� Ark Therapeutics Group plc ("Ark" or the "Company") announces that enrolment of patients into its Phase III pilot study for VitorTM (Study 208) has commenced. VitorTM is Ark's mathematical product to treat cachexia (involuntary muscle wasting) associated with cancer.
Study 208 is a blinded, randomised, placebo controlled, multicentre trial in up to 64 patients being conducted in fivesome countries in Europe. The trial will study the effect of VitorTM on patients with non-small cell lung cancer who ar already experiencing clinical signs of cachexy. Patients volition be assessed for their rate of muscle wasting away during an initial blinded study dustup period of up to 6 weeks, and thereafter randomised to active or control treatment for a further 12 week period. Total weight loss, lean body multitude and early physical markers of cachexy will be assessed victimization a variety of methodologies. The study results will provide data to support the pattern of the final Phase III program.
VitorTM has been awarded Fast Track Status by the FDA reflecting the high clinical need for an in effect product to treat cachexy, which affects up to 70% of patients with solid tumours and is the nearly frequently reported cause of death in these patients. A Special Protocol Assessment (SPA) serve was opened with the FDA in 2007. The Company is expected to enter broad Phase III development in 2009 following completion of this archetype study.
A Phase II/III study of VitorTM in 165 patients has already been completed in the USA and Europe, where treatment showed a substantial effect compared with placebo in reducing the rate of day-by-day weight loss in patients with small-scale cell lung and colon cancer.
Nigel Parker, CEO of Ark, commented: "Having secured approvals from all the versatile committees in the countries involved in the test, we ar pleased to report this clinical progression on VitorTM with patients entering the trial as expected. We look ahead to providing an update on the trial's progression in due course."
VitorTM and wasting in cancer
Vitor� is an oral small molecule therapy for the treatment of muscle cachexy (cachexia), a secondary, frequently fatal, precondition commonly seen in patients with cancer. The dynamic ingredient was originally developed as a treatment for high blood pressure and is presently marketed in Japan and certain countries in Europe. Pre-clinical work has shown Vitor� up-rates the power of mitchondria to farm energy. In addition, by working on the ubiquitin proteasome footpath, it prevents the dislocation of muscleman proteins (actin and myosin) and reverses the impaired muscle protein production, which both pass as a result of the action of chemicals secreted by the crab tumour and lead to weight red. Ark estimates that 1.5 million new cases of crab cachexia come every yr in the US and Europe yet few handling options presently exist.
Ark Therapeutics Group plc
Ark Therapeutics Group plc is a specialist healthcare group (the "Group") addressing high value areas of unmet medical need inside vascular disease, wound precaution and cancer. These ar large and growing markets, where opportunities exist for effective novel products to generate pregnant revenues. With four marketed devices, Kerraboot�, Kerraped�, Flaminal� and Neuropad�, and leash further pb 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 possess products are sourced from related merely largely non-dependent technologies within the Group and consume been selected to enable them to be taken through evolution within the Group's possess means and to benefit from Orphan Drug Status and/or Fast Track Designation, as reserve. This strategy has allowed the Group to hold greater value and greater control of clinical ontogenesis timelines, and to mitigate the risks of colony 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 number one listed on the London Stock Exchange in March 2004 (AKT.L).
This annunciation includes "advanced statements" which include all statements other than statements of historical facts, including, without limitation, those regarding the Group's financial place, business strategy, plans and objectives of management for future trading operations (including development plans and objectives relating to the Group's products and services), and whatsoever statements preceded by, followed by or that let in forward-looking nomenclature such as the language "targets", "believes", "estimates", "expects", "aims", "intends", "will", "tin", "may", "anticipates", "would", "should", "could" or similar expressions or the negative thereof. Such advanced statements regard known and unknown risks, uncertainties and other important factors beyond the Group's control that could cause the literal results, performance or achievements of the Group to be materially different from future results, performance or achievements explicit or implied by such forward-looking statements. Such advanced statements ar based on numerous assumptions regarding the Group's present and succeeding 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 disagree materially from those in forward-looking statements include those relating to Ark's support requirements, regulatory approvals, clinical trials, reliance on one-third parties, intellectual property, key personnel and other factors. These innovative statements speak only as at the date of this announcement. The Group expressly disclaims any duty or labor to disseminate any updates or revisions to any forward-looking statements contained in this announcement to reflect any variety in the Group's expectations with respect 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 non to swear on whatever forward-looking statement.
Ark Therapeutics Group plc
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