PVG.L Regulatory News (PVG)

16 Jan 2006 07:01

Ark Therapeutics Group PLC16 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 andstatistical 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 fullanalysis 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 rateof cachexia in patients with NSCL and colorectal cancer following treatment withVitor(TM) was statistically significant (p0.05). The statistical results in the primaryendpoints were principally confounded by pancreatic cancer patients showing adifferent 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) treatmentattenuated the reduction in mean hand grip strength by 42% compared with placebobut the results did not reach statistical difference. Statistical significancewas reached in two secondary endpoints, extent of fatigue since last visit (p<0.039) and level of fatigue at the reporting time (p