NOXXON Initiates First-in-Human Clinical Trial with Hematopoietic Stem Cell Mobilizing Spiegelmer® NOX-A12
News Nov 03, 2009
NOXXON Pharma AG announced the successful initial dosing of healthy volunteers in a first-in-human clinical trial with Spiegelmer® NOX-A12. NOX-A12 is NOXXON’s second drug candidate entering the clinical stage of development within only five months.
The Phase I program is currently being conducted in Germany following review and approval of the Clinical Trial Application by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM).
This single center study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics in up to 42 individuals, following intravenous administration of the hematopoietic stem cell (HSC) mobilizing Spiegelmer® NOX-A12. Further information about this clinical trial is available on www.clinicaltrials.gov.
Dr. Frank Morich, Chief Executive Officer of NOXXON, commented: “Based on exceptionally positive pre-clinical data, we strongly believe that, NOX-A12 has the potential to become an improved alternative for hematopoietic stem cell mobilization. Our goal is to have NOX-A12 approved by 2014. In this ongoing trial we are expecting to see a good safety profile and to gain initial efficacy data that will further validate the value of the Spiegelmer® technology for the drug development in areas with high unmet medical need.”
NOX-A12 binds and neutralizes the chemokine Stromal Cell-Derived Factor-1 (SDF-1, also known as CXCL12), a key regulatory element in the homing and retention of HSCs in the bone marrow. Mobilized HSCs can be collected by leukapheresis, a process that is generally preferred to invasive bone marrow harvesting.
NOXXON’s pre-clinical data indicate that the efficacy and pharmacokinetic properties of NOX-A12 may lead to a simpler and more effective HSC mobilization procedure compared to current practice.
The results obtained in this Phase I clinical trial will form the basis for the Phase II program to be conducted by mid 2010 in patients with Multiple Myeloma or non-Hodgkin’s Lymphoma undergoing autologous stem cell transplantation.