Deutsche Effecten- und Wechsel-Beteiligungsges. AG

EANS-News: DEWB Investment Holding NOXXON Pharma AG Initiates Phase IIa Trial of anti-CXCL12/SDF-1 Spiegelmer® NOX-A12 in Second Oncology Indication: Multiple Myeloma

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Company Information


Jena/Berlin, Germany - 26 September 2012 (euro adhoc) - NOXXON Pharma today
announced the treatment of the first cohort of three multiple myeloma (MM)
patients in a Phase IIa clinical trial of its anti-CXCL12/SDF-1 (CXC chemokine
ligand 12 / Stromal Cell-Derived Factor-1) Spiegelmer® NOX-A12. CXCL12 signaling
has been shown to play an important role in the pathophysiology of MM,
especially in the interaction of MM cells with the bone marrow microenvironment.
By inhibiting this interaction NOX-A12 sensitizes the cancer cells to
chemotherapy.

This is the third Phase IIa trial that NOXXON has started this year following
the NOX-E36 Phase IIa for the treatment of diabetic nephropathy in June and the
NOX-A12 Phase IIa for the treatment of Chronic Lymphocytic Leukemia in July.

MM is a hematologic or blood cancer that develops in the bone marrow in which
normal antibody-producing cells transform into malignant myeloma. The growth of
the cancer cells in the bone marrow blocks production of normal blood cells and
antibodies, and also causes lesions that weaken the bone. According to the US
National Cancer Institute (NCI), MM is the second most common blood cancer in
the United States and accounts for approximately one percent of all cancers.

NOXXON's multi-center, open-label, uncontrolled study will be conducted in
Europe on 28 relapsed MM patients who were all previously treated for their
cancer. The patients will receive NOX-A12 in combination with a background
therapy of Velcade®/bortezomib and dexamethasone (VD). Combination treatment
with NOX-A12 and VD will occur in 8 cycles of 21 days, with a follow-up period
of one year. Each patient will receive up to three different doses of NOX-A12 as
part of an individualized dose titration. The primary efficacy endpoint of the
study will be the overall response rate, which includes patients with complete
and partial responses to therapy. NOXXON expects interim results to be available
by the end of 2012. 

Although VD is one of the established therapies for MM, there remains
significant need for improved therapy in relapsed patients. Recent publications
indicate that the complete response rate for VD therapy of relapsed/refractory
MM is approximately 17%.

NOX-A12 is the only anti-cancer agent in active clinical development that
neutralizes CXCL12, thereby resulting in a complete block of CXCL12 signaling
through its two receptors, CXCR4 and CXCR7. Competing agents currently in
clinical trials act at the receptor level and only inhibit CXCR4.

Based on information from the NCI, the American Cancer Society and the GLOBOCAN
database, NOXXON estimates that there are approximately 100,000 MM patients
requiring treatment every year in the combined markets of the EU-5 (France,
Germany, Italy, Spain and the United Kingdom), Japan and the United States.

About NOXXON Pharma AG 
NOXXON Pharma is a biopharmaceutical company pioneering the development of a new
class of proprietary therapeutics called Spiegelmers. Spiegelmers are the
chemically synthesized, non-immu-nogenic alternative to antibodies. NOXXON has a
diversified portfolio of clinical-stage Spiegelmer® therapeutics:

- NOX-E36 is an anti-CCL2/MCP-1 (C-C chemokine ligand 2 / Monocyte
Chemoattractant Pro-tein 1) Spiegelmer® currently in a Phase IIa study in
patients with type 2 diabetes with albuminuria. CCL2 is a proinflammatory
chemokine involved in recruitment of immune cells to in-flamed tissues.

- NOX-A12 is an anti-CXCL12/SDF-1 (CXC chemokine ligand 12 / Stromal
Cell-Derived Factor 1) Spiegelmer® that is currently in Phase IIa studies in two
hematological cancers, multiple myeloma (MM) and chronic lymphocytic leukemia
(CLL). CXCL12 is a chemokine mediator of tumor invasion, metastasis, and
resistance to chemotherapy.

