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
27 August 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: 27 August 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
Start of Prolarix™ 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 Prolarix™, 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
world(
1)
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
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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
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+1 212 850 5600
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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, CroFab™ and
DigiFab™, approved for sale in the US. The Company has the
opportunity to sell these products in
the US from October 2010 together with Voraxaze™,
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
CytoFab™ 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 £26.1 million for the year
ended 31 March 2008 and a strong cash balance of £37.7
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 Prolarix™
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.
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