NOXXON Pharma today announced the treatment of the first cohort of three
chronic lymphocytic leukemia (CLL) patients in a Phase IIa clinical
trial of its NOX-A12 anti-CXCL12/SDF-1 (CXC Chemokine Ligand 12 /
Stromal Cell-Derived Factor-1) Spiegelmer®. CXCL12 signaling
has been shown to play an important role in the pathophysiology of CLL,
especially in the interaction of leukemic cells with the tissue
microenvironment. The therapeutic concept of NOX-A12 is to inhibit such
tumor-supporting interactions and thereby sensitize CLL cells to
NOXXON's multi-center, open-label, uncontrolled study will be conducted
on 33 relapsed CLL patients, all of whom were previously treated for
CLL. The patients will receive NOX-A12 in combination with a background
therapy of bendamustine and rituximab (BR). Combination treatment with
NOX-A12 and BR will occur in 6 cycles of 28 days, with a follow-up
period of 30 months. 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 complete remission (CR)
rate. NOXXON expects interim results to be available at the upcoming
American Society of Hematology Annual Meeting in Atlanta, Georgia which
will be held from 8-11 December, 2012.
Although BR is one of the established therapies for CLL, there remains
significant need for improved therapy in relapsed patients. Recent
publications indicate that the complete remission rate for BR therapy of
relapsed CLL is approximately 15%.
NOX-A12 is the only anti-cancer agent in active clinical development
that neutralizes the CXCL12 ligand, thereby resulting in a complete
block of CXCL12 signaling through its two receptors, CXCR4 and CXCR7.
Competing agents act at the receptor level and only inhibit one of the
two CXCL12 receptors.