NOXXON Initiates Phase IIa of anti-CXCL12/SDF-1 Spiegelmer NOX-A12 for Treatment of Chronic Lymphocytic Leukemia

13-07-2012: NOXXON Pharma announced the treatment of the first cohort of three chronic lymphocytic leukemia (CLL) patients in a Phase IIa clinical trial of its NOX-A12 anti-CXCL12/SDF-1 (CXC Chemokine Ligand 12 / Stromal Cell-Derived Factor-1) Spiegelmer®. CXCL12 signaling has been shown to play an important role in the pathophysiology of CLL, especially in the interaction of leukemic cells with the tissue microenvironment. The therapeutic concept of NOX-A12 is to inhibit such tumor-supporting interactions and thereby sensitize CLL cells to chemotherapy.

NOXXON's multi-center, open-label, uncontrolled study will be conducted on 33 relapsed CLL patients, all of whom were previously treated for CLL. The patients will receive NOX-A12 in combination with a background therapy of bendamustine and rituximab (BR). Combination treatment with NOX-A12 and BR will occur in 6 cycles of 28 days, with a follow-up period of 30 months. Each patient will receive up to three different doses of NOX-A12 as part of an individualized dose titration. The primary efficacy endpoint of the study will be complete remission (CR) rate.