PharmAust Limited announced that following the treatment of 15 pet dogs during its Phase IIa and Phase IIb studies, monepantel (MPL) demonstrated sufficient and statistically significant anti-cancer activity to continue development into Phase III. Multi-centric hig h grade B-cell lymphoma is one of the more aggressive cancers to study in canine oncology. Objective regression in one of the first eight dogs, with some tumours resolving completely, as well as objective stable disease or better in six of the first 15 pet dogs treated over the 28 day trial is a compelling outcome. Two pet dogs with advanced and extensively disseminated disease and one other dog with advanced and less extensively disseminated disease were treated with lower dose MPL, however, these were withdrawn due to disease progression during the trial. The remaining 12 treated pet dogs completed the full 28 day trial period. Published mean and median times for untreated dogs show that normally eight of these 15 pet dogs would have been euthanised by day 29/30 with aggressively progressive disease and poor quality of life1. Comprehensive data are not available ex-trial, but available reports are that at least six pet dogs continued with either MPL alone or in combination with prednisolone. The inappetence and elevated liver enzymes observed at the higher doses of MPL will not be relevant for Phase III. This Phase IIb trial also opens the door for PharmAust and its team of vets to explore the value of MPL in other canine cancers. MPL's ability to target a central metabolic pathway associated with tumour growth (mTOR) provides confidence that MPL will have application in other cancers. Furthermore, having evaluated a range of treatment regimens for MPL during the current trial, the Company has established a therapeutic window for clinical trials in human cancers. Achieving stable disease in primary cancerous lesions as well as in metastatic disease could have substantial value in human cancer therapy particularly if progression-free survival correlates with overall survival. It is noteworthy that achievement of stable disease was observed in PharmAust's previous small Phase I trial in humans where the participants had been admitted with progressive disease following the failure of other treatments.