Pharmaceutical Business review

Wellstat Releases Investigational Drug Uridine Triacetate Clinical Results

Wellstat Therapeutics said that while no antidote for 5-FU overexposure has been approved by regulatory authorities, Uridine triacetate (formerly known as vistonuridine) has been made available to physicians for emergency use.

Wellstat Therapeutics’ trial was made on 37 cases of 5-FU overexposure, all of them treated with Uridine triacetate. In all of these cases, the patients recovered from the overexposure, even though a fatal outcome for at least 27 of them would have been predicted by the dose and rate of 5-FU administration. In one extreme case, the patient survived after receiving a 5-FU dose 10 times higher than intended (10,000mg in three hours instead of 1,000mg in one hour).

Reportedly, in all cases, the emergency treatment commenced as rapidly as possible after 5-FU overexposure (within 8 to 96 hours), depending on the timing of the request to Wellstat and the location of the treatment site.

Michael Bamat, vice president of research and development at Wellstat, said: “Since our first report on uridine triacetate at ASCO in 2009, the number of patients treated with this investigational antidote has more than doubled.”