Clinical-stage Therapeutics Company Presents Positive Clinical Trial Results
Clinical-stage Therapeutics Company Presents Positive Clinical Trial Results
Plus Therapeutics Announces Encouraging Clinical Trial Outcomes at the 2024 SNO/ASCO CNS Metastases Conference.
Disclaimer: This blog article is intended for informational purposes only and does not constitute medical advice or an endorsement of any specific treatment, product, or company. Readers should consult with healthcare professionals for medical advice and information about treatment options.
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Plus Therapeutics, Inc. (Nasdaq: PSTV), a clinical-stage pharmaceutical company, recently presented promising data from their ReSPECT-LM clinical trial at the 2024 Society for Neuro-Oncology (SNO) and American Society for Clinical Oncology (ASCO) CNS Metastases Conference. The trial focuses on evaluating the safety and efficacy of Rhenium (186Re) Obisbemeda (Rhenium Nanoliposome, 186RNL) for treating leptomeningeal disease (LM), a severe complication of various cancers.
The ReSPECT-LM Clinical Trial
The ReSPECT-LM clinical trial aims to address an urgent need for effective treatments for leptomeningeal metastases (LM). LM is a condition where cancer spreads to the cerebrospinal fluid (CSF) and the leptomeninges surrounding the brain and spinal cord. This condition is particularly challenging to treat due to the difficulty in delivering therapeutics across the blood-brain barrier. Dr. Andrew Brenner, M.D., Ph.D., presented the interim results of the Phase 1 dose escalation study. The study reviewed the initial safety and feasibility of Rhenium (186Re) Obisbemeda in treating LM. Key highlights from the first four cohorts of the trial include:
Patient Demographics and Treatment: Sixteen patients have been treated so far, with a variety of primary cancer diagnoses. Eight patients had breast cancer, four had lung cancer, and the remaining four had other types of primary cancers.
Safety Profile: There were no dose-limiting toxicities observed through cohort 4, and the maximum tolerated or feasible dose was not reached. This indicates a favorable safety profile for the therapeutic.
Radiation Dosage: A linear increase in absorbed radiation dose to the spinal fluid, ventricles, and cranial subarachnoid space was observed across the four cohorts. In cohort 4, the mean absorbed radiation dose to the ventricles and cranial subarachnoid space was 156 Gy compared to 1 Gy to the spleen.
Adverse Events: Most adverse events were mild or moderate and were unrelated or unlikely related to the study drug.
Efficacy Indicators: There was a mean reduction of circulating tumor cells (CTCs) in the CSF by 53% at 28 days post-treatment compared to baseline. This measurement was taken from cohorts 1-3.
Overall Survival: The median overall survival for cohorts 1-4 was 12 months, with eight of the sixteen patients still alive at the time of analysis.
Dr. Brenner emphasized the encouraging nature of these findings, particularly the median overall survival rate of 12 months. This result is significant given the typical prognosis for LM patients, who often face limited survival times due to the aggressive nature of the disease and the lack of effective treatments.
Leptomeningeal Metastases
Leptomeningeal metastases occur when cancer cells spread to the CSF and the leptomeninges. This complication can arise from various malignancies, including solid tumors, primary brain tumors, and hematological malignancies. Breast cancer is the most common primary cancer leading to LM, affecting 3-5% of breast cancer patients. Lung cancer, gastrointestinal cancers, and melanoma are also known to spread to the CSF, resulting in LM.
LM is a severe and usually terminal condition with very low survival rates; only 7% of patients survive one year, and 3% survive two years. The increasing incidence of LM is partly due to the longer survival of cancer patients and the inability of standard chemotherapies to effectively target tumor cells within the spinal fluid. Rhenium (186Re) Obisbemeda represents a novel therapeutic approach designed to deliver targeted high-dose radiation directly to CNS tumors. This injectable radiotherapy aims to optimize patient outcomes by reducing off-target risks and providing potent radiation doses.
Rhenium-186 is particularly suitable for CNS therapeutic applications due to its short half-life, beta energy for tissue destruction, and gamma energy for real-time imaging. This makes it an ideal candidate for treating conditions like recurrent glioblastoma and leptomeningeal metastases.
Plus Therapeutics' Broader Clinical Pipeline
Plus Therapeutics is advancing a pipeline of targeted radiotherapeutics using image-guided local beta radiation and targeted drug delivery approaches. Their lead programs focus on recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The ReSPECT-LM clinical trial is partially funded by a three-year, $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT). CPRIT has played a significant role in advancing cancer research and prevention efforts in Texas, awarding over $3 billion in grants to various research institutions and organizations.
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company dedicated to developing targeted radiotherapeutics for challenging CNS cancers. The company has established a robust supply chain through strategic partnerships, enabling the development, manufacturing, and potential future commercialization of its products. Plus Therapeutics operates in key cancer clinical development hubs, including Austin and San Antonio, Texas. CPRIT was created to lead Texas's fight against cancer, with a substantial investment in cancer research and prevention. CPRIT has awarded grants, recruited top researchers, and supported the establishment and expansion of companies focused on cancer research within Texas. The institute has made substantial contributions to scientific and clinical knowledge and has provided millions of cancer prevention and early detection services across Texas.
The interim results from Plus Therapeutics' ReSPECT-LM clinical trial offer hope for patients with leptomeningeal metastases. The promising safety and efficacy profile of Rhenium (186Re) Obisbemeda could lead to a new therapeutic option for this challenging condition. Continued research and clinical trials are essential to validate these findings and potentially bring a new treatment to market.
Disclaimer: This blog article is intended for informational purposes only and does not constitute medical advice or an endorsement of any specific treatment, product, or company. Readers should consult with healthcare professionals for medical advice and information about treatment options.
We are working endlessly to provide free insights on the stock market every day, and greatly appreciate those who are paid members supporting the development of the Stock Region mobile application. Stock Region offers daily stock and option signals, watchlists, earnings reports, technical and fundamental analysis reports, virtual meetings, learning opportunities, analyst upgrades and downgrades, catalyst reports, in-person events, and access to our private network of investors for paid members as an addition to being an early investor in Stock Region. We recommend all readers to urgently activate their membership before reaching full member capacity (500) to be eligible for the upcoming revenue distribution program. Memberships now available at https://stockregion.net