Cheshire, UK -- (MARKET WIRE) -- May 22, 2007 --
Protherics PLC
Protherics presents encouraging OncoGelTM phase 2a
oesophageal cancer data at leading US conference
London, UK; Brentwood, TN, US; 22 May 2007 - Protherics PLC ("Protherics" or the
"Company"), the international biopharmaceutical company focused on critical care
and cancer, announces that positive phase 2a data supporting the development of
OncoGelTM in oesophageal cancer were presented yesterday during a poster session
at the Digestive Disease Week ("DDW") 2007 Conference in Washington, DC. The
poster was selected as a "Poster of Distinction," placing it in the top 10% of
all American Gastroenterology Association (AGA) Institute abstracts selected for
poster presentation.
OncoGelTM is a novel locally-administered, sustained-release formulation of
paclitaxel, an established chemotherapeutic for the treatment of solid tumours.
The poster presented data from a phase 2a dose-escalation study evaluating the
safety, toxicity, and pharmacokinetics of OncoGelTM in eleven patients with
oesophageal cancer who were not surgical candidates but were able to receive
radiation therapy. OncoGelTM was injected into the primary tumour and adjacent
accessible lymph nodes using endoscopic ultrasound guidance, followed by
radiation therapy (50.4 Gy in 1.8 Gy fractions).
As reported at the conference, this combination OncoGelTM/radiation therapy was
well-tolerated, and no dose-limiting toxicities, OncoGelTM-related serious
adverse events or haematological events were reported for any patient.
Pharmacokinetic data indicate prolonged paclitaxel release with minimal systemic
exposure. Dysphagia symptoms improved for nine subjects, and remained unchanged
for two patients, and tumour volumes decreased for eight of the eleven patients.
The Company is planning to undertake a phase 2b study of OncoGelTM in
combination with chemoradiotherapy in oesophageal cancer patients in the second
half of 2007. Protherics recently initiated a phase 1/2 study of OncoGelTM in
primary brain cancer as an adjuvant treatment to surgical removal of the tumour
in patients with recurrent glioblastoma multiforme (GBM).
Andrew Heath, CEO of Protherics, commented:
"We are greatly encouraged by this phase 2a data, which provides proof of
concept for OncoGelTM in a cancer which causes considerable morbidity and
distress in patients with typically only a short life expectancy. We hope to
report more data from both our oesophageal cancer and primary brain cancer
programmes next year."
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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 OncoGelTM
OncoGelTM is a novel locally-administered, sustained-release formulation of
paclitaxel, an established chemotherapeutic for the treatment of solid tumours.
OncoGelTM 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.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 and the majority of patients
with oesophageal cancer present with dysphagia. As a result more than 50 per
cent of patients suffer considerable weight loss as they have difficult eating
and drinking, severely impacting their quality of life. A major goal of current
therapy is therefore to reduce dysphagia and there remains a considerable need
for a more effective therapy.
About Glioblastoma Multiforme
Glioblastoma multiforme is the most common and most aggressive primary brain
tumour. In most European and North American countries, the annual incidence is
approximately 2-3 new cases per 100,000 people per year. After an initial
surgical and radiation therapy treatment, recurrences are reported for 90% of
patients, typically at the site of the original resection. Overall prognosis is
poor for these patients, with most surviving less than one year after diagnosis.
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: CroFabTM, a pit viper antivenom
and DigiFabTM, a digoxin antidote. 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 has two major development opportunities in its critical care
portfolio. CytoFabTM is being developed by AstraZeneca, for the treatment of
severe sepsis, after a major £195 million ($340 million) licensing deal with
AstraZeneca in December 2005. An additional, expanded phase 2 programme is
planned to start in 2007. In addition, Protherics is currently undertaking a
phase 2b study with Digoxin Immune Fabs for the treatment of pre-eclampsia. This
study is expected to report in the first quarter of 2008.
Protherics has a pipeline of four novel cancer products in clinical development,
where it intends to undertake their sales and marketing in the US and EU.
Protherics is preparing to resubmit a BLA for VoraxazeTM, an adjunct to high
dose methotrexate therapy, under a rolling submission in the US starting in
early 2008.
Protherics has a strong cash position, having completed a £38.2 million (gross)
equity fundraising in December 2006 and received a £10 million milestone from
AstraZeneca.
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