• 03.05.2010, 12:24:16
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EANS-News: DEWB Investment Holding NOXXON Announces the Completion of the First-in-Human Clinical Trial with Spiegelmer® NOX-A12

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Corporate news transmitted by euro adhoc. The issuer/originator is solely
responsible for the content of this announcement.
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Berlin, Germany, May 03, 2010 (euro adhoc) - NOXXON Pharma AG, the
biopharmaceutical company focusing on the development of novel drugs based on
its unique proprietary Spiegelmer® technology, announced today the successful
completion of the first-in-human clinical trial with Spiegelmer® NOX-A12.

This Phase I study was designed to evaluate the safety, tolerability,
pharmacokinetics, and pharmacodynamics in healthy individuals following
intravenous administration of the stromal cell-derived factor-1 (SDF-1)
antagonizing Spiegelmer® NOX-A12. Final data analysis demonstrated an excellent
safety and tolerability up to the highest tested dose of 10.8 mg/kg. In
addition, analysis by flow cytometry revealed a long lasting and dose dependent
mobilization of WBC and CD34 positive cells. The protocol also allowed that an
additional group of volunteers would be dosed and be receiving a leukapheresis
procedure if certain thresholds of circulating CD34 positive cells were reached,
to further characterize the mobilized cells. This study goal was achieved, too.
Further information about the clinical trial is available on
www.clinicaltrials.gov (ID: NCT00976378).

Dr. Frank Morich, Chief Executive Officer of NOXXON, commented: "Based on
exceptionally positive pre-clinical and clinical data, we strongly believe that
NOX-A12 has the potential to be developed for acute as well as chronic
indications in the area of hematological malignancies and/or solid tumors.
NOX-A12 is scheduled to enter a multiple dose Phase I clinical trial by mid of
2010, and phase II clinical testing soon thereafter."

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 CXCR4/SDF-1
axis has been shown to play a role in stem cell mobilization, vasculogenesis,
tumor growth and metastasis. Inhibition of the SDF-1 binding to CXCR4 sensitizes
tumor cells to chemotherapy suggesting that NOX A12 in combination with
chemotherapy could be beneficial in the treatment of various cancers.

NOX-A12 has been evaluated in models of stem cell mobilization, angiogenesis,
inflammation and lung and kidney injury. In these models NOX-A12 reduced
pathological angiogenesis and tissue remodeling. In preclinical safety and two
weeks toxicology studies NOX-A12 was safe and did not show any organ toxicity.
In particular NOX-A12 did not exert any immunotoxicity effects, such as
Toll-like receptor activation or changes in cytokine levels.

NOXXON receives grant support (Grant no. 0315118) within the program
"KMU-innovativ" from the German Federal Ministry of Education and Research
(BMBF) for the preclinical program and the first-in-human clinical trial with
NOX-A12.

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. Unlike conventional nucleic acids, Spiegelmers® do not activate
the innate immune response via toll-like receptors and they showed an
exceptionally favorable immunogenicity profile in pre-clinical testing.

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 hematological indications. NOXXON is in possession of a broad patent estate
and has access to 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 and Hoffmann
La-Roche. 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 two compounds in clinical
development. The declared goal of NOXXON is to establish its
oligonucleotide-based drug discovery platform (Spiegelmers®) as the leading
'scaffold' technology to create new chemical entities with superior properties.

NOXXON´s 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.

Webseite: http://www.noxxon.com

General contact:
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]
end of announcement 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
stockmarkets: free trade: Berlin, Stuttgart, München, regulated dealing/general
standard: Frankfurt
language: English

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