berubicin (RTA 744) / CNS Pharma, WPD Pharma - LARVOL DELTA

Updates on a potentially pivotal trial CNS-201: A randomized, controlled trial of Berubicin vs. Lomustine after first-line therapy for Glioblastoma Multiforme (GBM) (SNO 2024) - No abstract available

Clinical • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

CNS Pharmaceuticals Reports Second Quarter 2024 Financial Results (CNS Pharma Press Release) - "Berubicin:...CNS Pharmaceuticals expects to report topline results from its potentially pivotal study of Berubicin in the first half of 2025...CNS Pharmaceuticals plans to engage the U.S. FDA and obtain feedback on the design of a study focused on the registration of TPI 287 in recurrent GBM, with the goal of initiating the study in 2025."

FDA event • New trial • P2 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

CNS Pharmaceuticals Announces Acceptance of Abstract for Poster Presentation at the 2024 SNO/ASCO CNS Cancer Conference (Yahoo Finance) - "CNS Pharmaceuticals, Inc...today announced that its abstract has been selected for poster presentation at the 2024 SNO/ASCO CNS Cancer Conference being held August 8-10, 2024 in Denver, CO."

Preclinical • Glioblastoma

A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme (clinicaltrials.gov) - P2 | N=210 | Active, not recruiting | Sponsor: CNS Pharmaceuticals, Inc. | Trial primary completion date: Sep 2024 ➔ Dec 2024

Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • MGMT

Interactions of a Novel Anthracycline with Oligonucleotide DNA and Cyclodextrins in an Aqueous Environment. (PubMed, J Phys Chem B) - "Selected structural and geometrical properties of all the complexes, which are all stable, are analyzed. Both cyclodextrins under consideration are widely utilized for drug delivery purposes, and a comparative investigation between their bound states with berubicin is carried out."

Journal

A Multicenter, Study of the Safety and Pharmacokinetics of Intravenously Infused Berubicin in Pediatric Patients With Progressive, Refractory, or Recurrent High Grade Gliomas (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: WPD Pharmaceuticals Sp. z o.o. | N=35 ➔ 0 | Trial completion date: Dec 2025 ➔ Dec 2023 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Dec 2025 ➔ Dec 2023

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Brain Cancer • CNS Tumor • Glioma • Oncology • Pediatrics • Solid Tumor

Berubicin in Adult Patients With Recurrent Glioblastoma Multiforme (WHO Grade IV) (clinicaltrials.gov) - P1/2 | N=5 | Terminated | Sponsor: WPD Pharmaceuticals Sp. z o.o. | N=50 ➔ 5 | Trial completion date: Oct 2025 ➔ Dec 2023 | Recruiting ➔ Terminated | Trial primary completion date: Oct 2025 ➔ Dec 2023; Business decision

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • MGMT

CNS Pharmaceuticals Reports Full Year 2023 Financial Results and Highlights Recent Corporate and Clinical Achievements (ACCESSWIRE) - "The Company expects to report topline data from its study of Berubicin in the first half of 2025, although it is impossible to accurately predict how long patients on the study may survive, which could impact the timing of the release of topline data."

P2 data • Glioblastoma

CNS Pharmaceuticals Achieves Completion of Planned Enrollment in Potentially Pivotal Study of Berubicin for the Treatment of Glioblastoma Multiforme (GBM) (CNS Pharma Press Release) - "CNS Pharmaceuticals, Inc...announced completion of planned enrollment in its global potentially pivotal study evaluating Berubicin, the Company's novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier, for the treatment of GBM, an aggressive and incurable form of brain cancer."

