LONDON - The first presentation of results from the pivotal trials of Scotia Pharmaceuticals Ltd.'s photodynamic therapy agent Foscan showed total tumor elimination in 16 percent of 64 patients with inoperable head and neck cancers. A further 9 percent had partial reductions of their tumor, while 58 percent of patients achieved meaningful palliative effect.
The chief investigator, Barry Wenig, said the results were very significant and exciting. "We had not set out specifically to achieve tumor response, which appears to be very impressive. It is important to remember that we are dealing with patients who were considered incurable. In the light of this the results are remarkable."
Wenig presented the results at the American Society of Clinical Oncology (ASCO) meeting in New Orleans.
The study was looking at the palliative effects of Foscan mediated photodynamic therapy in patients who were classed as incurable as the other forms of standard treatment (surgery, radiotherapy, chemotherapy) had been exhausted. The study also measured survival time and the tolerability and safety of Foscan. The mean survival time was 110 days, and follow-up is ongoing.
Wenig said Foscan also has significant clinical benefits in that the treatment is not associated with a deterioration in quality of life, nor with impaired function. The cosmetic results are excellent and treatment can be repeated.
Scotia, based in Stirling, Scotland, submitted Foscan for registration in the U.S. and Europe in September 1999, and currently is negotiating with marketing partners. CEO Robert Dow said the presentation at ASCO was an important step because this was the first time that oncologists have had the chance to review Phase III data on Foscan.