Protherics Plc - Report of Foreign Issuer (6-K)
January 25 2008 - 8:25AM
Edgar (US Regulatory)
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C.
20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16
of
the Securities Exchange Act of 1934
24 January 2008
PROTHERICS PLC
(Translation of Registrant’s Name Into
English)
The Heath Business & Technical Park
Runcorn, Cheshire, W47 4QF England
(Address of Principal Executive Offices)
Indicate by check mark whether the registrant files
or will file annual reports under cover of Form 20-F or Form 40-F.
Form
20-F
X
Form
40-F
Indicate by check mark if the registrant is
submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Indicate by check mark if the registrant is
submitting the Form 6-K in paper as permitted by Regulation S-T Rule 191(b)(7):
Indicate by check mark whether the registrant by
furnishing the information contained in this form is also thereby furnishing the
information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act
of 1934.
Yes
No
X
If “Yes” is marked, indicate below the
file number assigned to the registrant in connection with Rule 12g3-2(b):
82-
.
The Registrant is furnishing a copy of its
announcements as reported to the Company Announcements Office of the London Stock
Exchange.
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
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PROTHERICS PLC
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Date: 24 January 2008
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By:
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/s/ Rolf Soderstrom
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Rolf Soderstrom
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Finance Director
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Protherics
PLC
Protherics starts
OncoGel™ 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™ in oesophageal
cancer. OncoGel™ is a novel locally-administered sustained-release formulation of
paclitaxel, an established chemotherapeutic agent for the treatment of solid tumours.
OncoGel™ is designed to improve locoregional control of solid tumours. Data from a
phase 2a study in inoperable oesophageal cancer, where OncoGel™ 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™ 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
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Andrew Heath, CEO
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+44 (0) 20 7246 9950
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Nick Staples,
Director of Corporate
Affairs
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+44 (0) 7919 480510
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Saul Komisar, President Protherics Inc
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+1 615 327 1027
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Financial Dynamics
– press
enquiries
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London: Ben Atwell, Lara Mott
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+44 (0) 20 7831 3113
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New York: John Capodanno, Jonathan Birt
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+1 212 850 5600
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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 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™, a pit viper antivenom and DigiFab™, 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™ 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™, 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.
END
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