AUSTIN, Texas, Aug. 13, 2022 (GLOBE NEWSWIRE) — Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing innovative, targeted radiation therapies for rare and difficult-to-treat diseases cancers, yesterday presented positive data from two ongoing clinical trials of its lead investigational drug, Rhenium-186 Nanoliposome (186RNL), in the treatment of recurrent glioblastoma (GBM) and leptomeningeal metastases (LM) at the 2022 Annual Conference on Clinical Trials in CNS and Brain Metastases. The conference is co-sponsored by the Society for Neuro-Oncology (SNO) and the American Society of Clinical Oncology (ASCO) and will be held August 12-13, 2022 in Toronto, Canada.
The oral presentation, entitled Safety and Feasibility of Rhenium-186 Nanoliposome (186RNL) in the Phase 1/2a Dose Escalation Trial in Leptomeningeal Metastases [LOCL-04]demonstrated that the 186The dose of RNL administered via an intraventricular catheter at 6.6 mCi in 5.0 mL achieved absorbed doses of 18.7 to 29.0 Gy in the ventricles and cranial subarachnoid space, which was well tolerated with no treatment-related adverse events greater than Grade 1. In addition, all three patients in the cohort were observed to have prompt and complete treatment 186RNL distribution throughout the subarachnoid space of cerebrospinal fluid (CSF) that was durable beyond one week and very well tolerated. Importantly, all patients showed a decrease in CSF cell counts by microfluidic chamber assay after treatment, ranging from 65% to 92%, which was also durable.
“Although we can only draw limited conclusions from the first cohort of patients, these results suggest that the application of locally administered and highly targeted 186RNL for the treatment of ML has the potential to be an effective and safe treatment for patients. patients,” said Norman LaFrance, MD, chief medical officer and SVP at Plus Therapeutics.
“Leptomeningeal metastases are a devastating complication of cancer that often forces patients to choose between toxic therapies or a limited life expectancy that adds to the already complex burden of their underlying cancer. However, our approach to delivering 186RNL is precisely targeted to the CNS and minimizes radiation exposure to other parts of the body and most importantly has the potential to prolong patient survival,” said Andrew J. Brenner, MD, Ph.D., Professor of Medicine , of neurology and neurosurgery at the University of Texas Health Sciences Center at San Antonio and principal investigator of the ReSPECT-LM clinical trial. “We look forward to continuing clinical evaluation with additional dose increases to further evaluate 186The versatility of RNL and on behalf of patients in need.
Dr. Brenner also presented a poster titled, Safety and Feasibility of Rhenium-186 Nanoliposome (186RNL) in recurrent glioma: the ReSPECT™ phase 1 trial [LOCL-08]which demonstrated that in 23 subjects with recurrent GBM receiving a single administration of 186RNL, significant overall survival benefits were seen in those achieving an average absorbed radiation dose greater than 100 Gy to the tumor compared to those with less absorption. These results suggest a correlation between increasing convected drug volume and radiation dose with improved overall patient survival and to date, 80% of patients in Cohorts 5-7 have reached threshold levels. high absorption above 100 Gy.
Data exposure 186RNL treatment is safe and well tolerated, with no adverse events (AEs) resulting in death or discontinuation of treatment. At the time of presentation, four patients are still alive. Cohort 7 of the trial, with an increased dose of 186RNL (31.2 mCi and 12.3 mL infusion volume) is being recruited.
“Taken together, this data from ReSPECT-LM and ReSPECT-GBM represents Plus’ continued dedication to evaluating 186RNL in the clinical setting and the encouraging results showing that our product is safe and effective in treating these difficult-to-treat cancers,” said Marc Hedrick, MD, President and CEO of Plus Therapeutics. “As we look to the remainder of 2022, we remain focused on completing key manufacturing, clinical and regulatory milestones that will support the continued development and validation of 186RNL so that we can quickly bring our therapy to patients.
A copy of the poster and presentation will also be available under the Presentations tab of the Investors section of the Company’s website at https://ir.plustherapeutics.com.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on developing, manufacturing and marketing complex and innovative treatments for patients battling cancer and other life-threatening diseases. Our proprietary nanotechnology platform is currently focused on improving delivery of a variety of drugs using novel liposomal encapsulation technology. Liposomal encapsulation has been widely explored and has been the subject of significant technical and commercial advances since its development. Our platform is designed to facilitate new delivery approaches and/or formulations of safe and effective injectable drugs, potentially improving safety, efficacy and convenience for patients and healthcare providers. More information can be found at PlusTherapeutics.com and ReSPECT-Trials.com.
Caution Regarding Forward-Looking Statements
This press release contains statements that may be considered “forward-looking statements” within the meaning of United States securities laws. All statements in this press release other than statements of historical facts are forward-looking statements. These forward-looking statements can be identified by future verbs, as well as terms such as “designed for”, “will”, “may”, “potential”, “focus”, “prepare”, “next steps”, “possibly”, and similar expressions or their negative forms. These statements are based on 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 deem appropriate. These statements include, but are not limited to, statements regarding the following: the potential promise of 186RNL, including the ability to 186RNL to safely and effectively deliver radiation directly to the tumor at high doses; expectations regarding the future performance of the Company, including next steps in the development of the Company’s current assets; the Company’s clinical trials, including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186RNL; ongoing evaluation of 186RNL, including through assessments in additional patient cohorts; and the intended functions of the Company’s platform and the expected benefits of such functions.
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