NOXXON Announces Initiation of First-in-Human Clinical Trial with Hematopoietic Stem Cell Mobilizing Spiegelmer® NOX-A12

* Reuters is not responsible for the content in this press release.

Mon Nov 2, 2009 4:55am EST

BERLIN--(Business Wire)--
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 Multiple Myeloma
or non-Hodgkin`s Lymphoma 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

NOXXON Pharma AG
Emmanuelle Delabre
Phone: + 49-30-726247-100
FAX: + 49-30-726247-225
Email: edelabre@noxxon.com



Copyright Business Wire 2009

Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.