Plus Therapeutics Presents at the Sixth Biennial Pediatric Neuro-Oncology Research Conference
Plus Therapeutics (PSTV) announced a poster presentation at the 6th Biennial Pediatric Neuro-Oncology Research Conference. The poster focuses on a Phase I study of Rhenium-186 Nanoliposomes (186RNL) for treating ependymoma and high-grade glioma. Dr. Ashley S. Plant-Fox from Northwestern University leads the presentation. The FDA has provided positive feedback on their study synopsis and confirmed no additional toxicology studies are needed for pediatric trials. RNL has also received Orphan Drug and Fast Track designations for glioblastoma treatment.
- Successful poster presentation at a prominent conference, increasing visibility.
- Positive FDA feedback on study synopsis and no additional toxicology studies required.
- RNL received Orphan Drug and Fast Track designations for glioblastoma, enhancing potential market access.
- None.
AUSTIN, Texas, June 10, 2021 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company, today announced 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.
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).
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 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.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “will,” “believe,” “plan,” “can,” “enable,” “design,” “intend,” “potential,” “expect,” “estimate,” “project,” “prospect,” “target,” “focus,” “anticipate,” “could,” “should,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be 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 novel, proprietary drugs targeting rare cancers and other diseases and to facilitate new delivery approaches 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 advance 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; anticipated benefits of strategic collaborations and license agreements, intellectual property, FDA approval process and government regulation; and the Company’s anticipated milestones and events, including with respect to additional sites, enrollment, pivotal trial planning, IND process, and clinical phase plans for RNL, pipeline expansion through additional drug development candidates, 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 included in this press release are subject to a number of risks and uncertainties that may 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 is not able to successfully develop product candidates that can leverage the FDA’s accelerated regulatory pathways; the early stage of the Company’s product candidates and therapies, the results of its research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s history of losses; the Company’s need for, and ability to raise, additional cash or obtain other sources of funding in the immediate 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) to obtain or maintain sufficient levels of reimbursement for its tests, and (d) to repay or refinance some or all of its outstanding indebtedness; the outcome of the Company’s partnering/licensing efforts; market and economic conditions; the impact of the COVID-19 pandemic on the Company and the effectiveness of the efforts it has taken or may take in the future in response thereto; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no 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 circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
Westwicke/ICR
(443) 377-4767
Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
Westwicke/ICR
(203) 856-4326
Terri.Clevenger@westwicke.com
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