• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Gloucester Pharmaceuticals Announces Presentation of Romidepsin Phase 1 Data in Multiple Solid Tumors at ASCO

Posted on: Monday, 2 June 2008, 09:19 CDT

Gloucester Pharmaceuticals today announced results from a Phase 1 study of romidepsin in combination with gemcitabine in patients with solid tumors. The results from the Phase 1 study showed that the combination was generally well tolerated and indicated that further investigation of romidepsin as a potential treatment in multiple cancer indications may be warranted. The results were presented at the American Society for Clinical Oncology (ASCO) Annual Meeting in Chicago, IL on June 1, 2008. Romidepsin is a novel, cyclic peptide, pan-HDAC inhibitor.

"The Phase 1 data demonstrated a favorable tolerability profile for the combination of romidepsin and gemcitabine, a standard chemotherapeutic agent, as a potential new course of treatment for solid tumors and hematological malignancies," commented Howard A. Burris, III, M.D., Chief Medical Officer of the Sarah Cannon Research Institute and the Lead Investigator of the trial. "Importantly, we have established the appropriate dosing regimen for this combination and look forward to potentially building on this platform in future studies."

"Based on the synergy established in preclinical models and the tolerability observed in this clinical study of romidepsin with gemcitabine, we believe this combination of agents offers a unique approach to clinically investigate a broad range of cancers, including both solid tumors and hematologic malignancies," commented Alan Colowick, MD, MPH, CEO of Gloucester Pharmaceuticals. "We recently announced our intent to submit an NDA later this year for single- agent use of romidepsin in patients with cutaneous T-cell lymphoma. These combination data support the continued expansion of our clinical development program to fully understand the potential of this important drug."

The results from the GPI-06-0003 trial were given in a presentation entitled Phase I Study of Romidepsin in Combination with Gemcitabine in Patients with Pancreatic and Other Advanced Solid Tumors on June 1, 2008 at the ASCO Annual Meeting.

About the Romidepsin Phase 1 Combination Trial with Gemcitabine in Solid Tumors

GPI-06-0003 is a Phase 1 dose escalation trial of the combination of romidepsin and gemcitabine designed to determine the maximum tolerated dose of the combination at 2 dosing schedules, determine the toxicities of the combination at each dose schedule and evaluate preliminary anti-tumor activity of the combination. Study patients received romidepsin as a 4-hour IV infusion followed by gemcitabine infusion over 30 minutes on days 1, 8 and 15 or days 1 and 15 every 28 days. Thirty-six patients have been enrolled with most patients presenting with Stage IV disease at the time of enrollment. Safety data from 32 patients and duration of treatment and best response data from 33 patients were evaluated for response at the time of this analysis. The combination of romidepsin and gemcitabine was generally well tolerated with the most common adverse events being gastrointestinal disturbances, fatigue, bone marrow suppression and anorexia. Of the 33 patients analyzed for response, 1 patient with ovarian cancer experienced a minor response (29% decrease in tumor mass) and there were 15 patients with stable disease, 15 patients with progressive disease and 2 patients were not evaluable. Of note, 5 patients with pancreatic cancer and 5 patients with breast cancer had stable disease for greater than or equal to 4 months.

About Romidepsin

Romidepsin is a late-stage oncology drug candidate that is active across a broad range of hematological malignancies. A registration trial in cutaneous T-cell lymphoma (CTCL) has recently been completed, successfully meeting its primary endpoint based on overall response rate. A registration trial in a second indication, peripheral T-cell lymphoma (PTCL), is currently enrolling patients. Complete and durable responses were observed in a previous National Cancer Institute trial in PTCL. Numerous other trials are ongoing in additional indications including multiple myeloma. Over 600 patients to date have received romidepsin in clinical trials with the most common adverse effects including fatigue, gastrointestinal disturbances and generally mild to moderate bone marrow suppression. The cyclic peptide structure of romidepsin is unique among members of a new class of cancer drugs known as histone deacetylase, or HDAC, inhibitors. HDAC inhibition has been shown to increase acetylation of histones and other proteins, which is associated with anti-tumor activity including chromatin remodeling, tumor suppressor gene transcription, growth inhibition, and apoptosis. Preclinical studies suggest that romidepsin is a pan-HDAC inhibitor that is among the most potent inhibitors of both Class I and Class II HDACs. Gloucester Pharmaceuticals retains worldwide rights to romidepsin which received Orphan Drug Designation from the FDA for the treatment of non-Hodgkin T-cell lymphomas, including CTCL and PTCL, and Orphan status from the EMEA for the treatment of both CTCL and PTCL. The FDA has also granted Fast Track status for CTCL and PTCL. An NDA submission for romidepsin in CTCL is anticipated in 2008 and an MAA submission is projected for 2009.

About Gloucester Pharmaceuticals

Gloucester Pharmaceuticals acquires clinical-stage oncology drug candidates and advances them through regulatory approval and commercialization. The Company's first candidate, romidepsin, a novel HDAC inhibitor, is in late-stage development for T-cell lymphomas and has shown activity across a broad range of hematological malignancies. Gloucester has completed a registration trial of romidepsin in patients with CTCL and expects to submit applications for marketing approval in the US in 2008 and the EU in 2009. The Company is also enrolling patients in a registration trial for PTCL and is evaluating romidepsin in multiple additional indications including multiple myeloma. For more information, please visit www.gloucesterpharma.com.

Source: Business Wire

More News in this Category