EANS-News: DEWB Investment Holding NOXXON to Initiate Phase Ib Clinical Trial of MCP-1 Inhibitor NOX-E36
Geschrieben am 07-07-2010 |
Study to include healthy volunteers and diabetic patients
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Company Information
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.
end of announcement 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
Börsen: Berlin / free trade
Stuttgart / free trade
München / free trade
Frankfurt / Open Market / Entry Standard
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