Positive final data from Phase 2 study of ISTODAX presented

Dec 6 2009

Gloucester Pharmaceuticals announced today the presentation of positive final data from a Phase 2 study of ISTODAX^® (romidepsin) in peripheral T-cell lymphoma (PTCL) conducted by the National Cancer Institute (NCI) at the 51^st American Society of Hematology (ASH) Annual Meeting being held in New Orleans, LA. Gloucester is currently conducting a registration trial in PTCL and anticipates data from this study in 2010. ISTODAX is a member of a new class of cancer drugs known as histone deacetylase (HDAC) inhibitors and has been approved by the U.S. Food and Drug Administration for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. ISTODAX is not approved for the treatment of PTCL or other indications.

"We continue to be extremely encouraged by the results from this NCI study of ISTODAX in patients with PTCL," commented Dr. Jean Nichols, President and Chief Operating Officer of Gloucester Pharmaceuticals. "The sustained duration of response with a median of 10.3 months and the complete responses seen in the study suggests that ISTODAX may meet a significant unmet medical need in this relapsed, refractory patient population and reinforces the potential for ISTODAX to become a meaningful addition to the treatment landscape for PTCL."

"We’re very pleased that the progress in the ISTODAX development program continues to be consistent with our expectations for a broader product profile,” said Alan Colowick, President and Chief Executive Officer of Gloucester Pharmaceuticals. “Gloucester has reached its accrual goal in the PTCL registration trial of ISTODAX and we anticipate filing a supplemental New Drug Application for ISTODAX for the treatment of PTCL in 2010."

The Phase 2 study of ISTODAX in PTCL is sponsored by the NCI under a Cooperative Research and Development Agreement (CRADA) with Gloucester and was conducted in the United States and Australia. In a poster presentation entitled, “Final Results of a Phase 2 NCI Multicenter Study of Romidepsin in Patients with Relapsed Peripheral T-Cell Lymphoma (PTCL)” Dr. Susan Bates of the National Cancer Institute described the results for 47 patients enrolled in the study. The treatment schedule was 14 mg/m² of ISTODAX infused on days one, eight and 15 every 28 days. The mean number of prior therapies for patients enrolled in the study is five (range one to 14) including 17 (36%) patients who had received a stem cell transplant. The overall response rate (complete response + partial response) is 38% (18/47) and the median duration of response is 10.3 months (range of 1.8 months to 72.4+ months). Five patients continue to respond to treatment at the time of this presentation. 15% (7/47) of patients experienced a complete response. Overall the adverse event profile in the study for patients with PTCL was consistent with that previously reported. The most frequent drug-related AEs were generally mild and included nausea (68%, 4% ≥grade 3), cardiovascular/general other (68%, 0% ≥grade 3), thrombocytopenia (66%, 28% ≥grade 3), fatigue (64%, 13% ≥grade 3), neutropenia (62%, 40% ≥grade 3), leukocyte (total WBC decreased) (53%, 43% ≥grade 3).

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