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Differences become evident best in the repeat and the long-term administration. The best studies at ImuThes to date employed repeat injection every three days for three weeks. There was no sign of weight loss or other signs of toxicity over this period, but there was a sustained reduction of the protein levels to be reduced (reduction of HBV S- and E-antigens levels and viral load in a transgenic model of HBV). The specific uptake of siFECTplus formulations into liver is ≥ 85%.
Multiple injections of Stanford HBV mice with siFECTplus particles (1mg/kg, tail vein injection at day 1/4/7/10/13/16/19) leads to a reduction in viral load comparable to lamivudin at 200mg/kg, i.p., daily (Fig. 5). The reduction is accompanied by a corresponding knock-down in S and E antigens. Changes in ALT and LDH levels are minimal. Markers of liver function (ALT and LDH) and Electrolytes are normal. There is no, or only small, interferon response (Fig. 6). Renal function (urea and creatinine) is unaffected. Blood smears show no anomalies.
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