EANS-News: DEWB Investment Holding NOXXON Initiates Phase IIa of Anti-Hepcidin Spiegelmer® NOX-H94

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Subtitle: Anemia of Chronic Disease Study is Fourth Phase II
Initiated by NOXXON in 2012

Company Information

Berlin, 04 December 2012 (euro adhoc) - NOXXON Pharma today announced
the treatment of the first patients in a Phase IIa clinical trial of
its anti-hepcidin Spiegelmer® NOX-H94 to treat anemia associated with
chronic disease. This Phase IIa study was initiated following the
successful completion of the clinical Phase I program, data from
which will be presented at the upcoming ASH (American Society of
Hematology) meeting in Atlanta, Georgia, 8-11 Dec 2012. The Phase I
program consisted of a comprehensive single and multiple ascending
dose study in healthy volunteers and a subsequent human
pharmacodynamic study to assess the ability of NOX-H94 to prevent
endotoxin-induced hypoferremia in healthy subjects. This endotoxemia
study delivered the first clinical evidence that NOX-H94 is capable
of neutralizing high levels of hepcidin in humans and maintaining
higher serum iron concentrations relative to subjects receiving
placebo.

NOX-H94 is the third Spiegelmer® to enter Phase II studies and this
study is the fourth Phase IIa trial that NOXXON has started this
year. The other Phase IIa studies initiated in 2012 include the
NOX-E36 Phase IIa for the treatment of diabetic nephropathy, the
NOX-A12 Phase IIa for the treatment of Chronic Lymphocytic Leukemia,
and the NOX-A12 Phase IIa for the treatment of Multiple Myeloma.

Excessive concentrations of the peptide hormone hepcidin, which is
also called the master regulator of iron homeostasis, occur in some
chronic diseases such as cancer, renal disease, or inflammatory
diseases. These high hepcidin levels lead to iron restriction, also
known as functional iron deficiency: a condition in which iron is
blocked inside its cellular stores and is thus unavailable for
hemoglobin synthesis. This condition, over time, results in anemia of
chronic disease. NOX-H94 inhibits this pathological mechanism by
binding and inactivating hepcidin.

The NOX-H94 Phase IIa study is being conducted to investigate the
hypothesis that inhibition of hepcidin can raise hemoglobin levels in
patients with anemia of chronic disease. The four-week repeated-dose
multi-center study will be conducted in Europe in anemic patients
with cancer. An open-label pilot phase will be followed by a 3-arm
randomized, double-blind, placebo-controlled main phase comparing two
different dose-regimens of NOX-H94 with placebo.

Hepcidin inhibitors such as NOX-H94 offer the potential to provide a
targeted treatment alternative for anemia of chronic disease and to
avoid some of the disadvantages of the existing unspecific therapies
which are often given at supra-physiological doses:
erythropoiesis-stimulating agents (ESAs), i.v. iron, and blood
transfusions:

- the potential risks of ESAs in the treatment of patients with
cancer and chronic kidney disease are documented in the black box
warning required by the US FDA and include increased risk of tumor
progression or recurrence;

- use of i.v. iron has increased in response to concerns with ESAs;
but this therapy is limited by the potential occurrence of iron
overload, in addition administration of i.v. iron leads to a
counter-productive increase in hepcidin;

- blood transfusions also add iron to the body and in addition bring
the risks of transmissible diseases and immunosuppression.

NOX-H94 is the first hepcidin inhibitor to reach Phase II.

Based on information from the GLOBOCAN database and scientific
publications on rates and types of anemia in cancer and chronic
kidney disease (CKD) patients, NOXXON estimates that there are
approximately 230,000 cancer patients and 3.6 million CKD patients
requiring treatment for anemia of chronic disease every year that
could potentially benefit from a hepcidin inhibitor in the combined
markets of the EU-5 (France, Germany, Italy, Spain and the United
Kingdom), Japan and the United States.

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, an anti-CCL2/MCP-1 (C-C chemokine ligand 2 / Monocyte
Chemoattractant Protein 1) Spiegelmer®, is currently in a Phase IIa
study in patients with type 2 diabetes with albuminuria. CCL2 is a
pro-inflammatory chemokine involved in the recruitment of immune
cells to inflamed tissues.

- NOX-A12, an anti-CXCL12/SDF-1 (CXC chemokine ligand 12 / Stromal
Cell-Derived Factor 1) Spiegelmer®, is currently in Phase IIa studies
in two hematological cancers, multiple myeloma (MM) and chronic
lymphocytic leukemia (CLL). CXCL12 is a chemokine mediator of tumor
invasion, metastasis, and resistance to therapy.

- NOX-H94, an anti-hepcidin Spiegelmer®, is currently in a Phase IIa
study in cancer patients with anemia. Hepcidin is the key regulator
of iron metabolism and responsible for the iron restriction leading
to 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, and approx. 60
employees. For more information, please visit: www.noxxon.com

About NOX-H94 & Anemia of Chronic Disease NOX-H94 is a Spiegelmer®
compound targeting 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 chronic disease by limiting
the availability of iron for erythroid progenitor cells. Patients
with anemia of chronic disease display an impaired response to
erythropoietin (EPO). The NOX H94 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 Spiegelmer®
compounds. The compound can be administered intravenously or
subcutaneously.

NOXXON received grant support within the program KMU-innovativ from
the German Federal Ministry of Education and Research (BMBF) for the
preclinical and early clinical development of NOX-H94.

Further information about the ongoing NOX-H94 Phase IIa clinical
trial is available at ClinicalTrials.gov: ID: NCT01691040.

Contact:

NOXXON Pharma AG
Emmanuelle Delabre
T: +49-30-726247-100
edelabre@noxxon.com

College Hill Life Sciences
Melanie Toyne Sewell, Cora Kaiser
T: +49-89-57001806
noxxon@collegehill.com

About DEWB Deutsche Effecten- und Wechsel-Beteiligungsgesellschaft AG
(DEWB AG, ISIN: DE0008041005) is a listed private equity house that
specialises in young and established medium-sized companies. The
investment focus is on strong growth companies from the areas of
photonics and sensor systems as well as their fields of application
in automation and industrial engineering and related areas for which
DEWB provides support through shareholders' equity, expertise in
corporate development and its sector network. Since 1997 DEWB has
invested more than 360 million Euros in 55 companies and realized
more than 465 million Euros through 42 exits, eight of which were in
the form of IPOs. The company is located in Jena, one of the most
successful technology and science regions in Germany, with a long
tradition in the field of optical technologies and one of the most
important European centres for photonics.

Further inquiry note:
Marco Scheidler
Tel.: +49 (0) 3641 3100030
E-Mail: marco.scheidler@dewb.de

end of announcement euro adhoc
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company: Deutsche Effecten- und Wechsel-Beteiligungsges. AG
Fraunhoferstraße 1
D-07743 Jena
phone: +49 (0)3641 3100030
FAX: +49 (0)3641 3100040
mail: ir@dewb.de
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sector: Financial & Business Services
ISIN: DE0008041005
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