Enrollment closed • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

CNS Pharmaceuticals Announces Successful Interim Analysis of Efficacy and Safety Data in Potentially Pivotal Study of Berubicin (CNS Pharma) - "Enrollment expected to be complete in early Q1 2024...CNS Pharmaceuticals, Inc...announced the recommendation of the independent Data Safety Monitoring Board (DSMB) that the Company's ongoing global, potentially pivotal trial of the investigational agent, Berubicin for the treatment of glioblastoma multiforme (GBM) continue without any modification. The recommendation follows the DSMB's pre-specified futility analysis of unblinded (to the DSMB only) efficacy and safety data in the Company's trial of Berubicin versus Lomustine, a standard of care in patients with recurrent GBM. More specifically, the DSMB reviewed the primary endpoint of overall survival (OS) and secondary efficacy measures progression-free survival (PFF) and overall response rate (ORR), as well as safety data in evaluable patients. In order to support continuing the trial, Berubicin's efficacy had to be at least comparable to Lomustine's on the primary endpoint (OS)."

DSMB • Enrollment status • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

CNS Pharmaceuticals (NASDAQ: CNSP) Presents Updated Safety Data from Ongoing Potentially Pivotal Study Evaluating Berubicin in Advance of the Pre-Planned Interim Analysis of Efficacy (Issuer Direct) - P2 | N=210 | NCT04762069 | Sponsor: CNS Pharmaceuticals, Inc. | "CNS Pharmaceuticals, Inc...announced the presentation of updated safety data from the ongoing potentially pivotal study evaluating Berubicin, the Company's novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier, in a poster presentation at the SNO 28th Annual Meeting, held November 15-19, 2023 in Vancouver, Canada....All reported adverse events for both arms are shown for all grades and grades 3-5. These were similar, including the more severe events in the higher grades. The adverse events occurring in more than 10% of patients and/or that were considered treatment-related, are shown for all grades as well as grades 3-5, and overall were relatively similar in the Berubicin and Lomustine arms."

P2 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

CNS Pharmaceuticals To Release Interim Data By The End Of The Year For Potential Glioblastoma Drug Candidate (CNS Pharma) - "In October, the company announced that 229 out of 243 expected patients had already been enrolled in their ongoing study evaluating the effectiveness of Berubicin for recurrent GBM...Currently, the company has opened 46 clinical trial sites out of approximately 60 selected locations across the United States, Italy, France, Spain and Switzerland...The company reports that its safety analysis is also showing that the drug is well tolerated by patients...During this analysis, an independent data safety monitoring board (DSMB) closely examines the number of deaths in each treatment group to ensure that patients receiving Berubicin show a significant improvement in overall survival compared to those receiving Lomustine....The company is confident that it will share the results from this interim analysis with the public before the end of the year."

P2 data • Trial status • Glioblastoma

CNS Pharmaceuticals Reports Third Quarter 2023 Financial Results and Reiterates Company is on Track to Achieve Milestones for Berubicin Potentially Pivotal Study Before Year End (Issuer Direct) - "Upcoming Expected Milestones: (i) Report topline results of interim analysis expected in December 2023. Enrollment will continue during the interim analysis; (ii) Complete enrollment in December 2023."

Enrollment status • P2 data • Glioblastoma

A randomized, controlled trial of Berubicin vs. Lomustine after first-line therapy for Glioblastoma Multiforme (GBM): Interim results of a pre-planned analysis of overall survival (OS) (SNO 2023) - "Berubicin is an analog of doxorubicin (Dox) that appears to cross the BBB with significant central nervous system (CNS) uptake. The review will also include safety and secondary efficacy endpoint summaries. Results of this interim analysis will be available for the SNO annual meeting and an evaluation of its outcome will be performed, with conclusions and recommendations for the further development of Berubicin as a therapeutic option for patients with recurrent GBM."

