Valens Pharma reports top-line results from voluntary Phase II trial
Valens Pharma Ltd. announced preliminary results from its voluntary Phase II "Mini-Metr*ics" clinical trial evaluating its proprietary intravenous formulation of dichloroacetate (DCA i.v.) in high risk, geriatric patients undergoing open heart surgical procedures. A primary objective of this exploratory Phase II study was to collect key information to help design further trials. A secondary objective was to determine if there was evidence of clinical efficacy for endpoints that included reduced time in the Intensive Care Unit for this patient group. Evidence of efficacy for those endpoints was not revealed in this pilot study. However, as expected, the biochemical benefits of DCA shown in earlier trials, such as lower plasma lactate levels and lower, more stable levels of glucose, were confirmed among treated patients.
"A thorough analysis of the data from this trial, when received, is expected to provide key knowledge required for further clinical development of DCA i.v., including information regarding the dosage regimen for high risk geriatric patients and other measures of successful outcomes," commented Dr. Ruth Collins-Nakai, Chief Medical Officer for the Company.
The Phase II trial encompassing 83 patients, was a randomized, double blind, placebo controlled trial, conducted at the University of Alberta, in Edmonton. Patients in the study group received a bolus infusion of DCA i.v. immediately post surgery followed by a continuous infusion of DCA i.v. for a 24 hour period. DCA i.v., had been evaluated in three previous clinical trials involving 109 cardiac patients, but this was the first time the drug had been tested under this dose regimen in an elderly population with a higher risk profile.
Other news from the department research and development
