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
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