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NOXXON Announces the Completion of the First-in-Human Clinical Trial with Spiegelmer® NOX-A12Berlin, Germany, )
This Phase I study was designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy individuals following intravenous administration of the stromal cellderived 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 preclinical 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."
NOX-A12 specifically antagonizes stromal cellderived factor-1 (SDF-1), a chemokine which attracts and activates immune- and nonimmune cells. SDF-1 binds with high affinity to the chemokine receptors CXCR4 and CXCR7. The CXCR4/SDF-1 axis has been shown to play a role in stem cell mobilization, vasculogenesis, tumor growth and metastasis. Inhibition of the SDF-1 binding to CXCR4 sensitizes tumor cells to chemotherapy suggesting that NOX-A12 in combination with chemotherapy could be beneficial in the treatment of various cancers.
NOX-A12 has been evaluated in models of stem cell mobilization, angiogenesis, inflammation and lung and kidney injury. In these models NOX-A12 reduced pathological angiogenesis and tissue remodeling. In preclinical safety and two weeks toxicology studies NOX-A12 was safe and did not show any organ toxicity. In particular NOX-A12 did not exert any immunotoxicity effects, such as Tolllike receptor activation or changes in cytokine levels.
NOXXON receives grant support (Grant no. 0315118) within the program "KMUinnovativ" from the German Federal Ministry of Education and Research (BMBF) for the preclinical program and the firstinhuman clinical trial with NOX-A12.
Spiegelmers® (Laptamers) are chemical entities based on synthetic mirrorimage oligonucleotides which are highly selective for their pharmacological target and potent inhibitors of target function. They combine the benefits of small molecule drugs and biopharmaceuticals. Due to their unique mirror image configuration Spiegelmers® are not metabolized and do not hybridize with native nucleic acids. Unlike conventional nucleic acids, Spiegelmers® do not activate the innate immune response via tolllike receptors and they showed an exceptionally favorable immunogenicity profile in preclinical testing.
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