GLOUCESTER BEGINS STUDY IN PATIENTS WITH MULTIPLE MYELOMA

Gloucester Pharmaceuticals announced that the first patient has been treated in a Phase I/II investigator-initiated clinical study of romidepsin in combination with bortezomib to treat patients with relapsed/refractory multiple myeloma.

The company anticipates enrolling approximately 25 patients in the dose-escalation study. Patients will receive bortezomib at a fixed standard dosing regimen and romidepsin at increasing doses in order to establish the most appropriate dose for each drug in this combination regimen. Once the appropriate dosage is determined, additional patients will be treated at that dosing regimen. The endpoints for this trial include both objective response and safety.

"Romidepsin appears to be a promising investigational drug, and preclinical data indicate that the romidepsin and bortezomib combination is synergistic. It is our hope that the combination of romidepsin and bortezomib will prove beneficial to patients and we are pleased to initiate the first clinical trial of this combination in Australia," Miles Prince, the trial's principal investigator, said.

The company now has ongoing clinical trials testing the drug in five hematologic and solid tumor indications, including pivotal registration trials in cutaneous T-cell lymphoma and peripheral T-cell lymphoma.