Protherics PLC
Start of ProlarixTM phase 2 study in liver cancer
London, UK; Brentwood, TN, US; 27 August 2008 - Protherics PLC
("Protherics" or the "Company"), the international biopharmaceutical
company focused on critical care and cancer, today
announces the initiation of a phase 2a proof-of-concept study of
ProlarixTM, a targeted prodrug chemotherapy being 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 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
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 cancer statistics,
2002 CA Cancer J Clin. 2005;55;74-108
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For further information please contact:
Protherics
Andrew Heath, CEO +44 (0) 20 7246 9950
Nick Staples, Director of Corporate Affairs +44 (0) 7919 480510
Saul Komisar, President Protherics Inc +1 615 327 1027
Financial Dynamics - press enquiries
London: Ben Atwell, Lara Mott +44 (0) 20 7831 3113
New York: John Capodanno +1 212 850 5600
Or visit www.protherics.com
Notes for Editors:
About Protherics
Protherics (LSE: PTI, NASDAQ: PTIL) is a
leading international biopharmaceutical company focused on specialist
products for critical care and cancer.
The Company has two critical care products, CroFabTM and DigiFabTM,
approved for sale in the US. The Company has the opportunity to
sell these products in the US from October 2010 together
with VoraxazeTM, a supportive cancer care product, following anticipated
approval in the US in 2010. Protherics is also developing a number of
other products in the cancer arena that it can commercialise in-house.
In addition, Protherics has several potential blockbuster products that
require development and commercialisation partners. These include
CytoFabTM 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 have the potential to be high value products
that can provide additional funding for the Company.
Protherics reported revenues of GBP26.1 million for the year ended 31
March 2008 and a strong cash balance of GBP37.7 million. With
headquarters in London, the Company has approximately 300 employees
across its operations in the UK, US and Australia.
For further information visit www.protherics.com
About ProlarixTM
Prolarix is a targeted chemotherapy being developed for the treatment
of primary liver cancer (hepatocellular carcinomas, HCC) and other
select 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 can be activated by an endogenous enzyme called
NQO2, to a highly reactive, short-lived cytotoxic agent which causes a
high degree of DNA cross-linking. The NQO2 enzyme is latent and
therefore inactive in body tissue, but Protherics' scientists have
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 activity is
increased in certain tumour types (particularly hepatocellular
carcinomas). The coadministration of the prodrug tretazicar and the
cosubstrate caricotamide is therefore expected to result in the
enhanced activation of the prodrug in the target 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 active
form and that has no therapeutic effects of its own. A prodrug is
useful when the active drug may be too toxic to administer
systemically, the active drug is absorbed poorly by the digestive
tract, or the body breaks down the active drug before it reaches its
target.
Co-substrate* - A molecule that interacts with an enzyme and is
required for its activity.
Cytotoxic* - A chemical which has a direct toxic effect to cells,
causing their death.
Tretazicar* is 5-(aziridin-1-yl)-2,4-dinitrobenzamide (CB1954), an
antitumour prodrug
Caricotamide* is 1-carbamoylmethyl-3-carbamoyl-1,4-dihydropyridine
(EP-0152R), the most stable of a series of co-substrates for
NQO2 discovered by Protherics
Disclaimer
This document contains forward-looking statements that involve risks
and uncertainties including with respect to products under development
and the progress and completion of clinical trials. Although we
believe that the expectations reflected in such forward-looking
statements are reasonable at this time, we can give no assurance that
such expectations will prove to be correct. Given these uncertainties,
readers are cautioned not to place undue reliance on such
forward-looking statements. Actual results could differ materially from
those anticipated in these forward-looking statements due to many
important factors discussed in Protherics' Annual Report on Form 20-F
and other reports filed from time to time with the U.S. Securities and
Exchange Commission. We do not undertake to update any oral or written
forward-looking statements that may be made by, or on behalf of,
Protherics.
This information is provided by RNS
The company news service from the London Stock Exchange
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