Cheshire, UK -- (MARKET WIRE) -- March 27, 2007 --
Protherics PLC
Protherics initiates OncoGel(TM) phase 1/2 brain cancer study
London, UK; Brentwood, TN, US; 27 March 2007 - Protherics PLC ("Protherics" or
the "Company"), the international biopharmaceutical company focused on critical
care and cancer, today announces the enrolment of the first patient in a
clinical study to investigate the use of OncoGel™, a novel formulation of
paclitaxel for local administration, as an adjuvant treatment to surgical
removal of the tumour in patients with recurrent glioblastoma multiforme (GBM).
GBM is the most common and most aggressive primary brain tumour, affecting
between 18,000-20,000 patients in the US and EU per annum. After initial
surgical resection and radiation therapy, the cancer recurs in approximately 90%
of patients, typically at the site of the original tumour. Overall prognosis is
poor for these patients, with most surviving less than one year after diagnosis.
OncoGel™ is a localised therapy designed to achieve a high concentration of
paclitaxel, a proven and widely used cytotoxic agent, at the site of the tumour
for up to six weeks. Protherics believes that GBM tumours are ideally suited to
treatment with OncoGel™ because they are known to be sensitive to paclitaxel
and typically do not metastasize to other parts of the body. OncoGel™ may
have applications in the treatment of non-resectable brain tumours, or may be
used in conjunction with surgery to destroy any tumour remaining and thus
potentially extend patient survival.
The current study will investigate the safety and tolerability of OncoGel™
administered into the cavity produced through surgical removal of the tumour.
The open-label, multi-centre, dose escalation study is being conducted at four
centres in the US and will enrol up to 36 patients who have recurrent glioma for
which surgical removal of >95% of the tumour is planned. The study will
specifically investigate any adverse changes in neurological performance or
other side effects that might be related to intracranial OncoGel™
administration at up to six different dose levels. Data from this study will
determine the dose to be used in future studies of patients with primary or
recurrent GBM. Protherics expects to have preliminary data available from the
first dose cohort in the second half of 2007, and data from all patients at the
end of 2008.
Andrew Heath, CEO commented:
"OncoGel has already produced encouraging phase 2a data in oesophageal cancer,
and we are excited about starting an additional clinical study in brain cancer,
a disease with a terrible prognosis but one which is highly applicable to
localised therapy with OncoGel."
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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, David Yates +44 (0) 20 7831 3113
New York: John Capodanno, Jonathan Birt +1 212 850 5600
Or visit www.protherics.com
Notes for Editors:
About OncoGel™
OncoGel™ is a novel locally-administered, sustained-release formulation of
paclitaxel, an established chemotherapeutic for the treatment of solid tumours.
OncoGel™ is designed to release paclitaxel into the tumour or tumour
resection cavity continuously, over four to six weeks, to achieve a far greater
concentration of paclitaxel in the tumour compared to that achieved when
administered intravenously at the maximum tolerated dose. Additionally, only low
systemic levels of paclitaxel are observed, minimising systemic side effects.
For more information, visit
http://www.protherics.com/products/cancer.aspx
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. The Company's strategy is to use the revenues
generated from its marketed products to help fund the advancement of its
development pipeline.
Protherics potentially has two major market opportunities in its critical care
franchise. CytoFab™ is being developed by AstraZeneca for the treatment of
severe sepsis, and an expanded phase 2 study is planned to start in 2007. In
addition, Protherics is currently undertaking a phase 2b study with Digoxin
Immune Fabs in the treatment of pre-eclampsia, which is expected to report in
2007.
The Company has four cancer products in development: Voraxaze™ which is an
adjunct to high dose methotrexate therapy currently in pre-registration in the
US and EU; OncoGel™, a novel formulation of paclitaxel in phase 2a
development for the management of oesophageal cancer and for the treatment of
primary brain cancer; Prolarix™, a targeted cancer therapy for the treatment
of primary liver cancer and other select tumours, which is currently in a phase
1 study; and acadesine, a novel selective therapy for the treatment of B-cell
chronic lymphocytic leukaemia, which is being prepared to enter a phase 1/2
study in mid 2007.
The Company is also developing its Angiotensin Therapeutic Vaccine for the
treatment of hypertension, where encouraging phase 2a results have already been
demonstrated and a further phase 2a study is planned with an improved
formulation in 2007.
The majority of the Company's sales revenues (£17.7m in the year ended 31 March
2006) are derived from two critical care products, CroFab™ (pit viper
antivenom) and DigiFab™ (digoxin antidote) which were developed by Protherics
and are sold, in the US, through Fougera Inc, a division of Altana AG.
Protherics' goal is to develop and attract additional critical care and cancer
products for its own sales and marketing teams to distribute in the US and
Europe.
With headquarters in London, the Company has approximately 260 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