Aptamers from L-oligonucleotides proven safe and non-toxic
Berlin - On Monday, German NOXXON Pharma AG announced the successful completion of a Phase I trial with the 1st "Spiegelmer" NOX-A12, an antagonist of stromal cell-derived factor-1 (SDF-1). Final data analysis demonstrated an excellent safety and tolerability up to the highest tested dose of 10.8 mg/kg. In addition, analysis by flow cytometry revealed a long-lasting and dose dependent mobilization of WBC and CD34 positive cells. The protocol also allowed that an additional group of volunteers received leukapheresis, should certain thresholds of circulating CD34 positive cells were reached, to further characterize the mobilized cells and this was undertaken. Noxxon intends to develop its intravenously administered drug candidate in haematological malignancies and/or solid tumours. NOX-A12 is scheduled to enter a multiple dose Phase I clinical trial by mid 2010, and phase II clinical testing soon thereafter. NOX-A12 has been evaluated in models of stem cell mobilization, angiogenesis, inflammation and lung and kidney injury. In all of these models, NOX-A12 reduced pathological angiogenesis and tissue remodelling. In preclinical safety and two weeks toxicology studies, NOX-A12 was established as safe with no organ toxicity. In particular, NOX-A12 did not exert any immunotoxicity effects, such as Toll-like receptor activation or changes in cytokine levels.