Protherics PLC
DEEP results in pre-eclampsia to be presented at leading conference
London, UK; Brentwood, TN, US; 6 August 2008 - Protherics PLC
("Protherics" or the "Company"), the international biopharmaceutical
company focused on critical care and cancer, today announces that data
from the "DEEP" study has been selected as one of the
key presentations at the 16th World Congress of The International
Society for the Study of Hypertension in Pregnancy (ISSHP) in
Washington DC, US 21-25 September 2008.
On 22 April Protherics announced that its placebo-controlled phase
2b Digibind® Efficacy Evaluation in Pre-eclampsia ("DEEP") study in
severe pre-eclampsia met one of its two primary endpoints. An abstract
of the study results prepared by Protherics and other stakeholders in
the programme has been selected by ISSHP for presentation at the
opening plenary session on 22 September 2008. In addition,
two abstracts describing research data supporting the mechanism of
action of Digoxin Immune Fabs (DIFs) in pre-eclampsia have also been
accepted for presentation. Please see the ISSHP's website for more
details: http://www.isshp2008-washington.org/
Dr Garrett K. Lam, lead clinical investigator on the DEEP
study commented, "The opportunity to present the results of the DEEP
study at the ISSHP's World Congress reflects the considerable
scientific and medical interest in this important study
in pre-eclampsia, as this is the first time a drug has shown a clinical
benefit towards improving an end organ function in pre-eclamptic
patients. This study will advance efforts to identify the underlying
cause(s) of this life-threatening condition."
Andrew Heath, CEO commented: "We are delighted that the DEEP study
results will be one of the leading presentations at this prestigious
meeting. Discussions with key stakeholders about how to progress this
important programme continue, and we are encouraged by the interest
shown in the programme to date. We expect to give a further update on
next steps towards the end of the year."
Protherics also announces today that a patent has been granted in
the US covering the use of DIFs, including Digibind® (GlaxoSmithKline)
and DigiFabTM, as a method for controlling pre-eclampsia and eclampsia.
/ Ends /
For further information please contact:
Protherics
London, UK: Nick Staples, Director of Corporate +44 (0) 7919 480510
Affairs
Brentwood, US: Saul Komisar, President Protherics +1 615 327 1027
Inc
Financial Dynamics - press enquiries
London, UK: Ben Atwell, Lara Mott +44 (0) 20 7831 3113
New York, US: John Capodanno +1 212 850 5600
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, CroFabTM and DigiFabTM,
approved for sale in the US. The Company has the opportunity to
sell these products in the US from October 2010 together
with VoraxazeTM, 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
CytoFabTM which has been partnered with 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 to help grow the Company.
Protherics reported revenues of GBP26.1 million for the year ended 31
March 2008 and a strong cash balance of GBP37.7 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 Digoxin Immune Fabs
Digibind® and DigiFabTM are intravenously administered polyclonal
antibody fragments (Fab) designed to bind and neutralise digoxin. These
products are used in the treatment of patients with life-threatening or
potentially life-threatening digoxin toxicity or overdose.
Digoxin is the most commonly used cardiac glycoside in the treatment of
congestive heart failure, and is also used to slow heart rate in some
cardiac disturbances. Digoxin toxicity can cause potentially
life-threatening heart rhythm disturbances, ranging from very slow to
rapid ventricular rhythms.
About Pre-eclampsia
Pre-eclampsia is a life-threatening disorder occurring in 10% of
pregnancies worldwide per year. It is characterised by high blood
pressure and can lead to renal failure and seizures. It typically
results in the early delivery of the baby, with potential developmental
abnormalities and the possible death of the mother and/or baby. By
conservative estimates, pre-eclampsia and other hypertensive disorders
of pregnancy are responsible for 76,000 deaths each year in the US.
Pre-eclampsia is also a major cause of admission of babies into
Neonatal Intensive Care Units (NICU). Currently there are no approved
therapies available to treat pre-eclampsia and few products in
development. The cause of pre-eclampsia has not been conclusively
identified but several vasoactive substances called endogenous
digoxin-like factors (EDLFs) have been identified in the blood and
placenta of women with pre-eclampsia. These EDLFs rapidly disappear
following delivery of the baby, coincident with the disappearance of
the symptoms of pre-eclampsia. Both Digibind® and DigiFabTM
(Protherics), which have been found to bind to EDLFs in vitro, may have
potential application in the treatment of pre-eclampsia.
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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
Contact Information: Contacts: RNS Customer Services 0044-207797-4400 http://www.rns.com