--38% overall response rate and 10.3 month median duration of response--
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 51st 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).
About ISTODAX®
ISTODAX, a novel histone deacetylase (HDAC) inhibitor, 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. For full prescribing information, please visit www.ISTODAX.com. Gloucester is currently conducting a registration trial in peripheral T-cell lymphoma (PTCL) and additional studies of ISTODAX are being conducted in other hematologic and solid tumors. ISTODAX is not approved for the treatment of PTCL or other indications.
Important Safety Information
ISTODAX® is indicated for treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.
Warnings and Precautions
Due to the risk of QT prolongation,
potassium and magnesium should be within the normal range before
administration of ISTODAX.
Treatment with ISTODAX can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia; therefore, these hematological parameters should be monitored during treatment with ISTODAX, and the dose should be modified, as necessary.
Several treatment-emergent morphological changes in ECGs including T-wave and ST-segment changes have been reported in clinical studies. The clinical significance of these changes is unknown. In patients with congenital long QT syndrome, patients with a history of significant cardiovascular disease, and patients taking anti-arrhythmic medicines or medicinal products that lead to significant QT prolongation, appropriate cardiovascular monitoring precautions, such as the monitoring of electrolytes and ECGs should be considered.
Based on its mechanism of action, ISTODAX may cause fetal harm. Woman should avoid becoming pregnant while being treated with ISTODAX and pregnant women should be advised of the potential harm to the fetus.
ISTODAX binds to estrogen receptors. Women of childbearing potential should be advised that ISTODAX may reduce the effectiveness of estrogen-containing contraceptives.
Adverse Reactions
Safety data was available and evaluated in
185 patients with CTCL in two clinical trials. Adverse reactions are
presented separately for each study due to methodological differences
between the studies. The most common reported adverse reactions in Study
1 were nausea (56%), fatigue (53%), infections (46%), vomiting (34%),
and anorexia (23%) and in Study 2 were nausea (86%), fatigue (77%),
anemia (72%), thrombocytopenia (65%), ECG T-wave changes (63%),
neutropenia (57%), and lymphopenia (57%). Most of the adverse reactions
were reported to be mild or moderate in severity. Most deaths in the
studies were due to disease progression. Discontinuation due to an
adverse event occurred in 21% of patients in Study 1 and 11% in Study 2.
Serious adverse reactions reported in > 2% of patients in Study 1 were
infection, sepsis, and pyrexia. In Study 2, serious adverse reactions in
> 2% of patients were infection, supraventricular arrhythmia,
neutropenia, fatigue, edema, central line infection, ventricular
arrhythmia, nausea, pyrexia, leukopenia, and thrombocytopenia.
Drug Interactions
Prothrombin time (PT) and International
Normalized Ratio (INR) should be carefully monitored in patients
concurrently administered ISTODAX and Coumadin derivatives.
Co-administration of strong CYP3A4 inhibitors may increase concentrations of ISTODAX and should be avoided.
Co-administration of potent CYP3A4 inducers may decrease concentrations of ISTODAX and should be avoided.
Caution should be exercised if ISTODAX is administered with drugs that inhibit P-glycoprotein.
Use in Specific Patient Populations
Patients with moderate
and severe hepatic impairment or end-stage renal disease should be
treated with caution.
For additional important safety information, please see full prescribing information for ISTODAX at www.ISTODAX.com or call 1-866-223-7145.
About Gloucester Pharmaceuticals
Gloucester Pharmaceuticals acquires clinical-stage oncology drug candidates and advances them through regulatory approval and commercialization. The Company's first candidate, ISTODAX® (romidepsin), a novel histone deacetylase (HDAC) inhibitor, is FDA approved for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. Gloucester is currently conducting a registration trial in peripheral T-cell lymphoma (PTCL) and anticipates data from this study in 2010. In addition, the Company is continuing further investigation of ISTODAX in other hematologic indications and solid tumors. For more information, please visit www.gloucesterpharma.com.
Contacts:
MacDougall Biomedical Communications
Sarah Cavanaugh/Cory Tromblee,
781-235-3060
scavanaugh@macbiocom.com
ctromblee@macbiocom.com