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Plus Therapeutics Expands ReSPECT™ Clinical Trial to MD Anderson Cancer Center

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Plus Therapeutics (PSTV) has announced that the University of Texas MD Anderson Cancer Center is now an active clinical trial site for its ReSPECT™ Phase 1 clinical trial. This trial investigates the company's lead candidate, Rhenium NanoLiposome (RNL™), in patients with recurrent glioblastoma (GBM). The trial is supported by the National Cancer Institute. The sixth dose escalation cohort is currently underway, with enrollment expected to complete by the end of 2020. RNL has also received Orphan Drug and Fast Track designations from the FDA for glioblastoma treatment.

Positive
  • MD Anderson Cancer Center joins ReSPECT clinical trial as a new site.
  • Progress reported with the sixth dose escalation cohort underway.
  • RNL received Orphan Drug and Fast Track designations from the FDA.
Negative
  • None.

AUSTIN, Texas., Dec. 01, 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 that the University of Texas MD Anderson Cancer Center is now an active clinical trial site in its ongoing ReSPECT™ Phase 1 clinical trial, currently supported by the National Cancer Institute (NCI). ReSPECT is a multi-center, dose-finding study evaluating the Company’s lead investigational asset, Rhenium NanoLiposome (RNL™), in patients with recurrent glioblastoma (GBM).

The study will be conducted by MD Anderson’s Department of Neurosurgery with Jeffrey Weinberg, M.D., Professor of Neurosurgery and the Deputy Chair and Vice-Chair of Clinical Operations in The Department of Neurosurgery, as primary investigator.

“We are very excited to now have the MD Anderson Cancer Center enrolling patients in the ReSPECT clinical trial,” said Andrew J. Brenner, M.D., Ph.D., Associate Professor of Medicine, Neurology, and Neurosurgery at The University of Texas, Health Services Center at San Antonio and principle investigator of the ReSPECT trial. “Jeffrey and his team are a valuable addition to our efforts to advance RNL as a potential new treatment option for recurrent GBM.”

“We are pleased to add Dr Weinberg and the MD Anderson Cancer Center team to our growing list of ReSPECT trial sites,” said Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. “The company will significantly benefit from the exceptional team of institutions as well as clinical and scientific advisors with whom we are working that all share our dedication to improving the care of GBM patients.”

As the Company previously disclosed, the sixth dose escalation cohort of the ReSPECT trial is underway and expected to enroll by the end of 2020. In September 2020, the U.S. Food and Drug Administration granted both Orphan Drug designation and Fast Track designation to RNL for the treatment of patients with glioblastoma. 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 ReSPECT clinical trial about?

The ReSPECT trial is a Phase 1 clinical study evaluating Rhenium NanoLiposome (RNL™) for patients with recurrent glioblastoma (GBM).

Who is leading the ReSPECT trial at MD Anderson?

The trial is led by Dr. Jeffrey Weinberg, Professor of Neurosurgery at MD Anderson Cancer Center.

What designations did RNL receive from the FDA?

Rhenium NanoLiposome (RNL) received both Orphan Drug designation and Fast Track designation for glioblastoma treatment.

What is the expected enrollment completion date for the sixth dose cohort?

Enrollment for the sixth dose escalation cohort is expected to complete by the end of 2020.

Which institution is involved in the ReSPECT trial?

The University of Texas MD Anderson Cancer Center is the latest institution added to the ReSPECT trial.

PLUS THERAPEUTICS, Inc.

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