NOXXON commences NOX-A12 Phase IIa trial in relapsed MM

NOXXON PharmaSep 26 2012

NOXXON Pharma today announced the treatment of the first cohort of three multiple myeloma (MM) patients in a Phase IIa clinical trial of its anti-CXCL12/SDF-1 (CXC chemokine ligand 12 / Stromal Cell-Derived Factor-1) Spiegelmer^® NOX-A12. CXCL12 signaling has been shown to play an important role in the pathophysiology of MM, especially in the interaction of MM cells with the bone marrow microenvironment. By inhibiting this interaction NOX-A12 sensitizes the cancer cells to chemotherapy.

This is the third Phase IIa trial that NOXXON has started this year following the NOX-E36 Phase IIa for the treatment of diabetic nephropathy in June and the NOX-A12 Phase IIa for the treatment of Chronic Lymphocytic Leukemia in July.

MM is a hematologic or blood cancer that develops in the bone marrow in which normal antibody-producing cells transform into malignant myeloma. The growth of the cancer cells in the bone marrow blocks production of normal blood cells and antibodies, and also causes lesions that weaken the bone. According to the US National Cancer Institute (NCI), MM is the second most common blood cancer in the United States and accounts for approximately one percent of all cancers.

NOXXON's multi-center, open-label, uncontrolled study will be conducted in Europe on 28 relapsed MM patients who were all previously treated for their cancer. The patients will receive NOX-A12 in combination with a background therapy of Velcade^®/bortezomib and dexamethasone (VD). Combination treatment with NOX-A12 and VD will occur in 8 cycles of 21 days, with a follow-up period of one year. 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 the overall response rate, which includes patients with complete and partial responses to therapy. NOXXON expects interim results to be available by the end of 2012.

Although VD is one of the established therapies for MM, there remains significant need for improved therapy in relapsed patients. Recent publications indicate that the complete response rate for VD therapy of relapsed/refractory MM is approximately 17%.

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

Based on information from the NCI, the American Cancer Society and the GLOBOCAN database, NOXXON estimates that there are approximately 100,000 MM patients requiring treatment every year in the combined markets of the EU-5 (France, Germany, Italy, Spain and the United Kingdom), Japan and the United States.