Protherics PLC
Protherics starts OncoGel(TM)phase 2b study
in oesophageal cancer
London, UK; Brentwood, TN, US; 24 January 2008 - Protherics PLC ("Protherics" or
the "Company"), the international biopharmaceutical company focused on critical
care and cancer, today announces that the first patient has now been enrolled in
a phase 2b study of OncoGel(TM)in oesophageal cancer. OncoGel(TM)is a novel
locally-administered sustained-release formulation of paclitaxel, an established
chemotherapeutic agent for the treatment of solid tumours.
OncoGel(TM)is designed to improve locoregional control of solid tumours. Data
from a phase 2a study in inoperable oesophageal cancer, where OncoGel(TM)was
administered in conjunction with external radiation therapy, showed that 80% of
patients had an improvement in their dysphagia score (a measure of difficulty in
swallowing), and 70% had a reduction in tumour volume with an average reduction
of 47% in the responding patients. Biopsies were also found to be negative for
cancer cells in four patients and one additional patient was able to have a
successful surgical resection.
The multinational randomized phase 2b study will evaluate
OncoGel(TM)administered in combination with pre-operative chemoradiotherapy
versus pre-operative chemoradiotherapy alone in 124 patients. The primary
endpoint of the study is a blinded assessment of tumour response; overall
survival is one of the secondary endpoints. Protherics expects to have
preliminary data available from the phase 2b study in the first half of 2010.
Andrew Heath, Chief Executive of Protherics commented:
"Following the encouraging phase 2a study, we are hopeful that the phase 2b
study will provide further data to support the use of OncoGel as a potential
treatment to increase the life expectancy for people with oesophageal cancer, a
particularly devastating cancer."
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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, Jonathan Birt +1 212 850 5600
Or visit www.protherics.com
Notes for Editors:
About OncoGelTM
OncoGel(TM)is a novel locally-administered, sustained-release formulation of
paclitaxel, an established chemotherapeutic for the treatment of solid tumours.
OncoGel(TM)is designed to release paclitaxel into the tumour or tumour resection
cavity continuously, over four to six weeks, to achieve a far greater and
sustained concentration of paclitaxel at the tumour site compared to that
achieved when paclitaxel is administered intravenously at the maximum tolerated
dose. Additionally, only low levels of paclitaxel are observed in the blood,
minimising systemic side effects. For more information, visit
http://www.protherics.com/products/cancer.asp
About Oesophageal Cancer
The American Cancer Society has estimated that around 15,000 new cases of
oesophageal cancer are reported in the US each year with more than 13,000 deaths
per annum. Approximately half of newly diagnosed patients present with local or
loco-regional disease and are eligible for pre-operative chemoradiotherapy.
Pre-operative therapy using a combination of cisplatin and 5-FU with external
beam radiotherapy has been shown to provide a modest survival benefit and is the
standard therapy for curative intent in patients with inoperable oesophageal
cancer in the US.
About Protherics
Protherics (LSE: PTI, NASDAQ: PTIL) is a leading biopharmaceutical company
focused on the development, manufacture and marketing of specialised products
for critical care and cancer.
Protherics has developed and manufactures two biologics for critical care which
are FDA approved and currently sold in the US: CroFab((TM)), a pit viper
antivenom and DigiFab(TM), a digoxin antidote. Protherics generated £31.1
million in revenues in its financial year ended 31 March 2007, and reported
£46.9 million in cash at the half year ending 30 September 2007. The Company's
strategy is to use the revenues generated from its marketed and out-licensed
products to help fund the advancement of its broad, late stage pipeline.
Protherics expects to have six programmes in phase 2 development in 2008.
Protherics has two major development opportunities in its critical care
portfolio. AstraZeneca is currently undertaking a phase 2 programme with
CytoFab((TM))for the treatment of severe sepsis, following a major £195 million
licensing deal with Protherics in December 2005. In addition, Protherics is
on-track to report in the first half of 2008 the results of a phase 2b study
with a Digoxin Immune Fab for the treatment of pre-eclampsia.
Protherics has a pipeline of four novel cancer products in clinical development,
and intends to undertake the sales and marketing of these products in the US and
or the EU. Protherics is preparing to resubmit a BLA for Voraxaze(TM), an
adjunct to high dose methotrexate therapy, under a rolling submission in the US
starting in H2 2008.
With headquarters in London, the Company has approximately 290 employees across
its operations in the UK, US and Australia. For further information visit:
www.protherics.com
Disclaimer
This document contains forward-looking statements that involve risks and
uncertainties, including with respect to Protherics' product pipeline and
anticipated development and clinical trials for product candidates. 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, including the 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
Protherics PLC announces - Research Update
| Source: Protherics PLC
Cheshire, UK--(Marketwire - January 24, 2008) -