Data show that the administration of Rhenium-186 NanoLiposome (186RNL) via convection-enhanced delivery for recurrent glioblastoma is well tolerated at significantly higher doses of radiotherapy than standard modalities
Company and academic staff outline plans for Phase 1 dose determination and efficacy trial of 186RNL for pediatric brain tumors, to commence in mid-2022
AUSTIN, Texas, Aug. 21, 2021 (GLOBE NEWSWIRE) — Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a U.S. clinical-stage pharmaceutical company developing innovative, targeted radiotherapies for rare and difficult-to-treat cancers, today presented data from the NIH-supported ReSPECTTM Phase 1 clinical trial to evaluate the lead investigational drug, Rhenium-186 NanoLiposome (186RNL), in relapsed glioblastoma (GBM). Data from the study show that the delivery of 186RNL, which is designed to allow 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 standard treatment modalities such as external radiation therapy (EBRT).
These data are presented as an E-Poster video titled “A Two-Part, Phase 1 Study of Rhenium-186 NanoLiposome (186RNL) Delivered by Convection-enhanced Delivery for Relapsed, 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 will be held virtually from August 21-25, 2021.
“The ReSPECTTM study demonstrates how 186RNL can safely, effectively, and conveniently deliver very high doses of radiation directly to adult brain tumors,” 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 the ReSPECT™ clinical trial for relapsed GBM in adults:
The mean dose of 186RNL when coverage was 75% or greater (n=10) was 392 Gy (CI 306–478). The treatment was well tolerated, no dose-limiting toxicity or serious side effects were observed (n=18).
“We would like to explore the use of 186RNL in children with different types of childhood brain tumors,” said Marc Hedrick, MD, 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 in a unique position to rapidly move RNL forward to treat these difficult problems in children.”
In addition, the company presented plans for a proposed two-part, phase 1 dose-finding study followed by an extension cohort to investigate the efficacy of 186RNL in pediatric patients with brain tumors. In part one of the study, up to 18 subjects will be enrolled to determine the maximum attainable dose of 186RNL delivered by CED with a 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 in three different cohorts based on their specific disease diagnosis. The primary endpoint of the study will be 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 in this study is expected to begin in 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 the presentations go live on 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 various cancer targets. Central to the company’s drug development is a unique nanotechnology platform designed to reformulate, deliver and commercialize multiple drugs against rare cancers and other diseases. The platform is designed to enable new delivery approaches and/or formulations of safe and effective injectable drugs, potentially improving safety, efficacy and convenience for patients and caregivers. More information can be found at PlusTherapeutics.com and ReSPECT-Trials.com.
Warning Regarding Forward-Looking Statements
This press release contains statements that may be considered “forward-looking statements” within the meaning of United States securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements can be identified by future verbs, as well as terms such as “will”, “believe”, “plan”, “may”, “enable”, “design”, “intend”, “potentially”, ” expect”, “estimate”, “project”, “prospect”, “target”, “focus”, “anticipate”, “could”, “would” and similar expressions or their negatives. Such statements are based on certain assumptions and judgments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors that they deem appropriate. These statements include, without limitation, statements regarding the following: the design and potential of the Plus Therapeutics portfolio to reformulate, deliver and commercialize multiple new, proprietary drugs for rare cancers and other diseases, and to develop new approaches to delivery and/or formulations of safe and effective injectable drugs; the potential of the company’s in-licensed portfolio of investigational drugs; the company’s intent to enhance its CNS oncology portfolio through the clinical development process; the ability of RNL to safely, effectively and conveniently deliver a very high dose of radiation directly into the brain tumor; expected benefits from strategic partnerships and licensing agreements, intellectual property, FDA approval process and government regulation; and the Company’s anticipated milestones and events, including related to additional locations, enrollment, pivotal study planning, IND process and clinical phase plans for RNL, pipeline expansion through additional drug candidate development, and partnership discussions for RNL, DocePLUS and DoxoPLUS; and future development and/or expansion of its product candidates and therapies in its markets. The forward-looking statements in this press release are subject to a number of risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that the company will not be able to successfully develop product candidates that can leverage the FDA’s accelerated regulatory pathways; the early stage of the Company’s product and therapeutic candidates, the results of its research and development activities, including uncertainties related to the clinical trials of its product and therapeutic candidates; the company’s history of losses; the company’s need for and ability to raise additional funds or obtain other sources of financing in the near future; the Company’s ability to: (a) obtain and maintain regulatory approvals, (b) continue as a going concern, (c) remain listed on the Nasdaq Capital Market, (d) adequate fees for its testing to obtain or maintain, and (d) to repay or refinance any or all of its outstanding debts; the outcome of the company’s collaborative/licensing efforts; market and economic conditions; the impact of the COVID-19 pandemic on the Company and the effectiveness of the efforts it has made or may make in the future to respond to it; and additional risks described under the heading “Risk Factors” in the Company’s filings with the Securities and Exchange Commission, including in the Company’s annual and quarterly reports. Events may occur in the future that the Company cannot predict or control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or conditions after the date they are made, unless the Company has an obligation under US federal securities laws to do so.
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