EANS-News: DEWB investment holding NOXXON Pharma AG announces excellent preliminary phase I trial results for Spiegelmer® NOX-E36

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Utl.: Good safety and pharmacodynamic profile and additional good subcutaneous
bioavailability =

Berlin, Germany, 12 October 2009 (euro adhoc) - NOXXON Pharma AG, the
biopharmaceutical company focusing on the development of novel drugs based on
its unique proprietary Spiegelmer® technology, today announced successful
completion of the first phase I trial with its anti-inflammatory Spiegelmer®
NOX-E36. This drug candidate will be developed for the treatment of
complications of type 2 diabetes, preferentially diabetic nephropathy, but also
others.

The phase I study, conducted in the United Kingdom, was performed to evaluate
the safety, tolerability, pharmacokinetics and pharmacodynamics of the chemokine
inhibitor NOX-E36 in 72 healthy volunteers. A double-blind, placebo-controlled,
single ascending dose study design was used to investigate escalating
intravenous doses, the bioavailability of subcutaneous doses and potential
gender differences.

Preliminary results show NOX-E36 to be safe and well tolerated at all dose
levels in both the intravenous and subcutaneous groups. NOX-E36 showed
dose-linear pharmacokinetics, leading to plasma concentrations well above those
known to be effective in animal models. Pharmacodynamic evaluation indicates a
dose-dependent decrease of peripheral blood monocytes, consistent with the mode
of action of NOX-E36 - neutralization of chemokine monocyte chemoattractant
protein-1 (MCP-1). This protein is a specific target in the inflammatory
reaction cascade that causes recruitment of monocytes to sites of inflammation.
It has recently been introduced as "adipokine" playing an important role in
obesity and complications of type 2 diabetes. Its inhibition is thus anticipated
to be of benefit for type 2 diabetes patients.

In addition, NOX-E36 showed excellent bioavailability after subcutaneous
administration. This fact should make it possible to achieve a dosing regimen
with at least once weekly administration. Final results and analysis for this
phase I trial are expected by early 2010.

The results of this phase I study will be instrumental in the design of the
upcoming multiple dose studies in healthy volunteers and non-insulin dependent
diabetic patients with multiple complications. The recruitment phase for these
studies will begin in early 2010.

Dr Frank Morich, CEO of NOXXON Pharma AG, commented: "The preliminary results of
this phase I study are impressive and show that Spiegelmers® have the potential
to become a novel class of broadly applicable therapeutic agents addressing
large areas of unmet medical need. They also indicate that Spiegelmers® can be
applied in convenient dosing regimens. In the meantime our other drug candidates
are advancing rapidly towards clinical development."

About NOXXON
Berlin-based NOXXON Pharma AG is a clinical stage biotechnology company focusing
on the development of Spiegelmers® for the treatment of inflammatory diseases
and haematological indications. NOXXON is in possession of a broad patent estate
and a readily scalable GMP production. In addition to its in-house programs
NOXXON discovers and develops Spiegelmers® in collaboration with partners from
the pharmaceutical industry, including Eli Lilly, Hoffmann La-Roche and Pfizer.
The business strategy of NOXXON is to broaden this range of collaborations
through co-development and licensing agreements for the proprietary clinical and
pre-clinical products as well as technology-based multi-target partnerships.
Currently the company has one compound in clinical development. The declared
goal of NOXXON is to establish the Spiegelmer® drug discovery platform as the
leading scaffold technology to deliver non-polypeptide-based chemical entities
with superior properties.
NOXXON´s main investors are TVM Capital, Sofinnova Partners, Edmond de
Rothschild Investment Partners, Deutsche Effecten- und
Wechsel-Beteiligungsgesellschaft (DEWB), Seventure Partners, Dow Venture
Capital, Dieckell Group, FCP OP MEDICAL BioHealth-Trends, IBG
Risikokapitalfonds, VC Fonds Berlin, and others.

About Spiegelmers®
Spiegelmers® (L-aptamers) are chemical entities based on synthetic mirror-image
oligonucleotides which are highly selective for their pharmacological target and
potent inhibitors of target function. They combine the benefits of small
molecule drugs and biopharmaceuticals. Due to their unique mirror image
configuration Spiegelmers® are not metabolized and do not hybridize with native
nucleic acids. Spiegelmers® also do not activate the innate immune response via
toll-like receptors and showed an exceptionally favourable immunogenicity
profile in pre-clinical testing.

About NOX-E36
NOX-E36 is a new therapeutic modality that specifically targets the
pro-inflammatory chemokine monocyte chemoattractant protein-1 (MCP-1), which is
also known as CCL2. Previously completed studies in various animal models
demonstrate that treatment with Spiegelmer® MCP-1 antagonists significantly
delays the decline in kidney function as well as disease progression. The
preclinical profiling and first-in-human enabling studies were supported by a
grant of the German Federal Ministry of Education and Research (BMBF).

Contakt:
Emmanuelle Delabre
NOXXON Pharma AG
Max-Dohrn-Strasse 8-10
10589 Berlin, Germany
Phone: + 49-30-726247-100
Fax: + 49-30-726247-225
Email: [email protected]

Further inquiry note:
Marco Scheidler
Tel.: +49 (0) 3641 573-3600
E-Mail: [email protected]
Ende der Mitteilung euro adhoc
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issuer: Deutsche Effecten- und Wechsel-Beteiligungsges. AG
Leutragraben 1
D-07743 Jena
phone: +49 (0)3641 573 3600
FAX: +49 (0)3641 573 3610
mail: [email protected]
WWW: http://www.dewb-vc.com
sector: Financial & Business Services
ISIN: DE0008041005
indexes: CDAX, Classic All Share, Prime All Share
stockmarkets: regulated dealing/prime standard: Frankfurt, free trade: Berlin,
Stuttgart, München
language: English

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