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
AUSTIN, Texas, Sept. 01, 2020 (GLOBE NEWSWIRE) -- 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.com
Clinical Website: respect-trials.com
