Plus Therapeutics Receives Fast Track Designation From FDA for Its Novel Glioblastoma Treatment
September 15 2020 - 7:00AM
Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), today
announced that the U.S. Food and Drug Administration (FDA) has
granted the Company Fast Track designation for its lead
investigational drug, Rhenium NanoLiposomes (RNL™), for the
treatment of patients with recurrent glioblastoma. As previously
reported, the Company also received orphan drug designation from
the FDA for RNL for the treatment of patients with
glioblastoma.
Fast Track designation confers several benefits
to the drug development program including 1) more frequent meetings
with FDA to discuss the drug's development plan, 2) more frequent
written communication from FDA about such things as the design of
the proposed clinical trials and use of biomarkers, 3) eligibility
for Accelerated Approval and Priority Review, if relevant criteria
are met, and 4) Rolling Review, which means that a drug company can
submit completed sections of its New Drug Application (NDA) for
review by FDA, rather than waiting until every section of the NDA
is completed before the entire application can be reviewed. NDA
review usually does not begin until the drug company has submitted
the entire application to the FDA.
“Fast Track designation validates the potential
importance of this novel radiotherapeutic for patients with
recurrent glioblastoma who currently have no good treatment
options,” said Dr. Marc Hedrick, President and Chief Executive
Officer of Plus Therapeutics. “With this designation in hand, we
intend to move into Cohort 6 of the trial, one key step closer to
bringing forth a novel therapy for these patients.”
RNL is being evaluated in the NIH/NCI-supported,
multi-center ReSPECT™ Phase 1 dose-finding clinical trial
(NCT01906385) As reported last week, the ReSPECT trials’ Data
and Safety Monitoring Board (DSMB) approved the Company to proceed
to Cohort 6 of the trial, which includes increasing both the drug
volume and radiation dose to 8.8 milliliters (mL) and 22.3
millicuries (mCi), respectively.
RNL is designed to safely, effectively, and
conveniently deliver a very high dose of radiation, of up to 25
times greater concentration than currently used external beam
radiation therapy, directly into the brain tumor for maximum
effect.
About Glioblastoma
Glioblastoma (Grade IV astrocytoma) is the most
common and most aggressive of the primary malignant brain tumors in
adults. According to the most recent Central Brain Tumor Registry
of the United States (CBTRUS) Statistical Report, on average there
are nearly 12,0000 cases of glioblastoma diagnosed annually in the
U.S., with historical 1-year and 5-year median survival rates of
40.8% and 6.8%, respectively.
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 Vozzo Westwicke/ICR(443)
377-4767 Peter.Vozzo@westwicke.com
Media ContactTerri ClevengerWestwicke/ICR(203)
856-4326Terri.Clevenger@westwicke.com
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