Plus Therapeutics, Inc. announced that it has expanded its partnership with Medidata. The goal of the expanded partnership is to speed enrollment, improve patient access to an innovative therapy and reduce clinical trial costs in Plus Therapeutics' planned forthcoming Phase 2 registrational trial of Rhenium-186 NanoLiposome (186RNL) in recurrent glioblastoma (GBM). The partnership will utilize Medidata's Synthetic Control Arm (SCA) platform that facilitates the use of historical clinical trial (HCT) data in a manner that historically has been favorably received by the U.S. Food and Drug Administration.

The expanded partnership follows a successful preliminary assessment stage intended to determine project feasibility and probability of success. Medidata will provide the Company with a SCA based on a historical pool of anonymized HCT data to incorporate into Plus Therapeutics' planned Phase 2 trial of 186RNL in recurrent GBM. SCAs are especially advantageous in indications such as recurrent GBM where the standard-of-care control treatment is considered undesirable by many patients and physicians.