Cheshire, UK--(Marketwire - November 20, 2007) -
Protherics PLC
Patient recruitment in phase 2b "DEEP" study
in severe pre-eclampsia completed ahead of schedule
London, UK; Brentwood, TN, US; 20 November 2007 - Protherics PLC ("Protherics"
or the "Company"), the international biopharmaceutical company focused on
critical care and cancer, today announces that the last patient in the phase 2b
Digibind® Efficacy Evaluation in Pre-eclampsia (DEEP) study in severe
pre-eclampsia, a potentially life-threatening condition of pregnancy, has been
enrolled and treated.
The DEEP study is a placebo-controlled investigation of the efficacy and safety
of GlaxoSmithKline's Digibind® in 50 patients with severe pre-eclampsia. The
study enrolled women experiencing severe pre-eclampsia in the 24th - 34th week
of pregnancy, and for whom the delivery of the baby was considered necessary
within 72 hours to prevent possible life-threatening complications for the
mother and baby. Primary endpoints are the use of antihypertensive medication
and creatinine clearance which is a clinically important measure of renal
function. Secondary endpoints include the time to delivery of the baby. The
study is on track to report in the first half of 2008.
Following the licensing deal with Glenveigh Pharmaceuticals announced in
December 2006, Protherics has the rights to use Digoxin Immune Fabs (DigiFab™
and Digibind®) as potential treatments for pre-eclampsia. If the data from
the DEEP study are positive, the Company will decide whether to continue
development in this indication with Digibind® or its own product, DigiFab™.
Andrew Heath, Chief Executive of Protherics commented:
"We are delighted that the last patient has been enrolled ahead of schedule and
we look forward to seeing the results in the first half of 2008. If the data
are positive, we will talk to the regulators to determine the next steps in
bringing this potential new treatment for severe pre-eclampsia to the market to
improve prospects for both mother and baby."
| Ends |
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, Lara Mott +44 (0) 20 7831 3113
New York: John Capodanno, Jonathan Birt +1 212 850 5600
Or visit
www.protherics.com
Notes for Editors:
About Pre-eclampsia
Pre-eclampsia is a life-threatening disorder occuring in 5-8% of pregnancies in
the US 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 total US market for
pre-eclampsia is worth up to $5 billion with the severe pre-eclampsia market
worth approximately $900 million in the US alone.
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
DigiFab™, which have been found to bind to EDLFs in vitro, may have potential
application in the treatment of pre-eclampsia.
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. 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. CytoFab™ is being developed by AstraZeneca, for the treatment of
severe sepsis, after a major GBP195 million licensing deal with AstraZeneca in
December 2005. An additional, expanded phase 2 programme is due to start
shortly. In addition, Protherics is currently undertaking a phase 2b study with
Digoxin Immune Fab for the treatment of pre-eclampsia. This study is expected to
report in the first half of 2008.
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 H1 2008.
Protherics has a strong cash position, with cash balances at 30 September 2007
of GBP46.9 million, having completed a GBP38 million equity fundraising in January
2007 and received a GBP10 million milestone payment from AstraZeneca in April
2007.
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.
This information is provided by RNS
The company news service from the London Stock Exchange