Tavocept falls short in Ph III neuropathy trials

Japanese drugmaker Takeda and the USA's BioNumerik Pharmaceuticals say that the chemo-protective agent Tavocept (dimesna) has fallen short of the primary endpoints in two Phase III neuropathy trials. The clinical program was focused on assessing the drug as a preventative treatment for chemotherapy-associated nerve damage.

Both studies, which were carried out at research centers in the USA, Russia and the Ukraine, were designed to compare the effect of the drug versus placebo on the incidence of neuropathy caused by the administration of a cisplatin- or paclitaxel-based chemotherapy regimen. Analysis of the results revealed that the product did not reduce pain-associated nerve damage, or cause objective tumor response, to a level of statistical significance.

Commenting on the findings, Frederick Hausheer, BioNumerik's chairman, said that the firm maintains the belief that the drug has sufficient potential in the neuropathy indication to merit further development. Dr Hausheer explained that this opinion was based on the subsequent analysis of certain patient subgroups from the larger study population. Takeda said that, following the disappointing results, it would consider all options relating to its licensing agreement with the San Antonio-headquartered firm.