Plus Therapeutics Completes Fifth Dose Escalation Cohort of the ReSPECT™ Glioblastoma Clinical Trial and Expands Trial Site...
July 28 2020 - 7:00AM
Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”) today
announced the successful completion of the fifth cohort of the
ReSPECT Clinical Trial and expansion to a second clinical trial
site, the UT Southwestern Medical Center in Dallas.
The Phase 1 ReSPECT Clinical Trial is intended
to assess the safety, tolerability, and distribution of a novel
radiotherapy, Rhenium NanoLiposomes (RNL™), in adults with
recurrent glioblastoma (GBM) after standard surgical, radiation,
and chemotherapy treatment. ReSPECT is supported by an award from
the National Cancer Institute through Phase 2 development.
Glioblastoma is a rare, incurable, and fatal disease with a median
survival of about nine months following recurrence despite the
current standard of care.
Patient screening and enrollment at UT
Southwestern Medical Center is ongoing and will be led by principal
investigator and neurosurgeon, Toral Patel, MD. “We are pleased to
add the UT Southwestern Medical Center team led by Dr. Patel to our
trial,” said Dr. Andrew Brenner, MD, PhD, who is the principal
investigator of the trial and is the Kolitz Chair in Neuro-Oncology
Research and Co-Leader of the Experimental and Developmental
Therapeutics Program at UT Health San Antonio MD Anderson Cancer
Center. “Convection-enhanced delivery of RNL directly into the
tumor represents a promising new local radiation treatment option
for recurrent GBM patients.”
Plans are underway to expand ReSPECT to another
site, the MD Anderson Cancer Center in Houston. To-date, the study
has enrolled 15 patients across five cohorts at the UT Health
Science Center San Antonio, with one more cohort of six patients
planned to fully complete enrollment.
In ReSPECT, very high therapeutic doses of a
high energy beta-emitting radioisotope, Rhenium-186, are precisely
delivered directly into the brain tumor via stereotactic technology
and convection-enhanced delivery (CED). Studies have demonstrated
that CED holds great promise in terms of local drug penetration
through the brain extracellular matrix/space. The local radiation
delivered to the brain tumor with RNL is intended to be up to 25
times greater than that currently being given to patients using
external beam radiation therapy (EBRT). Thus far, the highest
absorbed radiation dose delivered to a patient’s tumor in ReSPECT
is approximately 15 times the level typically delivered by
EBRT.
The Company expects additional near-term ReSPECT
and RNL developments to include:
- Continued dose escalation and expansion of delivery parameters
through cohort 6.
- Completion of enrollment of the Phase 1 Trial.
- Determination of the recommended Phase 2 dose.
- Submission of applications for Orphan Disease Designation in
the U.S. and Europe.
- Submission of an application for Fast Track Designation in the
U.S.
- Data analysis and reporting of the ReSPECT Clinical Trial
Results.
- Presentation by the Company for plans to expand RNL clinical
development for multiple indications.
About Plus Therapeutics,
Inc.
Plus Therapeutics (Nasdaq: PSTV) is a
clinical-stage pharmaceutical company whose radiotherapeutic
portfolio is concentrated on nanoliposome-encapsulated
radionucleotides 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 www.plustherapeutics.com and
www.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.
Contact:Plus
Therapeutics, Inc. Andrew Sims VP – Chief Financial
Officer, Investor Relations Phone: +1.619.333.4150
Email: ir@plustherapeutics.com Corporate
Website: plustherapeutics.comClinical
Website: respect-trials.com
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