Deutsche Effecten- und Wechsel-Beteiligungsges. AG

EANS-News: DEWB investment holding NOXXON initiates Phase I of NOX-H94 for Anemia of Chronic Disease

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Company Information

Subtitle: First-in-man for third Spiegelmer® product

Berlin, Germany, 6 September 2011 (euro adhoc) - NOXXON Pharma today announced
the initiation of a Phase I clinical trial for NOX-H94, the Company´s third
compound to enter the clinic. NOX-H94 is a Spiegelmer® designed to treat anemia
of chronic disease by targeting the peptide hormone hepcidin, the key regulator
of iron metabolism. Hepcidin is up-regulated by acute and chronic inflammatory
reactions resulting in "iron restriction", which means that iron is blocked
inside cellular stores and not available for hemoglobin synthesis. This is in
contrast to "iron deficiency", in which iron stores are depleted. 

Sujects will first be administered escalating single doses of NOX-H94 and will
then be tested with multiple doses. Both the intravenous and sub-cutaneous
routes of administration will be tested. The primary objective of the study is
to assess the safety and tolerability of NOX-H94 with a secondary objective to
test pharmacokinetic/pharmacodynamic responses to the compound.

Mr. Iain Buchanan, Chief Executive Officer of NOXXON, commented: "The recent
entry of NOX-H94 into human trials marks the third Spiegelmer® product in
clinical development and underlines the transition that NOXXON has made to a
company with clinical-stage assets. Preliminary data arising from this study
suggest that NOX-H94 is safe, well tolerated and acts in a manner as predicted
by preclinical studies. NOXXON will provide further updates on the progress of
NOX-H94 and other compounds in its pipeline later in the year." 

The underlying causes of anemia of chronic disease are mainly infections,
cancer, autoimmune diseases and chronic kidney disease. Estimated prevalence
reaches approximately 70% in certain cancers and autoimmune diseases and
constitutes an area of significant medical need. In this US, more than 1 million
people are estimated to have anemia of chronic disease.

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, nonimmunogenic 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 such as nephropathy.
• NOX-A12 targets SDF-1 (CXCL12), a chemokine mediator of metastasis and
resistance to chemotherapy in cancer, and is currently in Phase I.
• NOX-H94 targets hepcidin, the key regulator of iron metabolism and mediator of
iron restriction in anemia of chronic disease, and is currently in Phase I.

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:

About NOX-H94
NOX-H94 is a Spiegelmer compound targeted at the iron-regulating protein
hepcidin. Hepcidin is the master regulator of iron homeostasis via its effect on
ferroportin, the only known iron export protein. Cytokine-induced synthesis of
hepcidin plays a crucial role in macrophage iron retention, which underlies the
anemia of inflammation by limiting the availability of iron for erythroid
progenitor cells. Patients with anemia of inflammation display an impaired
response to erythropoietin (EPO). The compound is a 44-nucleotide L-RNA
oligonucleotide linked to 40 kDa PEG. Preclinical studies have demonstrated that
this compound inhibits IL-6 induced anemia in monkeys and has similar
pharmacokinetics to other Spieglemer® compounds. The compound can be
administered intravenously or subcutaneously. NOXXON receives grant support
within the program KMU-innovativ from the German Federal Ministry of Education
and Research (BMBF) for the preclinical development and the first-in-human
clinical trial with NOX-H94. 

Gary J. Vanasse and Nancy Berliner (2010) Anemia in Elderly Patients: An
Emerging Problem for the 21st Century, Hematology, 2010:271-5).
Guenter Weiss, M.D., and Lawrence T. Goodnough, M.D., (2005) Anemia of Chronic
Disease, N Engl J Med 2005; 352:1011-1023.

Emmanuelle Delabre
T: +49-30-726247-100

College Hill Life Sciences
Dr. Robert Mayer
T: +49 (0)89 57001806

Further inquiry note:
Marco Scheidler
Tel.: +49 (0) 3641 573-3600

end of announcement                               euro adhoc 

company:     Deutsche Effecten- und Wechsel-Beteiligungsges. AG
             Leutragraben 1
             D-07743 Jena
phone:       +49 (0)3641 573 3600
FAX:         +49 (0)3641 573 3610
sector:      Financial & Business Services
ISIN:        DE0008041005
stockmarkets: free trade: Berlin, Stuttgart, München, Open Market / Entry
             Standard: Frankfurt 
language:   English

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