On November 9, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported that the U.S. Food and Drug Administration (FDA) has granted the Company Fast Track designation for Rhenium-186 NanoLiposome (186RNL) for the treatment of leptomeningeal metastases (LM), a rare complication in which the disease spreads to the membranes (meninges) surrounding the brain and spinal cord, affecting nearly 5% of people living with cancer (Press release, Cytori Therapeutics, NOV 9, 2021, View Source [SID1234594850]). The Company recently announced clearance of its Investigational New Drug (IND) application from the FDA, and expects to initiate patient accrual in the ReSPECT-LM Phase 1 dose escalation clinical trial of 186RNL in the fourth quarter of 2021.
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"The incidence of LM is rising and represents a rapidly progressing and fatal complication of several cancer types," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "Based on our clinical experience with 186RNL in glioma and preclinical studies in LM models, we are optimistic that 186RNL may have a therapeutic role in management of this increasingly common cancer."
Fast Track designation confers several benefits to the drug development program including 1) more frequent meetings with FDA to discuss the drug’s development plan, 2) more frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers, 3) eligibility for Accelerated Approval and Priority Review, if relevant criteria are met, and 4) Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA.
About the ReSPECT-LM Study
The ReSPECT-LM clinical trial is a multicenter, sequential cohort, open-label, single dose, dose escalation Phase 1 study. It will evaluate the maximum tolerated dose, maximum feasible dose, safety, and efficacy of a single administration of 186RNL via intraventricular catheter for LM following standard surgical, radiation, and/or chemotherapy treatment. The primary endpoint of the study is the incidence and severity of adverse events/serious adverse events and dose limiting toxicities. Secondary endpoints include overall response rate, duration or response, progression free survival, and overall survival.
About Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the disease spreads to the membranes (meninges) surrounding the brain and spinal cord. LM occurs in approximately 5% of people with cancer, or 110,000 people in the U.S. each year, and is usually terminal with a median survival of approximately 2-3 months following treatment. LM occurs with cancers that are most likely to spread to the central nervous system. The most common cancers to include the leptomeninges are breast cancer, lung cancer, and melanomas.