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RNS Number:9512W
Ark Therapeutics Group PLC
16 January 2006
Ark Therapeutics Group plc
Full Analysis of Vitor(TM) Study Confirms Therapeutic Effect in Cancer Cachexia
Vitor(TM) significantly slows progression of cachexia in two cancer types and
statistical significance achieved in two secondary endpoints across all cancers
Confirmatory Phase III trial to be planned with the Regulators
16 January 2006, London UK: Ark Therapeutics Group plc today announces the full
analysis from the first safety and efficacy study of Vitor(TM) in cancer
cachexia. The results are consistent with the preliminary results previously
announced on 28 October 2005 and provide additional statistical confirmation.
The study examined whether Vitor(TM) changes the pattern of cancer cachexia
(unintentional weight loss) in three types of cancer: colorectal, non-small cell
lung (NSCL) and pancreatic cancer. 200 patients with cancer cachexia were
included in the study.
Full results from patients completing the study showed the reduction in the rate
of cachexia in patients with NSCL and colorectal cancer following treatment with
Vitor(TM) was statistically significant (p<0.028). Statistical significance
was
not achieved in patients with pancreatic cancer (the more aggressive of the
cancers studied). The combined analysis of all three cancer types for the
primary endpoint of overall weight loss showed that, whilst treated patients on
average lost 29% less weight than untreated patients, the difference did not
reach statistical significance (p>0.05). The statistical results in the
primary
endpoints were principally confounded by pancreatic cancer patients showing a
different response from the other two cancer types and a large proportion (42%)
of study non-completers causing high variability in the data. For the co-
primary endpoint of hand grip strength across all cancers, Vitor(TM) treatment
attenuated the reduction in mean hand grip strength by 42% compared with placebo
but the results did not reach statistical difference. Statistical significance
was reached in two secondary endpoints, extent of fatigue since last visit
(p<
0.039) and level of fatigue at the reporting time (p<0.0072).
Patients had lost an average of 15% body weight (av. 24 lbs) in the six months
prior to entering the study. The rate of weight loss on entering the study
slowed markedly in both treated and untreated groups. It is possible that
because patients had lost so much weight prior to entry, they could lose little
more; however, a 'study entry' effect may have existed. Nevertheless, the trial
population lost an average of 2.3lbs during the 12 week period with treated
patients losing an average of 1.91lbs and controls 2.68lbs. After four weeks in
the study, the beneficial effect of Vitor(TM) on rate of weight change became
evident in all cancer types. Pancreatic cancer patients on Vitor(TM) on average
lost 0.020lbs/day from week 4 to week 12 with controls losing 0.061lbs/day and
NSCL and colon cancer patients showed average net weight gains of +0.0025lbs/day
on Vitor(TM) whilst controls lost 0.022lbs/day. The patients who had lost the
most weight on study entry appeared to show the greatest response to Vitor(TM).
The safety profile showed Vitor(TM) to be well tolerated and the study did not
reveal any unexpected events.
Professor John Martin, Chief Scientific Officer at Ark, commented: 'These
results are both scientifically and clinically encouraging. Although there is
variation in the data across the cancer and patient types, there is a consistent
difference in favour of the Vitor(TM) treatment group on virtually all clinical
endpoints measured. We have therefore seen a definite therapeutic effect from
Vitor(TM) and we now have to work with the understanding gained to refine how we
assess this disease and take the product forward so that cachexia patients can
benefit from the clinical effects Vitor(TM) produces. The potential for
efficacy combined with an established safety profile makes Vitor(TM) a very
promising agent.'
Dr David Eckland, R&D Director at Ark, added: 'Ark will now be working to apply
the information gained from this study into the design of a confirmatory Phase
III trial of Vitor(TM) in cancer cachexia and we expect to be discussing this
with
the regulators in the near future.'
For further information please contact:
Ark Therapeutics +44 (0)20 7388 7722
Dr Nigel Parker, Chief Executive Officer
Martyn Williams, Chief Financial Officer
Financial Dynamics +44 (0)20 7831 3113
David Yates / Davina Langdale
Notes to Editors
Vitor(TM) and cachexia in cancer
Vitor(TM) is an oral small molecule therapy for the treatment of muscle wasting
(cachexia), a secondary, often fatal, condition commonly seen in patients with
cancer. The active ingredient was originally developed as a treatment for high
blood pressure and is currently marketed in Japan and certain countries in
Europe. Vitor(TM) has been shown to up-rate the ability of mitchondria to
produce energy. In addition by working on the ubiquitin proteasome pathway, it
prevents the breakdown of muscle proteins (actin and myosin) and reverses the
impaired muscle protein production, which both occur as a result of the action
of chemicals secreted by the cancer tumour and lead to the weight loss.
Ark Therapeutics Group plc
Ark is an emerging healthcare group (the 'Group') now entering the
commercialisation phase, with one product introduced into hospitals and three
further lead products in late stage clinical development. Capitalising on over
ten years of research in vascular biology and gene-based medicine, Ark has a
balanced portfolio of proprietary healthcare products targeted at specific unmet
clinical needs within vascular disease and cancer. These are large and growing
markets, where opportunities exist for effective new products to generate
significant revenues.
Ark's products are sourced from related but largely non-dependent technologies
within the Group and have been selected to enable Ark to take each product
through development and to benefit from Orphan Drug Status and/or Fast Track
Designation, as appropriate. The Group generally retains ownership of its
product candidates throughout clinical development. Ark has secured patents or
has patent applications pending for all its lead products in principal
pharmaceutical markets and retains the right to market its lead products in the
key North American and European 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 successfully listed through an initial public offering 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.
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