adenocarcinoma cells. The upcomingPhase I trial will be the first test of a fully human monoclonalIgM antibody as a therapeutic, according to the company.
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