EANS-News: DEWB Investment Holding NOXXON Announces Initiation of First-in-Human Clinical Trial with Hematopoietic Stem Cell Mobilizing Spiegelmer® NOX-A12

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Company Information

Berlin, Germany, November 02, 2009 (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 initial dosing of healthy volunteers
in a first-in-human clinical trial with Spiegelmer® NOX-A12. NOX-A12
is NOXXON´s second drug candidate entering the clinical stage of
development within only five months.

The Phase I program is currently being conducted in Germany following
review and approval of the Clinical Trial Application by the Federal
Institute for Drugs and Medical Devices (Bundesinstitut für
Arzneimittel und Medizinprodukte, BfArM). This single center study is
designed to evaluate the safety, tolerability, pharmacokinetics, and
pharmacodynamics in up to 42 individuals, following intravenous
administration of the hematopoietic stem cell (HSC) mobilizing
Spiegelmer® NOX-A12. Further information about this 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 data, we strongly
believe that, NOX-A12 has the potential to become an improved
alternative for hematopoietic stem cell mobilization. Our goal is to
have NOX-A12 approved by 2014. In this ongoing trial we are expecting
to see a good safety profile and to gain initial efficacy data that
will further validate the value of the Spiegelmer® technology for the
drug development in areas with high unmet medical need."

NOX-A12 binds and neutralizes the chemokine Stromal Cell-Derived
Factor-1 (SDF-1, also known as CXCL12), a key regulatory element in
the homing and retention of HSCs in the bone marrow. Mobilized HSCs
can be collected by leukapheresis, a process that is generally
preferred to invasive bone marrow harvesting. NOXXON´s pre-clinical
data indicate that the efficacy and pharmacokinetic properties of
NOX-A12 may lead to a simpler and more effective HSC mobilization
procedure compared to current practice.

The results obtained in this Phase I clinical trial will form the
basis for the Phase II program to be conducted by mid 2010 in
patients with mMultiple mMyeloma or non-Hodgkin´s Llymphoma
undergoing autologous stem cell transplantation.

About NOX-A12 NOX-A12 mobilizes hematopoietic stem cells from the
bone marrow by disrupting the SDF-1 gradient that normally attracts
them to their niches. Studies in animal models demonstrate that
treatment with a single dose of Spiegelmer® NOX-A12 significantly
mobilizes hematopoietic progenitor cells in a dose dependent manner.
NOXXON receives grant support 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 Hematopoietic Stem Cell Transplantation Hematopoietic stem cell
transplantation is considered the treatment of choice for many
patients with severe malignant or non-malignant, acquired or
congenital disorders of the hematopoietic system or for patients with
chemosensitive, radiosensitive or immunosensitive tumors. Better
management of the patients, improved supportive care, increased donor
pools and novel conditioning regimes have extended its use to new
patient categories and new disease conditions.

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,
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 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.
Website: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: 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
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Berlin / free trade
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