Protherics PLC announces Research Update
June 24 2008 - 2:00AM
Marketwired
Cheshire, UK , 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 USUSD30 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 hypertension 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,
CoVaccine HT(TM). In addition both antibody response and effect 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�, modulated key hormones involved
in regulating blood pressure in hypertensive patients. A new
formulation of ATV has now been developed, incorporating the
CoVaccine HT(TM) adjuvant, which has demonstrated a much stronger
immune response in pre-clinical models. CoVaccine HT(TM) and ATV
are protected by extensive patents and applications in the US, EU
and the rest of the world. The first US patent on ATV was granted
in May 2008. Andrew Heath, Chief 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." *Company
estimates / Ends / For further information please contact:
Protherics 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 +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. Protherics has produced two FDA approved
biologics for critical care use which are currently sold in the US:
CroFabTM, a North American pit viper antivenom and DigiFabTM, a
digoxin antidote. Protherics reported revenues of GBP26.1 million
for its year ended 31 March 2008 and a strong cash balance of
GBP37.7 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(TM)
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 manufacturing 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 containing 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(TM), which has shown evidence
of stimulating a much stronger immune response in pre-clinical
models. CoVaccine HT(TM) 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 sustained 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 About
Hypertension Hypertension is one of the most common medical
conditions in developed countries and is a risk factor associated
with heart attacks, heart failure, blood vessel 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 USUSD30 billion per annum. 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
Contacts: RNS Customer Services 0044-207797-4400 Email Contact
http://www.rns.com
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