Plus Therapeutics Announces Initiation of Final Cohort of ReSPECT™ Glioblastoma Trial
October 29 2020 - 7:00AM
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 ContactPeter VozzoWestwicke/ICR(443)
377-4767 Peter.Vozzo@westwicke.com
Media ContactTerri ClevengerWestwicke/ICR(203)
856-4326Terri.Clevenger@westwicke.com
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