AUSTIN, Texas - Plus Therapeutics, Inc. (NASDAQ:PSTV), a clinical-stage pharmaceutical company, announced results from its FORESEE study, demonstrating that its CNSide platform significantly influences clinical management decisions in leptomeningeal metastases (LM) cases.
The findings, presented at the recent Society for NeuroOncology/Clinical Oncology CNS Metastases Conference, showed CNSide's diagnostic sensitivity more than doubled compared to the gold standard CSF cytology.
The FORESEE trial, a prospective, multi-center observational study, enrolled 39 patients with breast or non-small cell lung cancer suspected or confirmed to have LM. The primary endpoint focused on how CNSide test results impacted clinical decision-making. The study's secondary endpoints included CNSide's diagnostic sensitivity versus CSF cytology and its role in personalizing treatment based on tumor molecular phenotype.
CNSide influenced treatment decisions in over 90% of cases, significantly exceeding the 20% primary endpoint target. It demonstrated an 80% sensitivity in detecting tumor cells compared to 29% with cytology. Moreover, CNSide identified actionable mutations in the CSF, such as HER2 amplification, which influenced therapeutic selection decisions in 24% of cases.
"CNSide is a more sensitive and definitive test for LM and has the potential to permit earlier diagnosis, manage our patients with more diagnostic precision, and hopefully improve therapeutic outcomes for our patients with LM," said Priya U. Kumthekar, M.D., the trial's principal investigator.
CNSide is a lab-developed test based on a proprietary method for quantitative tumor cell capture and detection, paired with assays for identifying actionable molecular treatment targets. It's designed for serial use to monitor therapy response more effectively than current methods.
LM is a rare cancer complication where the primary cancer spreads to the cerebrospinal fluid and leptomeninges. It's usually terminal, with patients often succumbing within weeks to months if untreated. CNSide is also being used in the ReSPECT-LM trial to quantify circulating tumor cells as an exploratory endpoint.
Plus Therapeutics is developing targeted radiotherapeutics for central nervous system cancers. Its pipeline includes product candidates for recurrent glioblastoma and LM, with a focus on enhancing clinical outcomes for patients.
The information in this article is based on a press release statement from Plus Therapeutics, Inc.
In other recent news, Plus Therapeutics has made significant strides in its clinical trials and financial standing. The company reported progress in its ReSPECT-LM clinical trial for Rhenium (186Re) Obisbemeda, observing no dose-limiting toxicities and a median overall survival of 12 months among participants.
Plus Therapeutics also successfully closed a private placement financing, raising $19.25 million, and received a $3 million grant from the US Department of Defense for pediatric cancer trials.
Moreover, Plus Therapeutics has appointed Dr. Greg Fuller as Vice President of Medical Affairs and Medical Director, who will oversee the implementation of the CNSide® cerebrospinal fluid cancer diagnostic portfolio. The company anticipates a commercial launch of CNSide in Q4 2024.
Plus Therapeutics also received an advance payment of $3.3 million from the Cancer Prevention & Research Institute of Texas to further its leptomeningeal cancer radiotherapeutic development program.
Additionally, Plus Therapeutics revealed its Q1 2024 financial results, highlighting promising survival rates from its radioembolic therapy trials for glioblastoma and leptomeningeal metastases. The company also plans to receive grant advances totaling $6.9 million in 2024. These recent developments illustrate Plus Therapeutics' commitment to advancing its clinical programs and improving its financial health.
InvestingPro Insights
Plus Therapeutics, Inc. (NASDAQ:PSTV) has been making strides in the medical field with its CNSide platform, yet its financial health and market performance present a mixed picture. According to recent data from InvestingPro, the company has a market capitalization of $8.04 million, reflecting its small-cap status in the biopharmaceutical sector. Despite impressive revenue growth over the last twelve months, with an increase of 733.42%, Plus Therapeutics is grappling with significant challenges. The company's gross profit margin stands at a concerning -55.65%, indicating that it is spending more to produce its goods than it's making from sales.
One of the InvestingPro Tips highlights that Plus Therapeutics is quickly burning through its cash reserves. This is a crucial point for investors, as it raises questions about the company's long-term sustainability and its ability to fund ongoing research and development. Moreover, the company's stock has experienced a notable decline over the past week and month, with a one-month price total return of -22.53% and a one-week total return of -11.88%. This could signal investor concerns or a broader market trend affecting the biotech industry.
It's also notable that Plus Therapeutics does not pay a dividend, which may be a factor for income-focused investors to consider. The absence of dividend payments is often typical for clinical-stage companies that prioritize reinvesting earnings back into research and development.
For a more in-depth analysis and additional InvestingPro Tips—such as the company's valuation implications and analyst expectations—interested readers can explore the insights on the Plus Therapeutics InvestingPro page, which includes a total of 11 tips for a comprehensive investment perspective.
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