Clinical • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • MGMT

CNS Pharmaceuticals' (NASDAQ:CNSP) Ongoing Potentially Pivotal Study of Berubicin for the Treatment of Glioblastoma Multiforme (GBM) Continues Rapid Pace of Enrollment with 229 Patients Enrolled to Date (Issuer Direct) - "CNS Pharmaceuticals...announced it has achieved enrollment of 229 of the expected 243 patients in the ongoing potentially pivotal study evaluating Berubicin for the treatment of recurrent GBM, an aggressive and incurable form of brain cancer. The Company has opened 46 clinical trial sites across the U.S., Italy, France, Spain, and Switzerland....Upcoming Expected Milestones: (i) Report topline results of interim analysis expected in Q4 2023. Enrollment will continue during the interim analysis; (ii) Complete enrollment in Q4 2023."

Enrollment status • P2 data • Glioblastoma

A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme (clinicaltrials.gov) - P2 | N=210 | Active, not recruiting | Sponsor: CNS Pharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • MGMT

CNS Pharmaceuticals (NASDAQ: CNSP) Reaches Milestone with Enrollment of 200 Patients in Ongoing Potentially Pivotal Study of Berubicin with the Treatment of Glioblastoma Multiforme (GBM) (Issuer Direct) - "CNS Pharmaceuticals...announced that 200 of the expected 243 patients have now been enrolled in the Company's ongoing potentially pivotal study evaluating Berubicin for the treatment of recurrent GBM, an aggressive and incurable form of brain cancer. This potentially pivotal, global study of Berubicin is an adaptive, multicenter, open-label, randomized controlled study in adult patients with recurrent GBM (WHO Grade IV) after failure of standard first-line therapy and compared to Lomustine as the standard of care (SOC)."

Enrollment status • Glioblastoma

CNS Pharmaceuticals (NASDAQ: CNSP) Presents Updated Results from On-Going Potentially Pivotal Study of Berubicin in Adult Patients with Recurrent GBM (WHO Grade IV) After Failure of Standard First Line Therapy (CNS Pharma) - P2 | N=210 | NCT04762069 | Sponsor: CNS Pharmaceuticals, Inc. | "CNS Pharmaceuticals, Inc...today announced the presentation of updated results from the on-going potentially pivotal study evaluating Berubicin...in a poster presentation at the 2023 SNO/ASCO CNS Cancer Conference, held August 10-12, 2023 in San Francisco, CA....In addition, patients have been stratified by MGMT methylation, allowing a reasonable comparison of efficacy based on this prognostic feature between the two groups. The unmethylated MGMT population comprises approximately 38% of all enrolled patients. Approximately 50% of patients on both arms have completed the study, i.e. have participated in an end of treatment (EOT) visit, and withdrawal prior to EOT is relatively small, although almost twice the percent of patients in the Lomustine group compared to Berubicin have withdrawn."

P2 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

CNS Pharmaceuticals Reports Second Quarter 2023 Financial Results and Reiterates Upcoming Milestones (Issuer Direct) - "Continued rapid pace of enrollment with ~75% of expected patients now enrolled in ongoing potentially pivotal study evaluating Berubicin for the treatment of GBM....Achieve enrollment of 200th patient in Q3 2023. Report topline results of interim analysis expected in Q4 2023. Complete enrollment in Q4 2023....As of June 30, 2023, the Company had cash of approximately $4.3 million and working capital of approximately $2.1 million. The Company's current expectation is that the cash on hand is sufficient to fund operations into the fourth quarter of 2023, through the topline data readout for the Berubicin potentially pivotal study."

Commercial • Enrollment status • P2 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

CNS Pharmaceuticals Provides Clinical Trial Update for Ongoing Potentially Pivotal Study with Berubicin for the Treatment of Glioblastoma Multiforme (GBM) (CNS Pharma) - "Completion of enrollment of study expected by end of 2023...Topline data from interim analysis expected before year end...CNS Pharmaceuticals, Inc...today provided a clinical update for its ongoing clinical study evaluating Berubicin for the treatment of recurrent GBM, an aggressive and incurable form of brain cancer....To date, 180 patients of the expected 243 patients have been enrolled in the study....Reached 74% enrollment in study; Pace of enrollment is rapidly accelerating with the first 75 patients taking 18 months to enroll while the second 75 patients took less than 6 months to enroll; Enrolled 25 patients in June; and Expanded study with commencement of enrollment and dosing in Italy."

