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NOXXON Pharma AG's SDF-1 inhibitor NOX-A12 Completes Phase I  
12/12/2011 11:06:28 AM

Berlin, Germany- 12 December 2011- NOXXON Pharma, a biopharmaceutical company pioneering the development of a new class of proprietary therapeutics called Spiegelmers, today announced the completion of Phase I single and multiple dose clinical trials of its SDF-1 inhibitor NOX-A12. In Phase I studies with healthy volunteers single doses of NOX-A12 up to 10.8 mg/kg and daily doses up to 2 mg/kg for five days were found to be safe and well tolerated and resulted in dose-dependent mobilization of white blood cells and CD34+ cells as predicted by preclinical studies.

NOX-A12 pre-clinical results in hematological malignancies will be presented in a talk at the annual meeting of the American Society of Hematology (ASH) in San Diego, USA from 10-13 December 2011. Members of NOXXON’s drug development team and collaboration partners will be at the ASH conference to explain the mode of action and clinical potential of this innovative drug candidate.

The titles and contributors to the three NOX-A12 presentations at ASH are as follows:

- Oral presentation Monday, December 12, 7:15 PM; Session 652; Room 6A

L-Stereoisomer RNA Oligonucleotide Anti-SDF-1 (NOX-A12) Disrupts the Interaction of Multiple Myeloma Cells with the Bone Marrow Milieu In Vivo, Leading to Enhanced Sensitivity to Bortezomib

A. M. Roccaro, A. Sacco, P. Qaung, A. Azab, P. Maiso, F. Azab, Y. Zhang, G. C. Issa, Y. Liu, H. T. Ngo, A. Kruschinski, I. M. Ghobrial

- Poster presentation Sunday, December 11, 6:00 PM-8:00 PM; Session 711; Poster II in Hall GH Rapid and Efficient Mobilization of Murine Hematopoietic Stem and Progenitor Cells with NOX-A12, a New Spiegelmers-Based CXCR4/SDF-1(CXCL12) Antagonist M. Scheller, F. Schwoebel, D. Vossmeyer, A. Leutz

- Poster presentation Monday, December 12, 6:00 PM-8:00 PM; Session 641; Poster III in Hall GH The Spiegelmer NOX-A12, a novel SDF-1 (CXCL12) inhibitor, and its effects on Chronic Lymphocytic Leukemia (CLL) cell migration.

J. Hoellenriegel, D. Zboralski, Z. Estrov, W. G. Wierda, M. Keating, A. Kruschinski, J. A. Burger

Based on compelling pre-clinical data in hematological and solid tumors, NOXXON believes that NOX-A12 has the potential to be developed for treatment of multiple oncology indications. Initiation of the first Phase IIa trial of NOX-A12 in a hematological tumor indication is planned early in 2012, subject to regulatory and ethics committee approvals.

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 targets the pro-inflammatory chemokine MCP-1 (CCL2) and is currently in Phase Ib for complications of type 2 diabetes including nephropathy. A Phase IIa study in diabetics with renal impairment is currently in preparation.

- NOX-A12 targets SDF-1 (CXCL12), a chemokine mediator of metastasis and resistance to chemotherapy in cancer, and has completed Phase I. Clinical Trial Applications have been submitted for Phase IIa studies in hematological oncology indications.

- NOX-H94 targets hepcidin, the key regulator of iron metabolism and mediator of iron restriction in anemia of chronic disease, and is currently in a comprehensive single and multiple ascending dose Phase I study.

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.

For more information, please visit: www.noxxon.com

NOXXON Pharma AG

Emmanuelle Delabre

T: +49-(0)30-726247-100

edelabre@noxxon.com

College Hill Life Sciences

Dr. Robert Mayer

T: +49-(0)89-57001806

robert.mayer@collegehill.com

About NOX-A12

NOX-A12 specifically antagonizes stromal cell-derived factor-1 (SDF-1), a chemokine which attracts and activates immune- and non-immune cells. SDF-1 binds with high affinity to the chemokine receptors CXCR4 and CXCR7. The SDF-1 / CXCR4 / CXCR7 axis has been shown to play a role in stem cell mobilization, vasculogenesis, tumor growth and metastasis. Inhibition of the SDF-1 binding to its receptors sensitizes tumor cells to chemotherapy and in some solid tumors prevents invasion and metastasis, suggesting that NOX-A12 in combination with chemotherapy could be beneficial in the treatment of various cancers.

NOX-A12 has shown promising activity in models of stem cell mobilization and both hematological and solid tumors. In Phase I studies with healthy volunteers, single doses of NOXXON’s SDF-1 inhibitor, NOX-A12, up to 10.8 mg/kg and daily doses up to 2 mg/kg for five days were found to be safe and well tolerated and resulted in dose-dependent mobilization of white blood cells and CD34+ cells as predicted by preclinical studies.

NOXXON received grant support within the program ”KMU-innovativ” from the German Federal Ministry of Education and Research (BMBF) for the preclinical program and the Phase I clinical trials with NOX-A12.

Further information about the planned clinical trial in relapsed CLL patients is available at ClinicalTrials.gov (ID: NCT01486797).


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