Genta Completes Initial Clinical Dosing of G4544, a New Oral Drug for Bon...( Safety Analysis Shows Good Toleran...),Health

Safety Analysis Shows Good Tolerance with No Serious Adverse Reactions

BERKELEY HEIGHTS, N.J., Nov. 15 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA) released findings from the initial clinical dosing of G4544, the Company's proprietary small molecule that is intended as a treatment for diseases associated with accelerated bone loss. The Phase 1 study, which was conducted in normal volunteers, has shown good tolerance with oral bioavailability of the active ingredient, and an excellent safety profile without serious adverse reactions. The findings were released in an abstract published in the proceedings of the upcoming annual meeting of the American Society of Hematology.

G4544 is a new tablet formulation using delivery technology developed by Emisphere Technologies, Inc. that enables oral absorption of the active ingredient contained in Ganite(R) (gallium nitrate injection). Ganite(R) is marketed by Genta and approved in the U.S. for treatment of cancer-related hypercalcemia that is resistant to hydration. 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.

The initial clinical trial was a Phase 1 study of escalating single doses of 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 150 mg, and no adverse effects attributable to G4544 were observed in this study. Initial analysis of plasma samples of low doses sh
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