Plus, Therapeutics Inc. (NASDAQ:PSTV) has announced that it has received Fast Track Designation from the FDA for its investigational treatment of Rhenium Nanoliposomes in treating recurrent glioblastoma patients.
Grant of Fast Track Designation important in advancing RNL development program
The Fast track design grant comes at the back of previously announced orphan drug designation for RNL from the FDA for glioblastoma treatment. There are several benefits attached to the grant of Fast track Designation in a drug development program. They include frequent FDA meetings to discuss the development plan of the drug and continuous communication from the FDA regarding the design of purposed clinical trials and biomarkers use. Another advantage is the eligibility for Priority Review and accelerated approval should the company meet relevant criteria. There is an equally rolling review, which means that the company can submit complete sections for NDA review instead of waiting to complete all sections before submitting an NDA application.
Dr. Marc Hedrick, the CEO and President of Plus Therapeutics, stated that the grant of Fast Track designation validates the potential significance of RNL as a radiotherapeutic treatment for recurrent glioblastoma patients that currently don’t have good treatment alternatives available. He added that with the designation, the company plans to proceed into Cohort 6 of the ReSPECT(TM trial. This will be a step closer to having a novel therapy for the glioblastoma patient population.
Cohort 6 of the trial approved to proceed
Plus, Therapeutics is evaluating RNL in the multi-center ReSPECT™ first phase dose fining study that is NIH/NCI-supported. Recently the company indicated that the Data and Safety Monitoring Board of the ReSPECT trials had approved the advancement of Cohort 6 that includes an increase in radiation doses and drug volume by 22.3 millicuries and 8.8 milliliters, respectively.
The company designed RNL to effectively, safely, and conveniently deliver a high dose of radiation directly into the brain tumor for enhanced maximum effect. The increase in radiation dose is almost 25 times more concentrated than the external beam radiation therapy currently used.