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 positive new interim data from its ongoing ReSPECT™
Phase 1 clinical trial evaluating the Company’s lead
investigational asset, Rhenium NanoLiposome (RNL™), in patients
with recurrent glioblastoma (GBM). These results were presented in
an electronic poster entitled, “Safety and Feasibility of
Rhenium-186 Nanoliposomes (RNL™) in Recurrent GBM: the ReSPECT
Phase 1 Trial,” at the 2020 Society for Neuro-Oncology (SNO) Annual
Meeting, which is taking place virtually November 19-21, 2020.
The interim data set shows that intratumoral RNL
can successfully deliver up to fifteen times the absorbed dose of
radiation administered by standard external beam radiation therapy
(EBRT) without significant toxicity. These data support progression
to the ReSPECT trial’s sixth dose escalation cohort.
“The results we have seen thus far from ReSPECT
are encouraging and support the continued development of RNL as a
potential new option for recurrent GBM patients,” said Andrew J.
Brenner, M.D., Ph.D., Associate Professor of Medicine, Neurology,
and Neurosurgery at The University of Texas, Health Services Center
at San Antonio and principle investigator of the study. “With
limited therapeutic options for these patients, we remain committed
to advancing this clinical program to further investigate the
therapeutic potential of RNL.”
“Treatment for glioblastoma remains a
significant challenge as current therapies have exhibited limited
efficacy,” stated Marc Hedrick, M.D., President and Chief Executive
Officer of Plus Therapeutics. “RNL’s novel design allows the drug
to be targeted directly into the tumor using a small catheter and
enabling greater control of radiation dosing. These encouraging
data reinforce RNL’s potential to deliver targeted high-dose
radiation in a safe, effective, and convenient manner.”
Key
Results from the
Interim
Analysis
- All 15 patients
in the first five of six planned cohorts have completed
treatment.
- RNL treatment
volume and radiation dose increased successfully from 0.66
milliliter (mL) to 8.8 mL and 1.0 millicurie (mCi) to 22.3 mCi,
respectively.
- Cohort 5
patients received an RNL average absorbed radiation dose of 423
Gray (Gy).
- RNL has been
well-tolerated, and no dose-limiting toxicity has been observed
despite markedly higher absorbed doses of radiation compared to
EBRT.
- Most adverse
events (AEs) were considered causally unrelated to RNL except scalp
discomfort, which was considered related to the surgical procedure.
Neither the incidence nor severity of AEs appeared to increase with
increasing doses of RNL.
- Four serious
adverse events (SAEs) were reported, none of the SAEs were
considered causally related to RNL.
- Median survival
duration in patients that previously received bevacizumab (n=7) was
4.8 months, while median and mean survival durations in patients
that were bevacizumab-naïve (n=8) are currently 11.0 months (range
3.5 – 33) and 15.4 months (95% CI 7.4 – 23.4), respectively, with
four patients still alive.
- Two patients
survived greater than 30 months after therapy with RNL.
The sixth dose escalation cohort of the ReSPECT
trial is underway and one patient has thus far been treated. The
sixth cohort is expected to fully enroll by the end of 2020. In
September 2020, the U.S. Food and Drug Administration (FDA) granted
both Orphan Drug designation and Fast Track designation to RNL for
the treatment of patients with glioblastoma. Additional details
about the ReSPECT trial are available at clinicaltrials.gov
(NCT01906385).
Webinar details
The Company will host a webinar today, Thursday,
November 19, 2020, 4:30 to 5:30 p.m. ET discussing these data.
Andrew J. Brenner, M.D., Ph.D., Associate Professor of Medicine,
Neurology, and Neurosurgery at The University of Texas, Health
Services Center at San Antonio, will provide an update on the
ReSPECT trial and provide insight on the trial data. In addition, a
patient with recurrent GBM from the ReSPECT trial will provide
their treatment experience with RNL.
Marc Hedrick, M.D., President and Chief
Executive Officer of Plus Therapeutics, and Gregory D. Stein, M.D.,
M.B.A., Senior Vice President, Clinical Development of Plus
Therapeutics, will discuss the technology behind RNL as well as the
current treatment landscape and unmet medical need in treating
patients with recurrent GBM.
The live webinar with accompanying slides will
be available in the Events page of the ‘Investors’ section of the
Plus Therapeutics website or by clicking here. Individuals can
participate in an interactive Q&A session by submitting
pertinent questions via the webcast platform.
Please log in approximately 10 minutes prior to
the scheduled start time. The archived webcast will be available in
the Events section of the Company's website for 90 days.
A live audio conference will be available by
dialing (833) 340-0285 (toll-free) or (236) 712-2475 and entering
Conference ID 6095968.
Andrew J. Brenner, M.D.,
Ph.D.
Dr. Brenner is a nationally known expert in the
treatment of brain and breast cancers, with a particular research
interest in developing new treatments. He has served on multiple
committees and panels including for the National Institutes of
Health, National Cancer Institute, Department of Defense Breast
Cancer Research Program, and others. He has also served on advisory
committees for a number of companies to help direct development of
new drugs. His laboratory work developing new treatments has been
funded by the Food and Drug Administration, National Cancer
Institute, and Cancer Prevention and Research Institute of Texas.
He has published nearly 50 original research articles in peer
reviewed journals. Dr. Brenner is a member of the Plus Therapeutics
Scientific Advisory Board.
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
A video accompanying this announcement is available
at https://www.globenewswire.com/NewsRoom/AttachmentNg/5639e2df-2399-4963-8796-f86e100ffa8e
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