Protherics announces start of Prolarix phase 2 study in liver cancer

Protherics PLC today announced the initiation of a phase 2a proof-of-concept study of Prolarix, a targeted prodrug chemotherapy being developed for the treaent of primary liver cancer (hepatocellular carcinoma or "HCC"). This follows promising data from a phase 1 study of Prolarix, presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, USA on 2 June 2008.

HCC is the sixth most common cause of cancer in the world¹ and despite the recent approval of sorafenib (Nexavar®, Onyx/Bayer), a new chemotherapy which is being adopted as the standard of care for HCC, life expectancy remains less than 12 months from diagnosis. Moreover, less than 20% of patients survive beyond one year, and less than 5% survive beyond five years.

The phase 2a proof-of-concept study is designed to evaluate tumour response in addition to safety and tolerability of Prolarix in 14 patients with non-resectable HCC who have not been treated with sorafenib. The study has been initiated at a site in Belgium and additional study sites in East Asia have been identified for inclusion in the study. The results of the study are expected in the second half of 2009.

Andrew Heath, Chief Executive of Protherics commented:"Scientifically acclaimed, Prolarix offers renewed hope for the many patients with primary liver cancer for whom there are very few treaent options. If the results from this study are positive, a licensing partner will be sought for Asia where the incidence of this type of cancer is highest."

1 Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002 CA Cancer J Clin. 2005;55;74-108