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NOXXON Announces Initiation of First-in-Human Clinical Trial with Hematopoietic Stem Cell Mobilizing Spiegelmer® NOX-A12
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 (ID: NCT00976378).
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.
NOX-A12 mobilizes hematopoietic stem cells from the bone marrow by disrupting the SDF-1 gradient that normally attracts them to their niches. Studies in animal models demonstrate that treatment with a single dose of Spiegelmer® NOX-A12 significantly mobilizes hematopoietic progenitor cells in a dose dependent manner. NOXXON receives grant support from the German Federal Ministry of Education and Research (BMBF) for the preclinical program and the first-in-human clinical trial with NOX-A12.
About Hematopoietic Stem Cell Transplantation
Hematopoietic stem cell transplantation is considered the treatment of choice for many patients with severe malignant or non-malignant, acquired or congenital disorders of the hematopoietic system or for patients with chemosensitive, radiosensitive or immunosensitive tumors. Better management of the patients, improved supportive care, increased donor pools and novel conditioning regimes have extended its use to new patient categories and new disease conditions.
Spiegelmers® (L-aptamers) are chemical entities based on synthetic mirror-image 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 toll-like receptors and they showed an exceptionally favorable immunogenicity profile in pre-clinical testing.
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