Plus Therapeutics Completes Sixth Dosing Cohort in ReSPECT™ Glioblastoma Trial
Plus Therapeutics (Nasdaq: PSTV) has completed the sixth dosing cohort in the ReSPECT™ Phase 1 clinical trial for Rhenium NanoLiposome (RNL™) in recurrent glioblastoma patients. This cohort included increased drug volume to 8.8 milliliters and radiation dose to 22.3 millicuries. Eighteen patients have been treated to date. RNL has received Orphan Drug and Fast Track designations from the FDA, enhancing its development status. No dose-limiting toxicities were observed in interim data, indicating a favorable safety profile.
- Completion of the sixth dosing cohort in the ReSPECT trial for RNL.
- Increased dosage may enhance targeting of malignant cells.
- Eighteen patients treated, demonstrating ongoing trial progress.
- Orphan Drug and Fast Track designations from the FDA for RNL.
- No dose-limiting toxicities reported in interim data.
- None.
AUSTIN, Texas, Dec. 15, 2020 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing novel, targeted and personalized therapies for rare and difficult to treat cancers, today announced completion of the sixth dosing cohort in the ReSPECT™ Phase 1 clinical trial evaluating the Company’s lead investigational asset, Rhenium NanoLiposome (RNL™), in patients with recurrent glioblastoma (GBM).
The sixth cohort of the ReSPECT trial included an increase in both the RNL drug volume and the radiation dose to 8.8 milliliters and 22.3 millicuries, respectively. RNL is designed to safely, effectively and conveniently deliver a very high dose of radiation potentially up to 15 times greater than traditional external beam radiation therapy.
Eighteen patients with recurrent GBM thus far have been treated in the ReSPECT trial. This trial is supported by the U.S. National Institutes of Health/National Cancer Institute at three trial sites in the U.S., including UT Health Science Center San Antonio and UT Southwestern Medical Center.
“The dose escalation design in ReSPECT permits both increases in drug volume and the radiation dose of RNL,” said Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. “This scheme is important as it allows us to potentially better target those malignant cells at the tumor margin that may be the source of future disease progression.”
As previously disclosed, the U.S. Food and Drug Administration 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). Interim data from ReSPECT was disclosed in November 2020 at the Society of Neuro-Oncology Annual Meeting and showed that RNL was well-tolerated, with no dose-limiting toxicity observed in the first 15 patients enrolled in the trial.
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.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains certain statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements, other than statements of historical fact, that address activities, events or developments that we intend, expect, project, believe or anticipate and similar expressions or future conditional verbs such as will, should, would, could or may occur in the future are forward-looking statements. Such statements are based upon certain assumptions and assessments made by our 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 about: the Company’s potential 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; the Company’s potential to develop drug candidates currently in its product pipeline; and the Company’s potential to develop additional drugs outside of its current pipeline. The forward-looking statements included in this press release are subject to a number of additional material risks and uncertainties, including but not limited to: the risk that the Company is not able to successfully develop product candidates that can leverage the U.S. FDA’s accelerated regulatory pathways; and the 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.
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