Gloucester Pharmaceuticals announced today the presentation of positive
data from an analysis of ISTODAX® (romidepsin) in a subset of
patients from Gloucester’s registration study in cutaneous T-cell
lymphoma (CTCL) at the 51st American Society of Hematology
(ASH) Annual Meeting being held in New Orleans, LA. This analysis is an
assessment of patients with CTCL who—in addition to skin disease and
potential lymph node and visceral involvement—also had blood
involvement. Blood involvement is characterized as having greater than
five percent circulating Sézary (malignant) cells and is typically
associated with advanced stage, aggressive disease. ISTODAX is a member
of a new class of cancer drugs known as histone deacetylase (HDAC)
inhibitors and was recently approved by the U.S. Food and Drug
Administration for the treatment of cutaneous T-cell lymphoma in
patients who have received at least one prior systemic therapy.
“CTCL that includes blood involvement represents a major therapeutic
challenge and the results of this analysis suggest that ISTODAX may help
address a treatment void for these patients,” said Dr. Youn Kim, an
investigator in studies of ISTODAX and Professor, Department of
Dermatology and Director, Multidisciplinary Cutaneous Lymphoma Program,
Stanford Cancer Center, Stanford, CA. “In this subset of 37 patients
with blood involvement, the response rate is consistent with the
response rate from the overall population of 96 patients in the
registration trial. Additionally, the rapid and sustained reduction in
Sézary counts observed in many patients with a higher blood tumor
burden, which is typically associated with advanced stage, more
aggressive disease, is noteworthy."