Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a
clinical-stage pharmaceutical company developing targeted
radiotherapeutics with advanced platform technologies for central
nervous system cancers, today reported positive data from the
ReSPECT-LM clinical study evaluating the Company’s lead
radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of
leptomeningeal metastases (LM) at the Society for Neuro Oncology
(SNO)/American Society of Clinical Oncology (ASCO) Central Nervous
System (CNS) Cancer Conference taking place August 10-12, 2023 in
San Francisco, California.
“We are very encouraged by the initial safety
and survival data in the ReSPECT-LM clinical trial following a
single administration of a relatively low dose of rhenium (186Re)
obisbemeda,” said Andrew J. Brenner, M.D., Ph.D., Professor of
Medicine, Neurology, and Neurosurgery at The University of Texas
Health Science Center at San Antonio and principal investigator of
the ReSPECT-LM clinical trial. “Based on the Phase 1 Part A data,
we believe we can substantially dose escalate and develop a
multiple dosing regimen that could yield meaningful clinical
benefits including a survival benefit for the extremely tough
clinical problem of leptomeningeal metastases.”
“Our principal corporate goal is to dramatically
improve the health and length of life of patients that have the
most lethal CNS cancers,” said Marc H. Hedrick, M.D., M.B.A.,
President and Chief Executive Officer of Plus Therapeutics.
“Similar to our promising Phase 1 and 2 data for glioblastoma, this
most recent data indicates that LM, which is ten times more
common than glioblastoma, may be similarly addressable with
targeted radiotherapy using rhenium (186Re) obisbemeda.”
The poster presentation is titled,
Preliminary Clinical Data in the Phase 1/2a Dose Escalation
Trial of Rhenium (186Re)
Obisbemeda (186RNL) in
Leptomeningeal Metastases (LM): The ReSPECT-LM Trial
[LMAP-21].
Findings in Brief:
- Feasibility: Ten
treated patients received a single escalating dose (6.6-26.4 mCi by
intraventricular catheter or Ommaya reservoir) of rhenium (186Re)
obisbemeda, which circulated throughout the cerebrospinal fluid
(CSF) space within minutes following administration and had
durable CSF retention for at least 7 days.
- Safety: No dose
limiting toxicities were observed and a maximum tolerated dose or
maximum feasible dose was not reached. Most adverse
events were mild (Grade 1, 58.7%) or moderate (Grade 2, 24%),
with the majority not related to treatment.
- Survival:
Currently, 5 of the 10 treated patients remain alive with a median
overall survival (OS) of 10 months.
- Next Steps: U.S.
Food and Drug Administration (FDA) has approved continued dose
escalation.
Additional Findings:
- CSF tumor cell counts decreased
from pre-dose levels 28 days after treatment by up to 91%
(mean decrease = 53%).
- Increases in administered dose
correlated with linear increases in absorbed dose to the
target tissue.
- Non-CNS organ dosimetry
analysis of rhenium (186Re) obisbemeda confirmed these
radiation levels were low, with the spleen, liver, and bladder
having the most prominent rhenium (186Re) obisbemeda clearance, but
still significantly below critical organ toxicity levels.
The ReSPECT-LM clinical trial is funded, in part, by a 3-year,
$17.6 million grant by the Cancer Prevention & Research
Institute of Texas.
Key Opinion Leader Roundtable on Data
Presented at the 2023 SNO/ASCO CNS Cancer Conference - Webcast
Details
A key opinion leader roundtable discussion will
be held on Friday, August 11, 2023, at 8:00 a.m. ET to discuss the
data from the ReSPECT-LM clinical trial of rhenium (186Re)
obisbemeda presented at the SNO/ASCO CNS Cancer Conference. The
webinar will feature a comprehensive discussion about the ongoing
ReSPECT-LM Phase 1/2a dose escalation clinical trial, including key
safety, tolerability, dosing, feasibility, and efficacy data.
A webinar with accompanying slides will be
available in the Events page of the Investor Relations section of
the Plus Therapeutics website beginning Friday, August 11, 2023 at
8:00 a.m. ET. The webcast will be available on the Company’s
website for 90 days following the live call.
Copies of the presentations will be made
available under the Presentations tab of the Investors section of
the Company’s website following the meeting at
https://ir.plustherapeutics.com.
About Rhenium (186Re)
ObisbemedaRhenium (186Re) obisbemeda is a novel injectable
radiotherapy specifically formulated to directly deliver targeted
high-dose radiation in CNS tumors in a safe, effective, and
convenient administration. Rhenium (186Re) obisbemeda has the
potential to reduce risks and improve outcomes for CNS cancer
patients, versus currently approved therapies, with a more targeted
and potent radiation dose. Rhenium-186 is an ideal radioisotope for
CNS therapeutic applications due to its short half-life, beta
energy for destroying cancerous tissue, and gamma energy for
real-time imaging. Rhenium (186Re) obisbemeda is being evaluated
for the treatment of recurrent glioblastoma and leptomeningeal
metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials.
ReSPECT-GBM is supported by an award from the National Cancer
Institute (NCI), part of the U.S. National Institutes of Health
(NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the
Cancer Prevention & Research Institute of Texas (CPRIT).
About Plus TherapeuticsPlus
Therapeutics, Inc. is a clinical-stage pharmaceutical company
developing targeted radiotherapeutics for difficult-to-treat
cancers of the central nervous system with the potential to enhance
clinical outcomes for patients. Combining image-guided local beta
radiation and targeted drug delivery approaches, the Company is
advancing a pipeline of product candidates with lead programs in
recurrent glioblastoma (GBM) and leptomeningeal metastases (LM).
The Company has built a robust supply chain through strategic
partnerships that enable the development, manufacturing, and future
potential commercialization of its products. Plus Therapeutics is
led by an experienced and dedicated leadership team and has
operations in key cancer clinical development hubs including Austin
and San Antonio, Texas. For more information, visit
https://plustherapeutics.com/.
Cautionary Statement Regarding
Forward-Looking StatementsThis 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 186Re including the ability of 186Re 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-GBM and
ReSPECT-LM clinical trials; possible negative effects of 186Re; the
continued evaluation of 186Re including through evaluations in
additional patient cohorts; 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 cancer diagnostics and
therapeutics 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 ContactPeter VozzoICR Westwicke(443)
377-4767Peter.Vozzo@westwicke.com
Media ContactTerri ClevengerICR Westwicke(203)
856-4326Terri.Clevenger@westwicke.com
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