Quercis Pharma AG, a private, clinical stage biopharmaceutical company, announced on Tuesday that it has signed a Special Protocol Assessment (SPA) agreement with the United States Food and Drug Administration (FDA) for the protocol named 'A Randomized, Placebo-Controlled, Double-Blind Phase 3 Trial Comparing, Relative to Placebo, the Effect of Isoquercetin on Thromboembolic Events in Patients with Metastatic Pancreatic Cancer (CATIQ P3).'

Isoquercetin, the firm's lead product candidate, uses a novel pathway that is based on a new mechanism of action to prevent or reverse thrombus formation with a profile that potentially conveys substantially decreased bleeding risk compared to present standard of care.

According to the SPA agreement, the Phase three study will be a randomised placebo-controlled trial in which patients will receive either 1000 mg or 2000 mg of oral isoquercetin (formulated with vitamin C and vitamin B3) or matching placebo capsules daily for 16 weeks. The agreed upon primary endpoints of the study are the comparison of plasma D-dimer at baseline and at day 56 and the development of any symptomatic proximal or distal deep vein thrombosis (DVT), symptomatic pulmonary embolism (PE) or fatal PE, asymptomatic proximal DVT at the end of treatment period. The Company also plans to initiate a second randomised placebo-controlled Phase 3 trial with a similar design in glioblastoma patients, and on the basis of both trials it plans to pursue FDA approval for the prevention of VTE in all cancer types.