LONDON - Scotia Holdings plc said it plans to expand clinical trials of its photodynamic cancer drug Foscan into four further indications following recent submissions to the FDA and EMEA for Foscan in the treatment of head and neck cancer.

The new indications - pancreatic, prostate, skin (basal cell) and bone cancer - have been selected on the basis of preliminary Phase Ia trials. CEO Rob Dow told BioWorld International, "We expanded access to Foscan because of pressure from investigators. We supplied the drugs and they got local approvals. We therefore have data sets based on a number of patients treated according to local protocols."

The preliminary data show that in these four indications, "We can get the drug there, we can get the light there, and there is a clinical benefit." Dow said the company would be discussing with the FDA and other regulators if it needed to expand the Phase I data, or could go straight into Phase II.

Meanwhile, Scotia, based in Stirling, Scotland, is in discussions "with several significant partners" on a license deal for Foscan. Dow said he expects to seal an agreement within the next six months but the company does not need to find a partner before it starts the new trials. Foscan was previously licensed to Boehringer Ingelheim, which withdrew in November 1998. The compound has FDA fast-track status, so it could receive approval by the second quarter of 2000. In Europe approval is expected by the fourth quarter 2000.

Scotia also said it will commence trials on its second photosensitizer bacteriochlorin (SQN400) in primary and secondary liver cancer before the end of this year. The profile of SQN400 is different than Foscan. It is activated at a different and longer wavelength of light and should allow treatment of larger tumors. Dow said that whereas Foscan can be activated in tumors ranging in size from a marble to golf ball, SQN400 can be activated within a tumor mass the size of an apple.

Dow said it is not known yet how many patients will be treated in the SQN400 Phase I, nor where the trial will take place.

The company also is undertaking feasibility studies for a program to compare palliative effects of photodynamic therapy to the palliative effects of radiotherapy.

In addition, Scotia said it developed a pharmaceutical compound for the treatment of obesity based on Olibra, its food additive satiety product. Olibra, based on fractionated and purified palm and oat oils, is available in yogurts on sale in the UK, Sweden and Finland, and has been licensed to the UK dairy company St. Ivel and to General Mills Inc. in the U.S. The calorie intake from meals taken after Olibra consumption has been shown, in three separate studies, to be significantly reduced compared to placebo.

Dow said the candidate molecule SX-013, a semi-synthetic lipid, will enter Phase I in the first quarter of 2000. "We plan to get it to the end of Phase II by the end of 2001, at a cost of #5 million (US$8.3 million), and then look for a partner."

"This represents a new route to treating obesity that deals with the fundamental problem: the failure of the stomach to tell the brain it has had enough to eat."