Author: press release
Oncolytics Biotech Inc. announced that interim clinical results from its Phase I/II U.K. trial of Reolysin(R) combined with paclitaxel/carboplatin for patients with advanced cancers were presented at the Fifth International Meeting on Replicating Oncolytic Virus Therapeutics. The meeting is being held in Banff, Alberta from March 18th to 22nd, 2009. The principal investigator for the trial is Dr. Kevin Harrington of The Institute of Cancer Research.
To date, fifteen head and neck cancer patients have been treated in the Phase I/II trial. All but one patient had prior platinum treatment. Of 12 patients evaluable for clinical response, five have experienced Partial Response (PR) and four have experienced Stable Disease (SD) ranging from two to six months. For patients who have been followed for at least six months since their initial treatment, the median progression-free survival (PFS) is currently six months, while the overall survival is currently seven months. The literature suggests that platinum refractory patients typically have a PFS of approximately two months and a median survival ranging from 4.5 to 6.5 months. The overall survival figure may evolve as many of the patients are still alive.
“In patients previously treated with platinum agents, where the response rate (PR and Complete Response (CR)) is generally in the 3-10% range, a response rate of 42% and a 75% clinical benefit rate (SD, PR, and CR) are dramatic,” said Dr. Karl Mettinger, Chief Medical Officer for Oncolytics.
The Phase I/II trial has two components. The first is a Phase I, open-label, dose-escalating, non-randomized study of Reolysin(R) given intravenously in combination with paclitaxel and carboplatin every three weeks. In this portion of the trial, standard dosages of paclitaxel and carboplatin are delivered to patients with escalating intravenous dosages of Reolysin(R). Eligible patients include those who have been diagnosed with advanced or metastatic solid tumours such as head and neck, melanoma, lung and ovarian that are refractory (have not responded) to standard therapy or for which no curative standard therapy exists. The second component of the trial is a Phase II, 14-patient, single arm, open-label, dose-targeted, non-randomized trial of Reolysin(R) given intravenously in combination with a standard dosage of paclitaxel and carboplatin. Eligible patients include those with advanced or metastatic head and neck cancers that are refractory to standard therapy or for which no curative standard therapy exists.
An independent, confirmatory Phase II trial using the same combination of Reolysin(R) and carboplatin/paclitaxel for patients with head and neck cancers is currently underway in the U.S. Interim results from both the U.K. and the U.S. study formed the basis of the Phase III pivotal program now being developed for Reolysin(R) in combination with carboplatin/paclitaxel in this patient population.