Plus Therapeutics Announces Plans for Treating Pediatric Brain Cancer

AUSTIN, Texas, Aug. 21, 2021 -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a U.S. clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, today presented data from the NIH-supported ReSPECTTM Phase 1 clinical trial evaluating its lead investigational drug, Rhenium-186 NanoLiposome (186RNL), in recurrent glioblastoma (GBM). Data from the trial shows that the administration of 186RNL, which is designed to allow for targeted beta radiation to the tumor via convection enhanced delivery (CED) with limited exposure to surrounding tissues, was well tolerated in adult patients with recurrent GBM at significantly higher doses than with standard treatment modalities such as external beam radiation therapy (EBRT).
This data is being presented as an E-Poster video entitled “A two-part, Phase 1 study of Rhenium-186 NanoLiposome (186RNL) delivered by convection enhanced delivery for recurrent, refractory, or progressive ependymoma and high-grade glioma (HGG) and newly diagnosed diffuse intrinsic pontine glioma (DIPG)” at the 2021 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting, which is being held virtually August 21-25, 2021.
“The ReSPECTTM trial demonstrates how 186RNL can deliver a very high dose of radiation directly to adult brain tumors safely, effectively and conveniently,” said Michael G. DeCuypere, MD, PhD, FAANS, Northwestern University Feinberg School of Medicine, and presenter of the E-Poster. “Children with brain tumors have limited options and 186RNL delivered with a minimally invasive procedure could be an important new potential option for these patients.”
Additional key findings from ReSPECT™ clinical trial for adult recurrent GBM:
The mean dose of 186RNL when coverage was 75% or greater (n=10) was 392 Gy (CI 306 - 478).
The treatment has been well tolerated, with no dose-limiting toxicity or serious adverse events observed (n=18).
“We are eager to explore the use of 186RNL in children with pediatric brain tumors of various types,” stated Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. “Dr. DeCuypere and the team at Lurie Children’s Hospital in Chicago have been great academic partners and are uniquely positioned to bring RNL forward rapidly to treat these tough problems in children.”
In addition, the Company presented plans for a proposed two-part, Phase 1 dose-finding study to be followed by an expansion cohort to explore the efficacy of 186RNL in pediatric patients with brain tumors. Part one of the trial will enroll up to 18 subjects to determine the maximum feasible dose of 186RNL administered by CED with the tumor diameter limited to four centimeters and a volume of 34 milliliters. While Part two of the study will independently evaluate 186RNL in up to 39 patients across three different cohorts based on their specific disease diagnosis. The primary endpoint of the study will be the overall response rate, and the secondary endpoints will include progression free survival-24 and overall survival-24 or progression free survival-12 and overall survival-12 in cohort A and cohorts B and C, respectively. Patient enrollment for this study is expected to begin by mid 2022.
A copy of the presentation will be made available under the Presentations tab of the Investors section of the Company’s website when presentations go live at www.plustherapeutics.com.
About Plus Therapeutics, Inc.
Plus Therapeutics (Nasdaq: PSTV) is a clinical-stage pharmaceutical company whose radiotherapeutic portfolio is concentrated on nanoliposome-encapsulated radionuclides for several cancer targets. Central to the Company’s drug development is a unique nanotechnology platform designed to reformulate, deliver and commercialize multiple drugs targeting rare cancers and other diseases. The platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at PlusTherapeutics.com and ReSPECT-Trials.com.
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