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

    July 11, 2012

Berlin, Germany- 11 July 2012- 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%1.
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.

About NOXXON Pharma AG
NOXXON Pharma is a biopharmaceutical company pioneering the development of a new class of proprietary therapeutics called Spiegelmers. Spiegelmers are the chemically synthesized, non-immunogenic alternative to antibodies. NOXXON has a diversified portfolio of clinical stage Spiegelmer® therapeutics:
NOX-E36 is an anti-CCL2/MCP-1 (C-C Chemokine Ligand 2 / Monocyte Chemoattractant Protein-1) Spiegelmer® currently in a Phase IIa study in diabetics with albuminuria. CCL2 is a pro-inflammatory chemokine involved in recruitment of immune cells to inflamed tissues.

NOX-A12 is an anti-CXCL12/SDF-1 (CXC Chemokine Ligand 12 / Stromal Cell-Derived Factor-1) Spiegelmer® that has completed Phase I. Phase IIa studies in two hematological cancers, multiple myeloma (MM) and chronic lymphocytic leukemia (CLL), have begun recruiting patients. CXCL12 is a chemokine mediator of tumor invasion, metastasis and resistance to chemotherapy.

NOX-H94 is an anti-hepcidin Spiegelmer® that has completed a comprehensive single and multiple ascending dose Phase I study and a Phase I endotoxin challenge study, designed to test the ability of NOX-H94 to block hepcidin-mediated hypoferremia in healthy volunteers. A Phase IIa study of NOX-H94 in myeloma and lymphoma patients with anemia is planned to start mid-2012. Hepcidin is the key regulator of iron metabolism and a mediator of iron restriction in anemia of chronic disease.

The Spiegelmer® platform provides the company with powerful and unique discovery capabilities, which have generated a number of additional leads under preclinical investigation. Located in Berlin, Germany, NOXXON is a well-financed mature biotech company with a strong syndicate of international investors, approx. 60 employees and a highly experienced management team.
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