Plus Therapeutics Announces Initiation of Final Cohort of ReSPECT™ Glioblastoma Trial

Rhea-AI Summary

Plus Therapeutics announces the initiation of the sixth cohort in its NCI-supported ReSPECT™ Phase 1 clinical trial, targeting recurrent glioblastoma with Rhenium NanoLiposomes (RNL™). This progression follows a successful fifth cohort, backed by the Data and Safety Monitoring Board’s clearance. Cohort six will increase both the drug volume to 8.8 mL and radiation dose to 22.3 millicuries. This trial is part of Plus Therapeutics’ strategy to enhance treatment efficacy for glioblastoma, with interim data presentation scheduled for the 2020 SNO Annual Meeting in November.

Positive

• Successful progression to the sixth cohort of the ReSPECT trial, indicating progress in clinical evaluation.
• Increased RNL drug volume and radiation dose aims to improve treatment efficacy for glioblastoma.

Negative

• None.

Data and Safety Monitoring Board evaluated safety data in recommending cohort progression

AUSTIN, Texas, Oct. 29, 2020 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), today announced that it has treated the first patient in the sixth and final cohort of its National Cancer Institute (NCI)-supported, multi-center ReSPECT™ Phase 1 dose-finding clinical trial evaluating Rhenium NanoLiposomes (RNL™) for the treatment of recurrent glioblastoma (GBM). Initiation of the sixth dose cohort follows successful completion of the fifth cohort and clearance from the ReSPECT trial’s Data and Safety Monitoring Board (DSMB).

The sixth cohort of the ReSPECT trial includes an increase in both the RNL drug volume and 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, with a dose that is up to 25 times greater than currently used external beam radiation therapy, directly into the brain tumor for maximum effect.

“Cohort progression in our ReSPECT trial represents another milestone toward the trial’s first major readout,” said Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. “The RNL drug volume and dose in cohort six should allow us to target the majority of glioblastoma tumors found in the recurrent setting.”

Plus Therapeutics will be presenting data from the ReSPECT clinical trial at the 2020 Society for Neuro-Oncology (SNO) Annual Meeting being held virtually November 19-21, 2020. The Company will be providing detailed interim safety, tolerability, dosing and efficacy data of RNL in adults with recurrent GBM after standard surgical, radiation and chemotherapy treatment.

ReSPECT is currently supported by an award from the NCI. The Company plans to complete enrollment in the Phase 1 trial by the end of 2020 and in parallel will utilize its recently awarded U.S. Food and Drug Administration Orphan Drug and Fast Track designations to determine the next steps for the program.

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 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.

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

FAQ

What is the significance of the sixth cohort in Plus Therapeutics' ReSPECT trial?

The sixth cohort represents a milestone in evaluating Rhenium NanoLiposomes for treating recurrent glioblastoma, with increased dosage aimed at enhancing treatment effectiveness.

When will Plus Therapeutics present data from the ReSPECT trial?

Plus Therapeutics will present interim safety and efficacy data from the ReSPECT trial at the Society for Neuro-Oncology Annual Meeting from November 19-21, 2020.

What are the new drug volume and radiation doses in the sixth cohort of the ReSPECT trial?

In the sixth cohort, the Rhenium NanoLiposomes drug volume has been increased to 8.8 milliliters and the radiation dose to 22.3 millicuries.

What is the status of Plus Therapeutics' ReSPECT trial as of October 2020?

As of October 2020, the ReSPECT trial is progressing after the successful completion of the fifth cohort, with plans to complete enrollment by the end of the year.