FDA Grants Fast Track Designation to Plus Therapeutics for Targeted Radiotherapeutic
November 9, 2021
The U.S. Food and Drug Administration granted Fast Track designation to Plus Therapeutics for Rhenium-186 NanoLiposome (186RNL), its experimental radiotherapeutic for leptomeningeal metastases, a rare complication of cancer in which the disease spreads to the membranes surrounding the brain and spinal cord.
Leptomeningeal metastases (LM) occur in approximately 5 percent of people with cancer, or 110,000 people in the United States each year. It is usually terminal with a median survival of approximately two to three 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.
Fast Track designation confers several benefits to the drug development program including more frequent meetings with FDA to discuss the drug’s development plan, more frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers, eligibility for Accelerated Approval and Priority Review, if relevant criteria are met, and 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.
The company recently announced clearance of its Investigational New Drug 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.
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 of response, progression free survival, and overall survival.
“The incidence of LM is rising and represents a rapidly progressing and fatal complication of several cancer types,” said Marc Hedrick, president and CEO 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.”
Author: Rare Daily Staff
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