Enrollment status • P2 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

CNS Pharmaceuticals (NASDAQ:CNSP) Announces Acceptance of Abstract for Poster Presentation at the 2023 SNO/ASCO CNS Cancer Conference (CNS Pharma) - "CNS Pharmaceuticals, Inc...announced that its abstract has been selected for in-person poster presentation at the 2023 SNO/ASCO CNS Cancer Conference being held August 10-12, 2023 in San Francisco, CA...Details of the presentation are as follows:...Title: A randomized, controlled trial of Berubicin, a topoisomerase II poison that appears to cross the blood-brain barrier (BBB), after first-line therapy for glioblastoma multiforme (GBM): Preliminary Results"

Clinical data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

CNS Pharmaceuticals (NASDAQ:CNSP) Achieves Over 50% Completion of Enrollment in Potentially Pivotal Study with Berubicin for the Treatment of Glioblastoma Multiforme (GBM) (CNS Pharma) - "Company continues to execute on rapid progression of enrollment toward planned interim analysis expected in the third quarter of 2023. 45 clinical trial sites of the 60 sites selected across the U.S., Italy, France, Spain, and Switzerland open and enrolling patients...today announced that its ongoing potentially pivotal study evaluating Berubicin for the treatment of recurrent glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer, has enrolled 134 patients, representing more than 50% of the total planned enrollment for the study."

Trial status • Glioblastoma • Oncology • Solid Tumor

CNS Pharmaceuticals to Present at the Virtual Investor Spotlight Event - Rapidly Advancing GBM Pivotal Study (Issuer Direct) - "CNS Pharmaceuticals...announced that it will present at the Virtual Investor Spotlight Event - Rapidly Advancing GBM Pivotal Studyon Wednesday, May 3, 2023 at 12:00 PM ET. As part of the event,...CNS Pharmaceuticals will discuss the progress of its ongoing potentially pivotal study evaluating Berubicin for the treatment of recurrent glioblastoma multiforme (GBM), one of the most aggressive types of brain cancer. To date, the Company has opened 44 clinical trial sites of the 60 sites selected across the U.S., Italy, France, Spain, and Switzerland and recently announced that over 100 patients have been enrolled in the study. The Company expects to conduct a pre-planned interim analysis in the third quarter of 2023."

P2 data • Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Over 100 Patients Now Enrolled in CNS Pharmaceuticals’ (NASDAQ: CNSP) Potentially Pivotal Study Evaluating Berubicin for the Treatment of Glioblastoma Multiforme (GBM) (Issuer Direct) - "CNS Pharmaceuticals...announced that over 100 patients have been enrolled in the Company's potentially pivotal study with their lead product candidate, Berubicin....'Enrolling over 100 patients in this relatively rare disease in a little more than 18 months is a remarkable achievement which speaks to the unmet clinical need in GBM and the excitement about Berubicin in the neuro-oncology clinical community worldwide'."

Enrollment status • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

CNS Pharmaceuticals Receives Approval from Competent Authority and Central Ethics Committee in Italy for Potentially Pivotal Global Trial Evaluating Berubicin for the Treatment of GBM (BioSpace) - "CNS Pharmaceuticals...announced it has received approval from the Italian Medicines Agency ('AIFA') Competent Authority and the A.O.U. Policlinico di Bari Ethics Committee for its ongoing potentially pivotal global trial evaluating Berubicin for the treatment of recurrent glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer....The Company plans to open its clinical sites in Italy imminently in addition to the previously opened 41 clinical trial sites of the 60 sites selected across the U.S., France, Spain, and Switzerland....Enrollment continuing to progress toward an interim analysis expected in the third quarter of 2023."

Enrollment status • European regulatory • P2 data • Brain Cancer • Glioblastoma • Oncology • Solid Tumor