Wednesday, 3 September 2008

Start Of Prolarix� Phase 2 Study In Liver Cancer

� Protherics PLC ("Protherics" or the "Company"), the international biopharmaceutical company focused on decisive care and cancer, announces the knowledgeableness of a phase 2a proof-of-concept study of Prolarix�, a targeted prodrug chemotherapy being highly-developed for the treatment 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 vulgar cause of cancer in the world1 and despite the recent approval of sorafenib (Nexavar�, Onyx/Bayer), a new chemotherapy which is being adoptive 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 eld.


The phase 2a proof-of-concept study is designed to evaluate neoplasm response in addition to safety and tolerability of Prolarix in 14 patients with non-resectable HCC world Health Organization have not been treated with sorafenib. The report has been initiated at a situation in Belgium and extra study sites in East Asia have been identified for inclusion in the study. The results of the sketch 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 treatment 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 malignant neoplastic disease statistics, 2002 CA Cancer J Clin. 2005;55;74-108


About Protherics


Protherics (LSE: PTI, NASDAQ: PTIL) is a leading external biopharmaceutical company focused on specialist products for critical care and cancer.



The Company has deuce critical concern products, CroFab� and DigiFab�, approved for sale in the US. The Company has the opportunity to sell these products in the US from October 2010 together with Voraxaze�, a supportive cancer care product, next anticipated commendation in the US in 2010. Protherics is besides developing a number of other products in the cancer arena that it can market in-house.


In addition, Protherics has various potential smash hit products that require development and commercialization partners. These include CytoFab� which has been partnered by AstraZeneca in a major licensing deal, and also Angiotensin Therapeutic Vaccine and Digoxin Immune Fabs for which licensing partners will be sought in 2008-2009. These products receive the voltage to be high value products that can provide additional financing for the Company.


Protherics reported revenues of �26.1 jillion for the year over 31 March 2008 and a stiff cash balance of �37.7 zillion. With headquarters in London, the Company has approximately 300 employees across its operations in the UK, US and Australia.

About Prolarix�


Prolarix is a targeted chemotherapy existence developed for the handling of chief liver cancer the Crab (hepatocellular carcinomas, HCC) and other choice tumours. Prolarix is a combination therapy of two low molecular weight compounds, a prodrug* (called tretazicar; previously CB1954) and an enzyme co-substrate* (called caricotamide; previously EP-0152R). The prodrug tretazicar toilet be activated by an endogenous enzyme called NQO2, to a highly responsive, short-lived cytotoxic agent which causes a high degree of DNA cross-linking. The NQO2 enzyme is latent and hence inactive in body tissue, but Protherics' scientists get discovered that the enzyme is active in the presence of a co-substrate called caricotamide. The NQO2 enzyme is absent or in low levels in many normal body tissues, including bone marrow, but its natural action is increased in sealed tumour types (particularly hepatocellular carcinomas). The coadministration of the prodrug tretazicar and the cosubstrate caricotamide is therefore expected to event in the enhanced activation of the prodrug in the quarry tumour cells, resulting in their death whilst minimising harm to healthy, non-cancerous cells.

Glossary


Prodrug* - A compound that is converted within the body into its fighting form and that has no therapeutical effects of its possess. A prodrug is useful when the active drug may be too toxic to administrate systemically, the active dose is captive poorly by the digestive tract, or the organic structure breaks down the active drug ahead it reaches its mark.


Co-substrate* - A speck that interacts with an enzyme and is compulsory for its activity.


Cytotoxic* - A chemical which has a direct toxic effect to cells, causation their expiry.


Tretazicar* is 5-(aziridin-1-yl)-2,4-dinitrobenzamide (CB1954), an antitumour prodrug

Caricotamide* is