Aton Pharma Inc announced that enrollment has begun in a phase I clinical trial of SAHA in patients with advanced leukemias, including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphocytic leukemia (ALL), and chronic lymphocytic leukemia (CLL), as well as myelodysplastic syndrome (MDS). SAHA is an inhibitor of histone deacetylase (HDAC). The trial will be conducted at The University of Texas M. D. Anderson Cancer Center in Houston.
This open-label study is being conducted to establish a safety profile and dosing schedule in adult patients with advanced leukemias or myelodysplastic syndrome. A secondary objective of the trial is to evaluate SAHA's anti-tumor activity in this patient population. The biological effects of SAHA in peripheral mononuclear cells and bone marrow blast cells from some patients will also be examined. It is expected that approximately 20-30 patients will be enrolled in the trial.
SAHA is currently being studied in two Phase II trials, one in patients with cutaneous T cell lymphoma (CTCL) or peripheral T-cell lymphoma (PTCL) and another in patients with recurrent or metastatic squamous cell cancer of the head and neck (SCCHN).
"We continue to be encouraged from the results of our clinical trials on SAHA. We are expanding the clinical program because we believe that SAHA may be therapeutically beneficial in a variety of cancers," stated Nicholas G. Bacopoulos, President and CEO of Aton Pharma.
"We are excited about the initiation of this Phase I leukemia trial, as it allows us to study the drug in a different patient population. We hope that SAHA will become an effective therapy for leukemia patients in the future," stated Carolyn M. Paradise, Senior Vice President and Chief Medical Officer at Aton.