Patients who had demonstrated resistance to the standard first-line chemotherapies of cisplatin and/or paclitaxel received phenoxodiol as an adjunct to one of the two traditional therapies. Results suggest that both groups benefited from the treatment with overall disease being controlled, prompting one Marshall executive to describe the drug as possessing “chemo-sensitizing potential”.
Dr Graham Kelly, executive chairman of Marshall, went on to further endorse the study, saying: “What gives us particular confidence to go forward into a registration trial is the level of stringency that we have used in our study.”
The multi-center trial conducted at the Yale and Melbourne, Australia only recruited patients who were either refractory or resistant to conventional treatment. Additional criteria prescribed the enrollment take place within an average seven months of completion of the last course of treatment with platinums or taxanes, when chemo-resistance remains high.
Twenty subjects received a combination of phenoxodiol and cisplatin and 20 patients received phenoxodiol and paclitaxel. 80% of subjects on combination therapy had either a complete response or partial response, or experienced disease stabilization. The overall disease control rate was 77%. The phenoxodiol and cisplatin or paclitaxel combinations were well tolerated, with no unexpected toxicities encountered.