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EANS-News: DEWB Investment Holding NOXXON to Initiate Phase Ib Clinical Trial of MCP-1 Inhibitor NOX-E36

Berlin, Germany, 7 July 2010 (euro adhoc) -

Study to include healthy volunteers and diabetic patients
  Corporate news transmitted by euro adhoc. The issuer/originator is solely
  responsible for the content of this announcement.
Company Information
Subtitle: Study to include healthy volunteers and diabetic patients
NOXXON Pharma AG
announced today that it has permission to commence a multiple 
ascending dose study of its Monocyte Chemoattractant Protein-1 
(MCP-1) targeting anti-inflammatory Spiegelmer®, NOX-E36. NOXXON 
plans to develop NOX-E36 for the treatment of diabetic nephropathy 
and other diabetes related complications.
The double-blind, placebo controlled, Phase I study will evaluate the
safety, tolerability, pharmacokinetics and pharmacodynamics of the 
MCP-1 inhibitor NOX-E36 in four groups of subjects. The first group, 
composed of healthy volunteers, will receive NOX-E36 i.v. every other
day for 15 days. The three remaining groups, composed of type II 
diabetic patients, will receive ascending doses of NOX-E36 i.v. every
other day for 27 days.
Dr Frank Morich, CEO of NOXXON Pharma AG, commented: "The 
pharmacokinetic and pharmacodynamic data from diabetic patients who 
will be enrolled in this NOX-E36 study will guide NOXXON in choosing 
the doses and endpoints most likely to reveal the therapeutic 
potential of NOX-E36 in a Phase II program. Given the absence of 
existing therapies in the indications targeted by NOX-E36 the 
inclusion of diabetic patients is a crucial step in defining the best
path forward."
The NOX-E36 multiple ascending dose study is scheduled to begin 
treatment of the first group of subjects in August 2010. Further 
information about this clinical trial is available at 
www.clinicaltrials.gov (ID: NCT01085292).
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
Website: http://www.noxxon.com
About Spiegelmers® Spiegelmers® (L-stereoisomer RNA oligonucleotides)
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 favorable immunogenicity profile in 
pre-clinical testing.
About NOX-E36 NOX-E36 is a new Spiegelmer®-based therapeutic that 
specifically binds to and inhibits the pro-inflammatory chemokine 
monocyte chemoattractant protein-1 (MCP-1), which is also known as 
CCL2. Previously completed studies in animal models of diabetes and 
lupus nephritis demonstrate that treatment with Spiegelmer® MCP-1 
antagonists significantly delay decline in kidney function as well as
disease progression. The Phase I single ascending dose trial 
demonstrated NOX-E36 to be safe and well tolerated in healthy 
volunteers at all employed dose levels after both intravenous and 
subcutaneous routes of administration. Subcutaneous bioavailability 
of NOX-E36 was greater than 50%. An overall comparison between 
NOX-E36 and placebo treated subjects did not reveal any safety 
related differences. There were no clinically relevant effects on 
vital signs, ECG and laboratory parameters. NOX-E36 exhibited 
dose-linear pharmacokinetics, and the pharmacokinetic profile after 
subcutaneous administration suggests the possibility to maintain 
clinically relevant plasma levels with a once or twice weekly dosing 
regimen. Pharmacodynamic data showed a significant and dose-dependent
decrease in peripheral blood monocytes - the largest population of 
immune cells that carry the MCP-1 receptor. This effect is consistent
with inhibition of MCP-1, the mode of action of NOX-E36. The 
preclinical profiling and first-in-human enabling studies were 
supported by a grant of the German Federal Ministry of Education and 
Research (BMBF, grant no. 01GU0703).
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 possesses 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. Currently the 
company has two compounds in clinical development. NOXXON´s investors
are NGN Capital, 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.
end of announcement                               euro adhoc

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
Börsen: Berlin / free trade
Stuttgart / free trade
München / free trade
Frankfurt / Open Market / Entry Standard

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