Plus Therapeutics Completes Sixth Dosing Cohort in ReSPECT™ Glioblastoma Trial
December 15 2020 - 7:30AM
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.
Investor ContactPeter VozzoWestwicke/ICR(443) 377-4767
Peter.Vozzo@westwicke.com
Media ContactTerri ClevengerWestwicke/ICR(203)
856-4326Terri.Clevenger@westwicke.com
Plus Therapeutics (NASDAQ:PSTV)
Historical Stock Chart
From Aug 2024 to Sep 2024
Plus Therapeutics (NASDAQ:PSTV)
Historical Stock Chart
From Sep 2023 to Sep 2024