Protherics PLC
Additional "DEEP" study analyses and new mechanistic data presented at
major conference
London, UK; Brentwood, TN, US; 24 September 2008 - Protherics PLC
("Protherics" or the "Company") the international biopharmaceutical
company focused on critical care and
cancer, today reports the findings of further analyses of data from its
placebo-controlled phase 2b Digibind® (GSK) Efficacy Evaluation in
Pre-eclampsia ("DEEP") study. These new analyses, together with results
from a mechanistic study, were presented in two oral presentations at
the 16th World Congress of The International Society for the Study of
Hypertension in Pregnancy (ISSHP) in Washington DC, US this week.
The first presentation, an oral plenary
presentation entitled 'Antepartum Administration of a Digoxin Immune
Fab (DIF, Digibind®) Improves Renal Function in Patients with Severe
Pre-eclampsia' was presented by Dr Garrett K. Lam, a
spokesperson for the investigators involved in the DEEP
study. This reiterated findings reported by Protherics in
April that DIF preserved maternal renal function, the first time a drug
had shown a clinically significant benefit in the function of a target
organ in patients with severe pre-eclampsia, and exhibited a favorable
safety profile. Importantly, this presentation reported findings
from new analyses which indicate that very low birth weight babies
(1250 g or less) born to mothers in the DIF group had a more favourable
outcome than expected and a better outcome than low birth weight babies
born to mothers in the placebo group. The differences between groups
for the most serious conditions of prematurity, severe (Grade 3 and 4)
intraventricular hemorrhage (IVH) and necrotizing enterocolitis (NEC),
were marked, with no babies (0/18) in the DIF group with severe IVH
versus 21% (3/14) in the placebo group (P=0.07) and only 6% (1/18)
of babies in the DIF group having NEC versus 21% (3/14) in the placebo
group (P=0.30).
A second oral presentation, a mechanistic study undertaken using
samples from the DEEP Study, entitled 'In-Vivo Reversal of Functional
Sodium Pump Inhibition with Digibind® Treatment' was presented at the
conference by Dr. Steven W. Graves of Brigham Young University,
Utah, US, a leader in research into the role of the sodium pump and its
inhibitors in disease. There was significantly (P=0.03) less inhibition
of the sodium pump in sera from women in the DIF group following
treatment than in the placebo group (similar levels of inhibition were
seen in both groups prior to treatment). This finding supports the
theory that DIF binds to and thus removes endogenous digoxin-like
factors (EDLFs), which are known to inhibit the sodium pump and are at
higher levels in women with pre-eclampsia from the circulation. The
reduced inhibition of the sodium pump could explain the preservation of
renal function seen in women in the DIF group in the DEEP study.
Severe pre-eclampsia is a potentially life threatening complication of
pregnancy for which there is no effective treatment other than delivery
of the baby and pre-eclampsia is a leading cause of maternal and infant
death throughout the world. Protherics and other stakeholders in the
programme intend to discuss the data from the study and the potential
next steps in the clinical development of DIF for severe pre-eclampsia
with FDA in early 2009.
Andrew Heath, Chief Executive of Protherics, commented:"We are excited by
these promising new analyses of the DEEP study
results which suggest that a larger study to further explore the
clinical benefits of Digoxin Immune Fabs on neonatal
outcomes in severe pre-eclampsia may be warranted. We look forward to
discussing next steps with key stakeholders to determine the future
direction for this important programme in pre-eclampsia. There is an
urgent need for new products to treat pre-eclampsia as there are
currently no approved therapies available and few products
in development."
/ Ends /
For further information please contact:
Protherics
Ashley Tapp, Communication Manager +44 (0) 7790 811 554
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 +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 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 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.
On Thursday, 18th September Protherics announced a proposed merger with
BTG through a recommended share offer.
For further information visit www.protherics.com
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.
About Digoxin Immune Fabs
Digibind® and DigiFabTM are intravenously administered polyclonal
antibody fragments (Fab) designed to bind and neutralize 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.
*Digibind® is a trademark of the GlaxoSmithKline group of companies
Intraventricular Hemorrhage (IVH)
An intraventricular hemorrhage (or "IVH") is a bleeding of the brain's
ventricular system, where the cerebrospinal fluid is produced and
circulates through towards the subarachnoid space. It can result from
physical trauma or from hemorrhaging in stroke. This type of hemorrhage
is particularly common in infants, especially premature infants
or those of very low birth weight.
Necrotizing Enterocolitis (NEC)
Necrotizing enterocolitis is a gastrointestinal disease that mostly
affects premature infants. It involves infection and inflammation that
causes destruction of the bowel (intestine) or part of the bowel.
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
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