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
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
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.