Plus Therapeutics Reports Positive Interim Updates from Two ReSPECT™ Clinical Trials at SNMMI Annual Meeting
29 Giugno 2023 - 1:00PM
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 interim updates
from the ReSPECT-GBM and ReSPECT-LM clinical studies evaluating the
Company’s lead radiotherapeutic, rhenium (186Re) obisbemeda, for
the treatment of recurrent glioblastoma (rGBM) and leptomeningeal
metastases (LM) at the Society of Nuclear Medicine & Molecular
Imaging (SNMMI) Annual Meeting, which took place June 24-27, 2023
in Chicago, Illinois.
An oral presentation titled, Safety and
Feasibility Results from a Phase 1/2 Clinical Trial of 186RNL
(Rhenium-186 Nanoliposome) (186Re) Obisbemeda in Recurrent Glioma:
The ReSPECT-GBM Trial [P988], brief highlights
include:
- Data from 21 patients in the Phase
1 trial used to support the recommended Phase 2 trial dose for
patients with tumor volumes ≤20 mL was presented.
- A single dose of
rhenium (186Re) obisbemeda was generally safe and well-tolerated,
with no dose-limiting toxicities and minimal systemic radiation
exposure.
- The data
demonstrates efficacy signals in a prognostically unfavorable
patient population.
- The median
overall survival (OS) in all 21 patients (including those receiving
small radiation doses in early cohorts and five patients previously
treated with Bevucizamab) was 11 months or a 38% increase in OS
versus a median OS of approximately 8 months for standard of care
in rGBM.
- Median OS in
patients receiving >100 Gy of absorbed radiation dose was 76
weeks (17 months) versus 22 weeks (6 months) for those receiving
<100 Gy (p=0.0002).
- Increased
absorbed radiation dose and percent tumor volume treated correlates
with improvement in overall survival, specifically:
- For each 100 Gy
increase of Total Dose in Distribution Volume, the risk of death
decreases by 45.6% (p=0.003).
- For each 10%
increase in the Ratio of Treated to Total Tumor Volume, the risk of
death decreases by 66.9% (p=0.002).
A poster presentation titled,
Preliminary Clinical Data in The Phase 1/2a Dose Escalation
Trial of 186RNL (Rhenium-186 Nanoliposome) (186Re) Obisbemeda in
Leptomeningeal Metastases (LM): The ReSPECT-LM Trial
[P978], includes data that showed:
- Interim results
from 10 patients in the Phase 1 trial show a single treatment with
rhenium (186Re) obisbemeda decreased cerebrospinal fluid (CSF)
tumor cell count and was well-tolerated in patients with LM.
- Rhenium (186Re)
obisbemeda doses administered through an intraventricular catheter
(Ommaya reservoir) showed prompt, complete and durable distribution
throughout the CSF through Day 7.
- A single rhenium
(186Re) obisbemeda administered dose between 6.6 mCi and 26.4 mCi
achieved absorbed doses of up to 88.98 Gy to the ventricles and
cranial subarachnoid space.
- No dose limiting
toxicities were observed and safety observations were generally
minor and resolved.
- Phase 1/Part B,
for continued dose escalation (Cohorts 4-7), will open following
review by the U.S. Food and Drug Administration, and repeated
dosing will be explored. An expansion in Cohort 3 is currently
enrolling eligible patients.
- A full update
will be provided at the SNO/ASCO CNS Cancer Conference in August
10-12, 2023.
“Our Phase 1 ReSPECT-GBM trial has shown
feasibility, safety and a strong correlation between both absorbed
tumor radiation dose and tumor coverage,” said Norman LaFrance,
M.D., Chief Medical Officer of Plus Therapeutics. “As Phase 1
trials are designed for safety, statistically significant
correlations between dose and overall survival are unusual. We are
currently on track to complete the Phase 2 trial in late 2024 while
we continue to extend the open Phase 1 dose escalation trial, which
is now enrolling patients at approximately twice the radiation dose
of the current Phase 2, without dose limiting toxicities observed
thus far.”
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)
obisbemeda Rhenium (186Re) obisbemeda is a novel
injectable radiotherapy specifically formulated to deliver highly
targeted high dose radiation in CNS tumors in a safe, effective and
convenient manner to optimize patient outcomes. 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 live 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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