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Vitor™ 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™ 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™ 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™ 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™ 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™ on rate of weight change became evident in all cancer types. Pancreatic cancer patients on Vitor™ 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™ 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™. The safety profile showed Vitor™ 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™ treatment group on virtually all clinical endpoints measured. We have therefore seen a definite therapeutic effect from Vitor™ 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™ produces. The potential for efficacy combined with an established safety profile makes Vitor™ 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™ 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™ and cachexia in cancer
Vitor™ 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™ 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 Ylä-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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