- NOX-H94 is an anti-hepcidin Spiegelmer® that has completed a comprehensive
single and multiple ascending dose Phase I study and a Phase I endotoxin
challenge study, designed to test the ability of NOX-H94 to block
hepcidin-mediated hypoferremia in healthy volunteers. A Phase IIa study of
NOX-H94 in myeloma and lymphoma patients with anemia is planned to start in the
second half of 2012. Hepcidin is the key regulator of iron metabolism and a
mediator of iron restriction in anemia of chronic disease.

The Spiegelmer® platform provides the company with powerful and unique discovery
capabilities, which have generated a number of additional leads under
preclinical investigation. Located in Berlin, Germany, NOXXON is a well-financed
mature biotech company with a strong syndicate of international investors,
approx. 60 employees and a highly experienced management team. For more
information, please visit: www.noxxon.com

About NOX-A12
NOX-A12 specifically binds and neutralizes CXCL12/SDF-1 (CXC chemokine ligand 12
/ Stromal Cell-Derived Factor-1), a chemokine which activates and attracts
immune and non-immune cells including stem cells from the bone marrow. CXCL12
binds with high affinity to two chemokine receptors, CXCR4 and CXCR7. The CXCL12
/ CXCR4 / CXCR7 axis has been shown to play a role in stem cell mobilization,
vasculogenesis, tumor growth and metastasis. Inhibition of CXCL12 binding to its
receptors sensitizes tumor cells to chemotherapy and in some solid tumors,
prevents invasion and metastasis, suggesting that NOX-A12 in combination with
chemotherapy could be beneficial in the treatment of various cancers. 

NOX-A12 has shown promising activity in models of both hematological and solid
tumors in addition to models of stem cell mobilization. NOXXON's collaborators
have shown that in multiple myeloma models NOX-A12 detached myeloma cells from
stromal cells and sensitized them to killing by Velcade®/bortezomib both in
vitro and in vivo. NOX-A12 has also been shown to inhibit chemotaxis of
patient-derived primary CLL cells towards higher concentrations of CXCL12 and to
have distinct properties from CXCR4 antagonists. In an animal model of
glioblastoma, NOX-A12 treatment resulted in a significant extension of lifespan
of animals when used in combination with radiation therapy.

In Phase I studies with healthy volunteers, single doses of NOX-A12 up to 10.8
mg/kg and daily doses up to 2 mg/kg for five days were found to be safe and well
tolerated and resulted in dose-dependent mobilization of white blood cells and
CD34+ hematopoietic stem cells as predicted by preclinical studies. 

NOXXON received grant support within the program "KMU-innovativ" from the German
Federal Ministry of Education and Research (BMBF) for the preclinical program
and the Phase I clinical trials with NOX-A12. 

Further information about the ongoing NOX-A12 Phase IIa clinical trials is
available at ClinicalTrials.gov: relapsed MM (ID: NCT01521533) and relapsed CLL
(ID: NCT01486797).

Contact:

NOXXON Pharma AG     
Emmanuelle Delabre 
T: +49-30-726247-100 
edelabre@noxxon.com


College Hill Life Sciences
Dr. Robert Mayer
T: +49-89-57001806
robert.mayer@collegehill.com


Further inquiry note:
Marco Scheidler
Tel.: +49 (0) 3641 3100030
E-Mail: marco.scheidler@dewb-vc.com

end of announcement                               euro adhoc 
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company:     Deutsche Effecten- und Wechsel-Beteiligungsges. AG
             Fraunhoferstraße 1
             D-07743 Jena
phone:       +49 (0)3641 3100030
FAX:         +49 (0)3641 3100040
mail:     ir@dewb-vc.com
WWW:      http://www.dewb-vc.com
sector:      Financial & Business Services
ISIN:        DE0008041005
indexes:     
stockmarkets: free trade: Berlin, München, Stuttgart, Open Market / Entry
             Standard: Frankfurt 
language:   English
 



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