When the data and safety monitoring board (DSMB) for Biocardia Inc.’s phase III pivotal trial of its Cardiamp cell therapy for heart failure advised pausing the study in July to analyze the interim results, the company expressed confusion as there were no reported treatment-emergent safety issues and aggregated blinded data showed better than expected outcomes. With the recommended external analysis now complete, the company confirmed the study is unlikely to achieve its primary endpoint at one year. The trial has now been unblinded.
Torl Biotherapeutics LLC has raised $158 million in a series B round as it seeks to nudge its anti-Claudin-6 antibody-drug conjugate candidates, TORL-123 and TORL-2307, beyond phase I trials for the treatment of ovarian and gastric cancers, respectively. Claudin-6, or CLDN6, is a molecule that forms tight junctions around cells. It is highly expressed in a range of solid tumor types, so is a popular target for drug development.
SAO PAULO, Brazil – Latin America is rife with opportunities to undertake clinical trials, but regulatory adjustments are needed for companies to fully take advantage of them. As the largest market in the region, Brazil, for one, is in dire need of those adjustments, said experts gathered in Sao Paolo last week for the annual BIO Latin America conference.
MEXICO CITY – Ten years after the RV144 "Thai trial" was the first to show that an effective HIV vaccine was possible, three efficacy trials for HIV vaccines are once again underway.