21 March 2013 | News | By BioSpectrum Bureau
Patient treatment in the study commenced in January 2012
Singapore: Patient recruitment in phase II CALM trial has accelerated significantly in the past three months with 25 patients now enrolled. Viralytics, which is conducting the trial, said current patient recruitment is active across eight US clinical trial sites, with all patients receiving intratumoural injections of Cavatak.
This current patient recruitment rate compares with 13 enrolled patients announced in October 2012 of a target total recruitment of approximately 63 patients.
Patient treatment in the CALM (Cavatak in late-stage melanoma) study commenced in January 2012, with the trial investigating the clinical efficacy and safety of Cavatak in patients with stage IIIc or stage IV melanoma. Each patient will receive a series of 10 intratumoral injection visits of Cavatak. Patients who have benefited from Cavatak over the first six months on study can enter an extension trial and receive a further nine doses to complete a 48 week study period.
"The rapid increase in recruitment is very encouraging," said Dr Malcolm McColl, chief executive officer, Viralytics. "We expect to add more clinical sites over the next few months to continue to accelerate recruitment."