Start of
phase 2a
clinical
study of Angiotensin Therapeutic Vaccine in
hypertension
London, UK; Brentwood, TN, US;
2
4
June
2008
-
Protherics
PLC ("Protherics" or the "Company"), the international biopharmaceutical company focused on
critical care and
cancer,
today
announces
that the first patient has
been enrolled in a phase 2a study
of
its
Angiotensin Therapeutic
Vaccine (ATV) for the treatment of hypertension.
Hypertension is a major risk factor for serious and common
cardiovascular diseases such as heart attacks and strokes and the global market
for anti-hypertensive therapies is estimated to be worth around US$30
billion*.
The majority of existing therapies
are
tablets
which
need to be taken
on a
daily
basis
, usually for the rest of a patient's life.
However, many patients with high blood pressure fail to
take their medicines as prescribed, and it is estimated that
approximately
70%
of
patients with hypertension do not have their blood pressure
adequately controlled*.
Therefore, a
vaccine approach, which may require
only
three injections and a booster after six months rather than
daily medication,
should
improve
patient compliance with treatment.
The phase 2a
,
double-blind
, placebo-
controlled
clinical
study
in 124
patients with
mild to moderate hypertensi
on
has been initiated
in the
UK
.
Patients will be
given
a course of
injections
over
six
weeks
.
The study will assess the safety and tolerability of the
vaccine
,
incorporating
Protherics
'
promising
novel vaccine adjuvant, Co
V
accine HT™.
In addition
both antibody response and effe
ct on blood
pressure will be assessed
.
The blood pressure results are expected in the first half
of 2009.
Protherics has shown
in
a
previous
phase 2a study that a
formulation of ATV
,
incorporating the vaccine adjuvant Alhydrogel
®
,
modulate
d
key hormones involved in regulating blood
pressure
in hypertensive patients
.
A new
formulation of ATV has now been developed,
incorporating
the
CoVaccine HT™
adjuvant
, which has
demonstrated
a much stronger immune response in pre-clinical
models.
CoVaccine HT
™
and ATV are protected by extensive patents and
applications in the
US
,
EU and
the
rest of the
w
orld.
The first
US
patent on ATV was granted in May 2008
.
Andrew Heath, C
hief Executive of Protherics,
commented
:
"
We are excited about the prospects for ATV
, a potential
value driver for the company
.
A vaccine approach to the treatment of high blood pressure
promises to
address
the issue
of
poor patient compliance with daily
medication
and
thus
reduce the incidence of stroke and heart attacks.
With data expected within a year, this could be a major
outlicensing opportunity.
"
For further information please contact:
|
|
|
Nick Staples,
Director of Corporate Affairs
|
|
Saul Komisar
, President
,
Protherics Inc
|
|
|
|
|
Financial Dynamics
- press enquiries
|
|
London:
Ben Atwell
, Lara Mott
|
|
New York
: John Capodanno
|
|
Or visit
www.protherics.com
Protherics (LSE: PTI, NASDAQ: PTIL) is a
leading
international
biopharmaceutical company focused on specialist products
for critical care and cancer.
Protherics has produced two FDA approved biologics for
critical care use which are currently sold in the
US
: CroFab™, a
North American
pit viper antivenom and DigiFab™, a digoxin antidote.
Protherics reported revenues of £2
6.1
million for its year end
ed
31 March 2008 and
a
strong cash balance of £37.7 million.
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
portfolio. CytoFab™ is being developed by AstraZeneca, for the treatment
of severe sepsis, following a major licensing deal announced in December 2005.
AstraZeneca is conducting an additional phase 2 programme following changes to
the commercial manufacturin
g process. A new formulation of Angiotensin Therapeutic
Vaccine, for the treatment of hypertension,
has today commenced a
phase 2a study.
Protherics also has four novel products being
developed in a range of
cancer indications
where
it intends to undertake the sales and marketing in
the
US
and/or the EU.
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 Angiotensin Therapeutic Vaccine
Angiotensin Therapeutic Vaccine
(ATV) is a conjugate vaccine
con
taining
a peptide analogue of the
hormone angiotensin I cross linked to the carrier protein keyhole limpet
haemocyanin (KLH).
ATV is designed to treat
hypertension by stimulating the immune system to neutralise angiotensin I, a
peptide hormone that plays a key role in the regulation of blood
pressure.
Protherics has previously shown in
hypertensive patients that
a first generation formulation
of
ATV
modulates key hormones involved in
regulating blood pressure.
An improved formulation of
ATV
has now been
developed
, incorporating a novel vaccine
adjuvant,
CoVaccine HT™
,
which has shown evidence of
stimulating a much stronger immune response in
pre-clinical
models
.
CoVaccine HT™
was acquired by in June 2006
by Protherics from
CoVaccine BV
.
A vaccine approach to the
management of hypertension is expected to improve patient compliance with
therapy, which is a major problem in achieving control of high blood pressure
with current therapy.
Because of its envisaged slow
onset and susta
ined effect, ATV
has the potential to be used
on its own, or in combination with existing high blood pressure medications, to
improve the control of hypertension.
For more information, visit
http://www.protherics.com/Products/other_products.aspx
Hypertension is one of the most
common medical conditions in developed countries and is a risk factor
associated with heart attacks, heart failure, blood ves
sel problems and kidney
damage.
Current treatments are tablet
based, requiring daily doses, often for life, and patient compliance
is
often poor.
The pharmaceutical market for high
blood pressure treatment is the largest single therapeutic sector in the world,
with global sales exceeding US$30 billion per annum.
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.