NOXXON Pharma AG, the biopharmaceutical company focusing on the development of novel drugs based on its unique proprietary Spiegelmer® technology, announced today the successful completion of the first-in-human clinical trial with Spiegelmer® NOX-A12.
This Phase I study was designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy individuals following intravenous administration of the stromal cell-derived factor-1 (SDF-1) antagonizing Spiegelmer® NOX-A12. 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 would be dosed and be receiving a leukapheresis procedure if certain thresholds of circulating CD34 positive cells were reached, to further characterize the mobilized cells. This study goal was achieved, too. Further information about the clinical trial is available on www.clinicaltrials.gov (ID: NCT00976378).
Dr. Frank Morich, Chief Executive Officer of NOXXON, commented: "Based on exceptionally positive pre-clinical and clinical data, we strongly believe that NOX-A12 has the potential to be developed for acute as well as chronic indications in the area of hematological malignancies and/or solid tumors. NOX-A12 is scheduled to enter a multiple dose Phase I clinical trial by mid of 2010, and phase II clinical testing soon thereafter."
Source NOXXON Pharma AG