Plus Therapeutics Completes Fifth Dose Escalation Cohort of the ReSPECT™ Glioblastoma Clinical Trial and Expands Trial Sites

Rhea-AI Summary

Plus Therapeutics (Nasdaq: PSTV) announced the successful completion of the fifth cohort of the ReSPECT Clinical Trial, evaluating Rhenium NanoLiposomes (RNL™) in adults with recurrent glioblastoma (GBM). The trial has expanded to a second site at UT Southwestern Medical Center, enrolling 15 patients across five cohorts, with six more planned. RNL aims to deliver radiation doses up to 25 times greater than conventional methods, with further developments anticipated including cohort 6, completion of enrollment, and potential orphan drug designations.

Positive

• Successful completion of the fifth cohort in the ReSPECT Clinical Trial.
• Expansion of the trial to UT Southwestern Medical Center.
• Innovative treatment approach delivering radiation doses significantly higher than external beam radiation therapy.

Negative

• None.

AUSTIN, Texas, July 28, 2020 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”) today announced the successful completion of the fifth cohort of the ReSPECT Clinical Trial and expansion to a second clinical trial site, the UT Southwestern Medical Center in Dallas.

The Phase 1 ReSPECT Clinical Trial is intended to assess the safety, tolerability, and distribution of a novel radiotherapy, Rhenium NanoLiposomes (RNL™), in adults with recurrent glioblastoma (GBM) after standard surgical, radiation, and chemotherapy treatment. ReSPECT is supported by an award from the National Cancer Institute through Phase 2 development. Glioblastoma is a rare, incurable, and fatal disease with a median survival of about nine months following recurrence despite the current standard of care.

Patient screening and enrollment at UT Southwestern Medical Center is ongoing and will be led by principal investigator and neurosurgeon, Toral Patel, MD. “We are pleased to add the UT Southwestern Medical Center team led by Dr. Patel to our trial,” said Dr. Andrew Brenner, MD, PhD, who is the principal investigator of the trial and is the Kolitz Chair in Neuro-Oncology Research and Co-Leader of the Experimental and Developmental Therapeutics Program at UT Health San Antonio MD Anderson Cancer Center. “Convection-enhanced delivery of RNL directly into the tumor represents a promising new local radiation treatment option for recurrent GBM patients.” 

Plans are underway to expand ReSPECT to another site, the MD Anderson Cancer Center in Houston. To-date, the study has enrolled 15 patients across five cohorts at the UT Health Science Center San Antonio, with one more cohort of six patients planned to fully complete enrollment.

In ReSPECT, very high therapeutic doses of a high energy beta-emitting radioisotope, Rhenium-186, are precisely delivered directly into the brain tumor via stereotactic technology and convection-enhanced delivery (CED). Studies have demonstrated that CED holds great promise in terms of local drug penetration through the brain extracellular matrix/space. The local radiation delivered to the brain tumor with RNL is intended to be up to 25 times greater than that currently being given to patients using external beam radiation therapy (EBRT). Thus far, the highest absorbed radiation dose delivered to a patient’s tumor in ReSPECT is approximately 15 times the level typically delivered by EBRT.

The Company expects additional near-term ReSPECT and RNL developments to include:

• Continued dose escalation and expansion of delivery parameters through cohort 6.
• Completion of enrollment of the Phase 1 Trial.
• Determination of the recommended Phase 2 dose.
• Submission of applications for Orphan Disease Designation in the U.S. and Europe.
• Submission of an application for Fast Track Designation in the U.S.
• Data analysis and reporting of the ReSPECT Clinical Trial Results.
• Presentation by the Company for plans to expand RNL clinical development for multiple indications.

About Plus Therapeutics, Inc.

Plus Therapeutics (Nasdaq: PSTV) is a clinical-stage pharmaceutical company whose radiotherapeutic portfolio is concentrated on nanoliposome-encapsulated radionucleotides 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 www.plustherapeutics.com and www.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.

Contact:
Plus Therapeutics, Inc. 
Andrew Sims
VP – Chief Financial Officer, Investor Relations
Phone: +1.619.333.4150
Email: ir@plustherapeutics.com
Corporate Website: plustherapeutics.com
Clinical Website: respect-trials.com

FAQ

What is the purpose of the ReSPECT Clinical Trial for PSTV?

The ReSPECT Clinical Trial aims to assess the safety and tolerability of Rhenium NanoLiposomes (RNL™) in treating recurrent glioblastoma (GBM) after standard therapies.

How many patients have been enrolled in the PSTV ReSPECT trial?

Currently, 15 patients have been enrolled across five cohorts, with plans for additional cohorts.

What are the next steps for Plus Therapeutics regarding the ReSPECT trial?

Next steps include continuing dose escalation, completing enrollment, determining the recommended Phase 2 dose, and submitting for orphan disease designations.

What distinguishes Rhenium NanoLiposomes (RNL) from traditional therapies?

RNL aims to deliver radiation doses up to 25 times greater than those from conventional external beam radiation therapy, targeting the tumor more effectively.