Kahalalide F, the novel anti-tumour agent derived from the sea slug Elysia rufescens, has entered Phase II clinical studies for liver carcinoma. PharmaMar announced that the decision to progress Kahalalide F to Phase II in this indication was made following promising results reported at the end of Phase I studies in patients with advanced solid tumours.

The trial will involve five different specialist cancer centres and will investigate the efficacy of Kahalalide F in patients with advanced liver carcinoma using a starting dose of 650 microg/m2 administered as weekly 1-hour intravenous infusions. This dosing regimen has been chosen following careful review of results from Phase I trials of Kahalalide F in advanced solid tumours, which were reported last year. During these Phase I trials, in patients with late-stage disease that had not responded to any previous treatment, a clinical benefit for Kahalalide F had been noted in liver carcinoma, prompting Phase II studies.

"Kahalalide F has shown an encouraging benefit/risk profile in our initial clinical studies, and we are optimistic that it will perform well in this specific study in liver carcinoma", stated Dr M. Izquierdo, Director of Clinical Oncology at PharmaMar.

Liver carcinoma is one of the most common cancers worldwide (2 to 5 cases per 100,000 people in Europe and the US) with rising incidence rate due to the spread of hepatitis C infections. Because of the aggressiveness of the disease therapeutic options are limited and surgery is the main treatment presently available, but it is not suitable for patients with metastatic disease. Liver carcinoma has shown considerable resistance to conventional chemotherapies, and the development of new agents is one of the most important priorities for the treatment of this cancer.