Ark Therapeutics Study Confirms Therapeutic Effect of Vitor(TM) in Cancer Cachexia
Ark Therapeutics Group plc announced 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.
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