The initial clinical trial was a Phase I study of escalating single doses of the drug, G4544, in 30 normal volunteers. The endpoints of the study were to determine safety and to assess pharmacokinetics and oral bioavailability. The drug was tested over a dosing range of the active ingredient from 30 to 150mg, and no adverse effects attributable to G4544 were observed in this study.
Initial analysis of plasma samples of low doses showed that the active ingredient was absorbed after oral administration. Low doses of the active ingredient in Ganite administered by intravenous or subcutaneous injections have shown clinical activity in a range of skeletal diseases, including hypercalcemia, bone metastasis (myeloma and breast cancer), Paget’s disease, and osteoporosis.
G4544 is a new tablet formulation using delivery technology developed by Emisphere Technologies that enables oral absorption of the active ingredient contained in Ganite (gallium nitrate injection). Genta has exclusively licensed the intellectual property related to G4544.