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Subtitle: Study to include healthy volunteers and diabetic patients
Berlin, Germany, 7 July 2010 (euro adhoc) - 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.
Further inquiry note:
Marco Scheidler
Tel.: +49 (0) 3641 573-3600
E-Mail: marco.scheidler@dewb-vc.com
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: ir@dewb-vc.com
WWW: http://www.dewb-vc.com
sector: Financial & Business Services
ISIN: DE0008041005
indexes:
stockmarkets: free trade: Berlin, Stuttgart, München, Open Market / Entry Standard:
Frankfurt
language: English
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