NOXXON commences Spiegelmer NOX-A12 Phase IIa trial in CLL

NOXXON Pharma today 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. NOXXON expects interim results to be available at the upcoming American Society of Hematology Annual Meeting in Atlanta, Georgia which will be held from 8-11 December, 2012.

Although BR is one of the established therapies for CLL, there remains significant need for improved therapy in relapsed patients. Recent publications indicate that the complete remission rate for BR therapy of relapsed CLL is approximately 15%.

NOX-A12 is the only anti-cancer agent in active clinical development that neutralizes the CXCL12 ligand, thereby resulting in a complete block of CXCL12 signaling through its two receptors, CXCR4 and CXCR7. Competing agents act at the receptor level and only inhibit one of the two CXCL12 receptors.