Ark Makes Significant Advances with EG013 and EG014 Preclinical Programmes
LONDON, 19 May 2008
- Ark
Therapeutics Group plc ('Ark' or the 'Company') today provides an
update on two of its preclinical programmes, EG013 and EG014. In
November 2007, Ark raised £35.4 million net through a
Placing and Open Offer to allow
investment in a number of advanced preclinical programmes within
its gene-based medicine portfolio that had promising results and
the potential to move rapidly into the clinic.
EG013 is a Trinam® variant VEGF based
gene medicine under development for fetal growth restriction, an
often terminal condition where insufficient blood supply via the
placenta results in serious growth retardation, leading to
premature
death or undesired termination of a baby in an otherwise healthy
mother or long term neurological problems in surviving infants. The
problem is usually first diagnosed about 20 weeks into pregnancy
and at present there is no effective treatment.
Results from the first trial in a preclinical
model of blood flow to the placenta have shown that a single
treatment with EG013, given directly into the mother's uterine
artery, increased blood flow to the placenta by 25%, an improvement
that is
believed adequate to treat the condition. The latest results of the
second set of experiments have shown that the significantly
increased blood flow after treatment with EG013 is maintained out
to 50 days. If confirmed in human studies, a therapy with
this magnitude and duration of effect could allow the fetus to grow
satisfactorily to a stage where caesarean delivery of a healthy
baby could be reliably performed. Preliminary biodistribution
results using immunohistochemical techniques have indicated
that there is no transfer of the gene into the fetus.
Fetal growth restriction, in its various forms,
affects approximately 60,000 babies in the USA and Europe and is an
extremely distressing condition. The work is being undertaken as a
collaboration between Ark's scientists at University College,
London
(UCL) and the UCL Department of Obstetrics and Gynaecology.
An abstract describing the work was recently presented at an
American Society of Gynaecological Investigation where it won a
President's Investigator award.
Commenting on the results, Professor Donald
Peebles, Professor of Obstetrics and Fetal Medicine at UCL
undertaking the work, said: 'The results from this second set of
experiments are again very encouraging. The robust science behind
the gene-based
product led us to believe we would see this effect but it is always
exciting to have the theory confirmed. In common with many of the
new types of advanced biologics treatments that are coming through,
it looks as if we may be on the verge of a major
treatment breakthrough in an extremely distressing medical
condition.'
EG014 is Ark's gene derived small molecule
anti-cancer programme centred around the neuropilin 1 (NP1)
receptor. Previously reported preclinical results from Ark's early
leads have shown that blocking of the NP1 receptor has a triple
effect, killing
tumour cells, reducing blood flow to tumours and inhibiting
metastatic spread of the cancer. Work this year using advanced
crystallography and computational chemical modelling has led to the
recent discovery and understanding of the precise NP1
receptor
pocket structure and molecular binding site characteristics.
Additionally Ark has completed development of novel fast screening
assays, highly specific to the above mentioned receptor. These
developments are significant advances which now direct Ark's
chemistry to optimise the existing leads.
Commenting on this, Professor John Martin, Chief
Scientific Officer at Ark, said: 'The previous preclinical results
with NP1 indicated its potential as a broad treatment for cancer.
This precise finding had eluded us for a number of months and we
are
delighted to have made this discovery in such a precise and
detailed manner. This allows us to continue what we believe is the
last stage of our lead optimisation work in a controlled and
systematic way to give us compounds with the right potency
and
binding specificity to take into the clinic.'
Nigel Parker, CEO at Ark, added: 'In the
second half of last year we received strong support to progress a
number of preclinical programmes and we are very pleased to report
this steady and solid progress by our research groups in two of
the
projects. It is extremely exciting for us to see this breakthrough
science move forward and the progress confirms our view that
advanced molecular medicine has the potential to offer breakthrough
treatments in areas of serious unmet clinical needs. We
look forward to updating the market on progress with these and our
other preclinical projects in due course.'
Enquiries
Ark Therapeutics
plc
Tel: +44 (0)20 7388 7722
Dr Nigel Parker, Chief Executive Officer
Martyn Williams, Chief Financial Officer
Financial
Dynamics
Tel: +44 (0)20 7831 3113
David Yates / Sue Quigley
Notes to Editors
Ark Therapeutics Group plc
Ark Therapeutics Group plc is a specialist
healthcare group (the 'Group') addressing high value areas of unmet
medical need within vascular disease, wound care and cancer.
These are large and growing markets, where opportunities exist for
effective
new products to generate significant revenues. With four marketed
devices, Kerraboot®, Kerraped®,
Flaminal® and Neuropad®, and three further
lead pharmaceutical products in late stage clinical
development:
Cerepro®, Vitor*, and Trinam®, the Group is
transitioning from an R&D company to a commercial, revenue
generating business.
Ark's own products are sourced from related but
largely non-dependent technologies within the Group and have been
selected to enable them to be taken through development within the
Group's own means and to benefit from Orphan Drug Status and/or
Fast
Track Designation, as appropriate. This strategy has allowed
the Group to retain greater value and greater control of clinical
development timelines, and to mitigate the risks of dependency on
any one particular programme or development partner. Ark
has
secured patents or has patent applications pending for all its lead
products in principal pharmaceutical markets.
Ark has its origins in businesses established in
the mid-1990s by Professor John Martin and Mr Stephen Barker of
University College London and Professor Seppo Yla-Herttuala of the
AI Virtanen Institute at the University of Kuopio, Finland, all of
whom
play leading roles in the Company's research and development
programmes.
Ark's shares were first listed on the London
Stock Exchange in March 2004 (AKT.L).
This announcement includes 'forward-looking
statements' which include all statements other than statements of
historical facts, including, without limitation, those regarding
the Group's financial position, business strategy, plans and
objectives of
management for future operations (including development plans and
objectives relating to the Group's products and services), and any
statements preceded by, followed by or that include forward-looking
terminology such as the words 'targets', 'believes',
'estimates', 'expects', 'aims', 'intends', 'will', 'can', 'may',
'anticipates', 'would', 'should', 'could' or similar expressions or
the negative thereof. Such forward-looking statements involve known
and unknown risks, uncertainties and other important
factors beyond the Group's control that could cause the actual
results, performance or achievements of the Group to be materially
different from future results, performance or achievements
expressed or implied by such forward-looking statements. Such
forward-looking statements are based on numerous assumptions
regarding the Group's present and future business strategies and
the environment in which the Group will operate in the future.
Among the important factors that could cause the Group's
actual
results, performance or achievements to differ materially from
those in forward-looking statements include those relating to Ark's
funding requirements, regulatory approvals, clinical trials,
reliance on third parties, intellectual property, key
personnel
and other factors. These forward-looking statements speak only as
at the date of this announcement. The Group expressly disclaims any
obligation or undertaking to disseminate any updates or revisions
to any forward-looking statements contained in this
announcement to reflect any change in the Group's expectations with
regard thereto or any change in events, conditions or circumstances
on which any such statements are based. As a result of these
factors, readers are cautioned not to rely on any
forward-looking statement.
Posted: May 2008
