Plus Successfully Treats First Patient in Latest Dosing Cohort in ReSPECT™-GBM Trial
Plus Therapeutics, Inc. (PSTV) announced the successful treatment of the first patient in the eighth cohort of their Phase 1 ReSPECT™-GBM clinical trial for recurrent glioblastoma. This cohort features a 40% increase in treatment volume and radioactivity compared to previous cohorts. To date, 22 patients have been treated across eight cohorts with no dose-limiting toxicities reported. The trial is progressing as scheduled, and an update is expected in Q4 2021.
- First patient successfully treated in the eighth cohort of ReSPECT™-GBM clinical trial.
- 40% increase in treatment volume and radioactivity in the current cohort.
- No treatment emergent dose-limiting toxicities reported so far.
- None.
Recurrent Glioblastoma Trial Update Planned for Q4 2021
AUSTIN, Texas, July 22, 2021 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, today announced the first patient in the eighth cohort of the Phase 1 dose escalation ReSPECT™-GBM clinical trial for recurrent glioblastoma (rGBM) has been successfully treated. The present cohort implements a
“The ReSPECT™-GBM Phase 1 clinical trial is progressing on schedule and with an acceptable safety profile,” said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. “We plan to provide an update on the trial in the fourth quarter of 2021.”
Twenty-two patients across eight dosing cohorts have been treated in the ReSPECT™ trial to date. Thus far, no treatment emergent dose-limiting toxicities have been observed, despite absorbed radiation doses to the tumor of up to 740 Gray.
About Plus Therapeutics, Inc.
Plus Therapeutics 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 statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “will,” “believe,” “plan,” “can,” “enable,” “design,” “intend,” “potential,” “expect,” “estimate,” “project,” “prospect,” “target,” “focus,” “anticipate,” “could,” “should,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by 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 regarding the following: the Company’s anticipated expenditures, including research and development, sales and marketing, and general and administrative expenses; anticipated benefits of strategic collaborations and license agreements, intellectual property, FDA approval process and government regulation; the Company’s ability to benefit from the NIH/NCI award for continued clinical development of 186RNL for recurrent glioblastoma; the ability of 186RNL to safely and effectively deliver radiation directly to the tumor at high doses; the Company’s ability to expand clinical testing of 186RNL to additional sites; the potential size of the market for the Company’s product candidates; the Company’s research and development efforts; the Company’s IP strategy; competition; future development and/or expansion of its product candidates and therapies in its markets; the Company’s ability to generate product or development revenue and the sources of such revenue; the amounts that the Company may be obligated to pay under license agreements; the Company’s ability to effectively manage its gross profit margins; its ability to obtain and maintain regulatory approvals; expectations as to the Company’s future performance; the Company’s need for additional financing and the availability thereof; its ability to fully access its equity line with Lincoln Park; any changes to its interest expenses; the Company’s ability to continue as a going concern; its ability to remain listed on the Nasdaq Capital Market; the Company’s ability to repay or refinance some or all of its outstanding indebtedness and its ability to raise capital in the future; expectations as to the impact of recently issued or adopted accounting standards; the Company’s expectations as to the impact of the COVID-19 pandemic on its business and operating results; the Company’s beliefs as to the impact of any liability that may arise as a result of any legal proceedings; and the potential enhancement of the Company’s cash position through development, marketing, and licensing arrangements.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the regenerative medicine field, among others; and additional 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 Contact
Peter Vozzo
Westwicke/ICR
(443) 377-4767
Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
Westwicke/ICR
(203) 856-4326
Terri.Clevenger@westwicke.com
FAQ
What is the latest update on Plus Therapeutics' ReSPECT™-GBM trial?
When will Plus Therapeutics provide an update on the ReSPECT™-GBM trial?
How many patients have been treated in the ReSPECT™-GBM clinical trial?