Plus Therapeutics, Inc. receives FDA Orphan Drug Designation for its Novel Glioblastoma Treatment
September 01 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 orphan drug designation for its lead
investigational drug, Rhenium NanoLiposomes (RNL™) for the
treatment of patients with recurrent glioblastoma.
RNL is being evaluated in the NIH/NCI-supported, multi-center
ReSPECT™ Phase 1 dose-finding clinical trial (NCT01906385).
Last week, the trials’ Data Safety and Monitoring Board approved
the Company to proceed to Cohort 6 which includes increasing both
the drug volume and radiation dose to 8.8 milliliters (mL) and 22.3
millicuries (mCi), respectively.
“Receiving FDA orphan drug designation and approval to advance
the trial into Cohort 6 are key milestones in our development of
this treatment for recurrent glioblastoma,” said Dr. Marc Hedrick,
President and Chief Executive Officer of Plus Therapeutics. “We
believe RNL has the potential to prolong survival for patients with
malignant brain tumors and that of other difficult to treat
radiosensitive tumors.”
RNL is designed to safely, effectively, and conveniently deliver
a very high dose of radiation - up to 25 times greater
concentration than currently used external beam radiation therapy -
directly into the brain tumor for maximum effect.
The FDA’s Office of Orphan Drug Products grants orphan status to
support development of medicines for underserved patient
populations, or rare disorders, that affect fewer than 200,000
people in the U.S. Orphan drug designation provides to the
Company certain benefits, including market exclusivity upon
regulatory approval, exemption of FDA application fees, and tax
credits for qualified clinical trials.
Glioblastoma (Grade IV astrocytoma) is the most common and most
aggressive of the primary malignant brain tumors in adults.
According to the most recent CBTRUS Statistical Report, annually
there are approximately 11,833 cases of glioblastoma diagnosed
within 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.
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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