LONDON - Scotia Holdings plc released positive results in the pivotal Phase III trial of Foscan, its photodynamic therapy for the treatment of head and neck cancers. This paves the way to complete an NDA submission to the FDA by the end of September.
Foscan was granted fast-track status in March, and the company, based in Stirling, Scotland, said that pending approval it will launch the product by the second quarter of 2000.
CEO Rob Dow told BioWorld International, "We are very pleased because we always believed that Foscan would have great palliative benefits, and we have now demonstrated that this is so. In addition this is good news for our investors - to hear that sales are on the way, and there is an end in prospect to the cash burn."
This submission will not be Scotia's first. It previously applied, unsuccessfully, for approval in Europe of Tarabetic for the treatment of complications of Type II diabetes. Dow said it was of "enormous significance" to be on the way to getting approval of Scotia's first filing in the U.S.
"Those [filings] in Europe failed through inadequate data, so it will have a big impact on the standing of the company and on the staff to know that we have the competence and skills to put together a successful application," he said.
The full data are to be presented at a forthcoming meeting but in summary they show 60 percent of patients treated with Foscan derived clinical palliative benefit, 15 percent achieved meaningful reduction of tumor, and 11 percent had complete tumor response.
Foscan was partnered with Boehringer Ingelheim, but the US$39 million deal was terminated in December 1998. Dow said discussions with potential partners are ongoing and he expected to agree to a deal by the time the FDA grants approval.
Scotia also is planning to expand the indications for Foscan, and will soon start new clinical trials in undisclosed cancers.