AUSTIN, Texas, June 10, 2021 (GLOBE NEWSWIRE) — Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company, today announced that it will present a poster at the 6th Biennial of Pediatrics Neuro-Oncology Research Conference hosted by the Society for Neuro-Oncology (SNO) , which will be held virtually June 10-12, 2021.
The poster presentation is titled, “A Phase I Two-Part Study of Rhenium-186 Nanoliposomes (186RNL) Delivered by Convection Enhanced Delivery (CED) for Relapsed, Refractory or Progressive Ependymoma and High-Grade Glioma (HGG).” The main presenter is Dr. Ashley S. Plant-Fox, attending physician, neuro-oncology, assistant professor of pediatrics, and AM Khokhar Research Scholar at Northwestern University Feinberg School of Medicine and Ann & Robert H. Lurie Children’s Hospital in Chicago. A copy of the poster is available under the Presentations tab of the Investors section of the company’s website. The data presented includes an overview of relevant preclinical research, the company’s Phase 1 ReSPECTTM clinical trial in relapsed glioblastoma (GBM) and a proposed design to initiate a Phase I clinical trial in pediatric brain tumors.
RNL™, the company’s lead investigational drug, is a new radiotherapy designed to potentially deliver very high doses of radiation directly to brain tumors, safely, effectively and conveniently.
The company recently received feedback from the US Food and Drug Administration (FDA) regarding the submitted Pre-Investigational New Drug meeting package. In summary, the FDA provided constructive feedback on the study synopsis that should be helpful if a full protocol is developed, and confirmed that no additional GLP toxicology studies are needed to support the initiation of a pediatric clinical trial.
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™ study are available at clinicaltrials.gov (NCT01906385).
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 injectable drugs, potentially improving safety, efficacy and convenience for patients and healthcare providers. 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 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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