On June 10, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company, reported it will present a poster at the 6th Biennial Pediatric Neuro-Oncology Research Conference hosted by the Society for Neuro-Oncology (SNO), being held virtually June 10-12, 2021 (Press release, Cytori Therapeutics, JUN 10, 2021, View Source [SID1234583876]).
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The poster presentation is titled, "A two-part, Phase I study of Rhenium-186 Nanoliposomes (186RNL) delivered by convection enhanced delivery (CED) for recurrent, refractory, or progressive ependymoma and high-grade glioma (HGG)." The lead presenter is Dr. Ashley S. Plant-Fox, Attending Physician, Neuro-Oncology, Assistant Professor of Pediatrics, and A.M. Khokhar Research Scholar at the Northwestern University Feinberg School of Medicine and the Ann & Robert H. Lurie Children’s Hospital of Chicago. A copy of the poster is available under the Presentations tab of the Investors section of the Company’s website. Presented data include a review of relevant preclinical research, the company’s Phase 1 ReSPECTTM clinical trial in recurrent glioblastoma (GBM) and a proposed design for initiating a Phase I clinical trial in pediatric brain tumors.
RNL, the Company’s lead investigational drug, is a novel radiotherapy that is designed to potentially deliver a very high dose of radiation directly to brain tumors safely, effectively and conveniently.
The company recently received feedback from the U.S. Food and Drug Administration (FDA) regarding its submitted Pre-Investigational New Drug meeting package. Briefly, the FDA provided constructive feedback on the study synopsis that should be helpful as a full protocol is developed, and confirmed that no additional GLP toxicology studies are required to support initiation of a pediatric clinical study.
The FDA has granted both Orphan Drug designation and Fast Track designation to RNL for the treatment of patients with GBM. Additional details about the ReSPECT trial are available at clinicaltrials.gov (NCT01906385).