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Friday, May 27, 2022 6:40:08 AM
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : May 20, 2022
See Contacts and Locations
Sponsor:
CNS Pharmaceuticals, Inc.
Collaborator:
Worldwide Clinical Trials
Information provided by (Responsible Party):
CNS Pharmaceuticals, Inc.
Status: Recruiting
A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme
Glioblastoma Multiforme, Adult
Interventions:
Drug: Berubicin
Drug: Lomustine
Locations:
Mayo Clinic
Phoenix, Arizona, United States
University of Arkansas
Little Rock, Arkansas, United States
Southern California Permanente Medical Group
Los Angeles, California, United States
(and 48 more...)
No Study Results Posted on ClinicalTrials.gov for this Study
About Study Results Reporting on ClinicalTrials.gov
Recruitment Status : Recruiting
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : February 2025
Current Other Pre-specified Outcome Measures
(submitted: May 10, 2022)
Karnofsky Performance Status [ Time Frame: Through study completion an average of 4 years. ]
Evaluate changes in Karnofsky Performance Status (KPS) score between arms
Evaluate changes in patient-reported outcomes [ Time Frame: Through study completion an average of 4 years. ]
Evaluate changes in patient-reported outcomes between arms.
Explore the effect of O[6] methylguanine-DNA methyltransferase (MGMT) methylation [ Time Frame: Through study completion an average of 4 years. ]
explore the effect of O[6] methylguanine-DNA methyltransferase (MGMT) methylation status on response to berubicin and comparison of theses subsets between arms
Impact of re-resection [ Time Frame: Through study completion an average of 4 years. ]
Impact of re-resection on outcomes
Use of bevacizumab [ Time Frame: Through study completion an average of 4 years. ]
Use of bevacizumab between the arms.”
https://clinicaltrials.gov/ct2/show/results/NCT04762069?id=NCT04762069&draw=2&rank=1
“9:21a ET 3/9/2022 - Benzinga
CNS Pharmaceuticals Addresses Recent Share Price Activity
Mentioned: CNSP
Video from John Climaco, CEO of CNS Pharmaceuticals now available on the Company's website
HOUSTON, March 9, 2022 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today released a video to shareholders reiterating its operational and clinical progress for lead product candidate, Berubicin, and addressing recent share price activity.
"The divergence that exists between our operational strength and share price is top of mind for myself and the whole team at CNS Pharmaceuticals. As a shareholder of CNS Pharma, I share in the frustrations as it pertains to the share price and fluctuation in the market â?? both of which are things out of our control. However, as the CEO, what I do have control over is executing on the day-to-day operations, which I want to reiterate and emphasize, have simply never been stronger. We continue to enroll patients around the world in our potentially pivotal study of Berubicin in the treatment of adult GBM. We have the leading minds in the field around the world working on this trial with us and we have encouraging ongoing dialogue with the FDA to ensure that our potentially pivotal trial continues to represent the state-of-the-art in the field. So, while what we cannot control remains to be a point of frustration, we are committed to continuing to execute our operational excellence to drive recognition in the market of Berubicin and what we believe could be its immense potential for patients â?? the key driver for ultimately generating shareholder value and tremendous hope for GBM patients worldwide," commented John Climaco, CEO of CNS Pharmaceuticals. "We put our heads down every day and continue to charge forward in our mission to change the game in glioblastoma via Berubicin."
Berubicin is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently in development for the treatment of a number of serious brain and CNS oncology indications. Patient enrollment, randomization and dosing is currently underway, and the Company has a robust lineup of clinical sites located globally which are advancing toward activation and enrollment.
For more information about the ongoing potentially pivotal Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069.
To access the video, please visit the Company's website.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.”
I expect first results in September/October 2022 given that first results are provided when 50% of all patients are 6 months into the trial, and 6 months after the PR above is September.
my posts are always theory and not financial advice
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