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

Good safety and pharmacodynamic profile and additional good
subcutaneous bioavailability

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Company Information

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: edelabre@noxxon.com

Ende der Mitteilung euro adhoc
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ots Originaltext: Deutsche Effecten- und Wechsel-Beteiligungsges. AG (DEWB)
Im Internet recherchierbar: http://www.presseportal.de

Further inquiry note:

Marco Scheidler

Tel.: +49 (0) 3641 573-3600

E-Mail: marco.scheidler@dewb-vc.com

Branche: Financial & Business Services
ISIN: DE0008041005
WKN: 804100
Index: CDAX, Classic All Share, Prime All Share
Börsen: Frankfurt / regulated dealing/prime standard
Berlin / free trade
Stuttgart / free trade
München / free trade