Plus Therapeutics Reports Positive Clinical Outcomes from ReSPECT-GBM Trial at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2022 Annual Meeting

Rhea-AI Summary

Plus Therapeutics (PSTV) announced promising interim results from its Phase 1/2a ReSPECT-GBM trial for Rhenium-186 NanoLiposome (186RNL) in recurrent glioblastoma patients. The study showed that 186RNL, delivered via convection enhanced delivery, effectively targets tumors with minimal radiation exposure to healthy tissue. No significant adverse events were recorded during dose escalation, which involved 24 patients across seven cohorts. The company plans to initiate a Phase 2 trial by the end of 2022 and is also evaluating 186RNL for additional indications.

Positive

• 186RNL demonstrated effectiveness in targeting tumors with over 100 Gy doses while maintaining safety.
• No significant adverse events reported during the clinical trials.
• Plans to initiate a Phase 2 trial by the end of 2022, indicating progress in clinical development.

Negative

• None.

Data validates continued high radiation absorbed of ¹⁸⁶RNL in escalating doses to treat glioblastoma, maintaining safety and limiting brain and whole-body exposure

Company will also present at upcoming BIO International Convention 2022 being held June 13-16 in San Diego, California

AUSTIN, Texas, June 13, 2022 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, today announced it will present positive data on its lead investigational drug, Rhenium-186 NanoLiposome (¹⁸⁶RNL), from the Phase 1/2a ReSPECT™-GBM dose escalation clinical trial in patients with recurrent glioblastoma (GBM) during an oral presentation at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2022 Annual Meeting, on June 14 at 10:20 AM PT in Vancouver, British Columbia, Canada.

According to the interim data, ¹⁸⁶RNL delivered via convection enhanced delivery (CED) provides direct therapy with high radiation absorbed doses for local tumor control with minimal brain and whole-body radiation exposure. ¹⁸⁶RNL’s tumor-killing effects were observed when greater than 100 Gy doses are delivered to greater than 80% of a tumor without dose-limiting toxicity.

The presentation, titled “Rhenium-186-NanoLiposome (¹⁸⁶RNL) in the treatment of relapse/recurrent glioblastoma (rGBM): a novel approach to cancer therapy,” outlines data from the ReSPECT-GBM trial, substantially funded by the U.S. National Institutes of Health/National Cancer Institute, which has thus far evaluated 24 adult patients with recurrent GBM across seven cohorts of increasing dose. To date, there have been no significant adverse events during the dose escalation.

“¹⁸⁶RNL’s novel localized radio-nanotherapeutic approach has significant potential to translate into treatment for a broad range of tumors where local tumor control is difficult or all other therapies are exhausted, ineffective or toxic,” said William Phillips, M.D., Nuclear Medicine Physician at UT Health-San Antonio, and primary presenter. “To treat glioblastoma, the targeted and controlled use of ¹⁸⁶RNL is critical for patients as we aim to mitigate brain and whole-body exposure. The novel administration via localized radio-nanotherapeutic enables high doses of radiation to be absorbed while protecting patients from the harsh effects of unnecessary radiation exposure.”

The Company expects to initiate a Phase 2/registrational trial of ¹⁸⁶RNL in patients with recurrent GBM by the end of 2022. In addition, the Company is continuing to evaluate ¹⁸⁶RNL in leptomeningeal metastases as part of the ReSPECT-LM Phase 1/2a dose escalation clinical trial and is in late-stage planning for the treatment of pediatric ependymoma and high-grade GBM.

Upcoming Company Presentation at BIO International Convention

Additionally, Russ Havranek, Vice President of Corporate Strategy and New Product Planning of Plus Therapeutics will present a corporate update in person at the BIO International Convention 2022 on June 15 at 10:30 AM PT in San Diego, California.

Copies of both presentations will be made available under the Presentations tab of the For Investors section of the Company’s website following the meetings at www.plustherapeutics.com.

About Plus Therapeutics

Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on the development, manufacture, and commercialization of complex and innovative treatments for patients battling cancer and other life-threatening diseases.

Our proprietary nanotechnology platform is currently centered around the enhanced delivery of a variety of drugs using novel liposomal encapsulation technology. Liposomal encapsulation has been extensively explored and undergone significant technical and commercial advances since it was first developed. Our 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 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 “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” 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 potential promise of 186RNL including the ability of 186RNL to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-LM or the ReSPECT-PBC trials; possible negative effects of 186RNL; the continued evaluation of 186RNL including through evaluations via a seventh patient cohort; and the intended functions of the Company’s platform and expected benefits from such functions.

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 Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the regenerative medicine field, among others; 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
ICR Westwicke
(443) 377-4767
Peter.Vozzo@westwicke.com

Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
Terri.Clevenger@westwicke.com

FAQ

What are the results of Plus Therapeutics' (PSTV) ReSPECT-GBM trial?

The interim results show that Rhenium-186 NanoLiposome (186RNL) effectively targets recurrent glioblastoma with high doses of radiation and minimal exposure to healthy tissues.

When will Plus Therapeutics initiate its Phase 2 trial for 186RNL?

Plus Therapeutics plans to initiate the Phase 2 registrational trial for 186RNL by the end of 2022.

What is the aim of the ReSPECT-GBM clinical trial?

The ReSPECT-GBM trial aims to evaluate the safety and efficacy of 186RNL in delivering targeted radiation therapy to recurrent glioblastoma tumors.

What is the safety profile of 186RNL based on recent studies?

The trial reported no significant adverse events, highlighting the safety of 186RNL during dose escalation among patients.

Where and when is Plus Therapeutics presenting their findings?

Plus Therapeutics will present their findings at the Society of Nuclear Medicine and Molecular Imaging 2022 Annual Meeting on June 14 at 10:20 AM PT in Vancouver, Canada.