Plus Therapeutics Announces Topline Results from Recurrent Glioblastoma External Control Analysis at ASCO 2023
2023年5月30日 - 8:00PM
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 announced that a new analysis from
its partner Medidata, a Dassault Systèmes company, was accepted for
online publication at the 2023 American Society of Clinical
Oncology (ASCO) Annual Meeting, taking place June 2-6, in Chicago,
Illinois.
The abstract titled, “Clinical characterization
of patients with recurrent glioblastoma in trials involving CED and
non-CED treatment [#417610],” included data sourced from Medidata’s
more than 30,000 clinical trials involving more than nine million
de-identified participants. Aggregate summary statistics comparing
bevacizumab and convection-enhanced delivery (CED) patients were
based on combined study-level and patient-level data using sample
size weighted means, incidence and overall survival.
A total of 799 patients were evaluated from MEDS
and studies referenced in D’Amico [J Neurooncol 2021]. Both cohorts
(bevacizumab and CED, respectively) were comparable in terms of
median age (56 years vs. 55 years), Caucasian race (91% vs. 93%),
male sex (68% vs. 65%) and median overall survival (7.9 months vs.
8.4 months).
“The purpose of this analysis was to determine
whether bevacizumab patients could form an appropriate external
control for evaluating overall survival in current and upcoming CED
trials,” said Norman LaFrance, M.D., Chief Medical Officer of Plus
Therapeutics. “The results of this analysis provide confidence in
the use of an external control arm formed from aggregated clinical
trial data of patients previously treated with bevacizumab to
interpret the results of the ReSPECT-GBM Phase 1/2 trials. Thus
far, our clinical outcomes are promising compared to those using an
external control. In a potential future pivotal trial, the use of a
historical control arm will enable Plus Therapeutics to more
rapidly enroll the trial while simultaneously reducing trial
costs.”
In April 2022, the Company entered into an
expanded partnership with Medidata to utilize the Synthetic Control
Arm® platform in its Phase 2 trial for rGBM, in a manner that has
historically been favorably received by the U.S. Food and Drug
Administration.
About the Synthetic Control
Arm®Medidata’s Synthetic Control Arm (SCA) – a type of
external control – is formed by carefully selecting patients from
Medidata’s extensive repository of historical clinical trials to
match the baseline demographic and disease characteristics of the
patients treated with the new investigational product. Case studies
have shown that SCAs can effectively mimic a classic randomized
control and, therefore, can be used to accurately interpret the
treatment effects of an investigational product.
SCAs can help enhance the scientific validity of
single-arm trials and, in certain indications, enhance randomized
clinical trials to expose fewer prospective patients to control
and/or ineffective or existing standard-of-care treatments that
might not provide a benefit to the patient. This is done while
still providing highly valid scientific evidence. These factors can
influence a patient’s willingness to participate in a trial where
there is a very poor prognosis and perceived inadequate standard of
care.
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
Plus Therapeutics (NASDAQ:PSTV)
過去 株価チャート
から 4 2024 まで 5 2024
Plus Therapeutics (NASDAQ:PSTV)
過去 株価チャート
から 5 2023 まで 5 2024