CNS Pharmaceuticals Presents Update from Ongoing Potentially Pivotal Study of Berubicin Compared with Lomustine in Adult Patients with Recurrent GBM (WHO Grade IV) After Failure of Standard First Line Therapy
CNS Pharmaceuticals (NASDAQ:CNSP) presented updated results from its ongoing pivotal study comparing Berubicin versus Lomustine in adult patients with recurrent glioblastoma (GBM). The study has enrolled 239 patients, with comparable demographics between treatment arms. Key findings show higher study completion rates in the Berubicin arm (84.7% vs 78.9%) and lower withdrawal rates (11.0% vs 19.7%) compared to Lomustine. Safety profiles were similar between arms, with Berubicin showing slightly higher rates of anemia and neutropenia, while Lomustine had more thrombocytopenia cases. The company expects to report primary analysis data in the first half of 2025.
CNS Pharmaceuticals (NASDAQ:CNSP) ha presentato risultati aggiornati dal suo studio fondamentale in corso che confronta Berubicin con Lomustina in pazienti adulti con glioblastoma ricorrente (GBM). Lo studio ha arruolato 239 pazienti, con demografie comparabili tra i gruppi di trattamento. Le principali scoperte mostrano tassi di completamento dello studio più elevati nel gruppo Berubicin (84,7% rispetto al 78,9%) e tassi di rinuncia più bassi (11,0% rispetto al 19,7%) rispetto a Lomustina. I profili di sicurezza erano simili tra i gruppi, con Berubicin che mostrava tassi leggermente più elevati di anemia e neutropenia, mentre Lomustina aveva più casi di trombocitopenia. L'azienda prevede di riportare i dati dell'analisi primaria nella prima metà del 2025.
CNS Pharmaceuticals (NASDAQ:CNSP) presentó resultados actualizados de su estudio pivotal en curso que compara Berubicin con Lomustina en pacientes adultos con glioblastoma recurrente (GBM). El estudio ha inscrito a 239 pacientes, con demografías comparables entre los grupos de tratamiento. Las principales conclusiones muestran tasas de finalización del estudio más altas en el grupo de Berubicin (84.7% frente al 78.9%) y tasas de abandono más bajas (11.0% frente al 19.7%) en comparación con Lomustina. Los perfiles de seguridad fueron similares entre los grupos, con Berubicin mostrando tasas ligeramente más altas de anemia y neutropenia, mientras que Lomustina tuvo más casos de trombocitopenia. La empresa espera informar sobre los datos del análisis primario en la primera mitad de 2025.
CNS Pharmaceuticals (NASDAQ:CNSP)는 재발성 교모세포종(GBM) 성인 환자에서 Berubicin과 로무스틴을 비교하는 진행 중인 주요 연구의 업데이트된 결과를 발표했습니다. 이 연구에는 239명이 등록되었으며, 치료 그룹 간에 인구통계학적 특성이 유사합니다. 주요 발견은 Berubicin 그룹에서 연구 완료율이 더 높다는 것(84.7% 대 78.9%)과 로무스틴에 비해 낮은 중도 탈락률(11.0% 대 19.7%)을 보여줍니다. 안전성 프로필은 두 그룹 간에 유사했으며, Berubicin은 약간 높은 빈도의 빈혈과 호중구감소증을 보였고, 로무스틴은 더 많은 혈소판감소증 사례를 경험했습니다. 이 회사는 2025년 상반기에 주요 분석 데이터를 보고할 것으로 예상하고 있습니다.
CNS Pharmaceuticals (NASDAQ:CNSP) a présenté des résultats actualisés de son étude pivot en cours comparant Berubicin à la Lomustine chez des patients adultes atteints de glioblastome récurrent (GBM). L'étude a recruté 239 patients, avec des caractéristiques démographiques comparables entre les groupes de traitement. Les principales conclusions montrent des taux d'achèvement de l'étude plus élevés dans le groupe Berubicin (84,7 % contre 78,9 %) et des taux de désistement plus faibles (11,0 % contre 19,7 %) par rapport à la Lomustine. Les profils de sécurité étaient similaires entre les groupes, avec Berubicin montrant des taux légèrement plus élevés d'anémie et de neutropénie, tandis que la Lomustine avait plus de cas de thrombocytopénie. L'entreprise s'attend à communiquer les données de l'analyse primaire dans la première moitié de 2025.
CNS Pharmaceuticals (NASDAQ:CNSP) hat aktualisierte Ergebnisse aus seiner laufenden, entscheidenden Studie vorgestellt, die Berubicin mit Lomustin bei erwachsenen Patienten mit wiederkehrendem Glioblastom (GBM) vergleicht. In der Studie wurden 239 Patienten rekrutiert, mit vergleichbaren demografischen Daten zwischen den Behandlungsgruppen. Die wichtigsten Ergebnisse zeigen höhere Abschlussraten der Studie in der Berubicin-Gruppe (84,7% gegenüber 78,9%) und niedrigere Abbruchraten (11,0% gegenüber 19,7%) im Vergleich zu Lomustin. Die Sicherheitsprofile waren zwischen den Gruppen ähnlich, wobei Berubicin leicht höhere Raten von Anämie und Neutropenie aufwies, während Lomustin mehr Fälle von Thrombozytopenie hatte. Das Unternehmen erwartet, die primären Analyseergebnisse in der ersten Hälfte des Jahres 2025 zu berichten.
- Fast Track Designation granted by FDA, enabling expedited development process
- Orphan Drug Designation received, potentially providing 7 years of marketing exclusivity
- Higher study completion rates in Berubicin arm (84.7%) vs Lomustine (78.9%)
- Lower study withdrawal rates in Berubicin arm (11.0%) vs Lomustine (19.7%)
- Higher rates of anemia and neutropenia in Berubicin arm compared to control
- Primary analysis data not available until first half of 2025
Insights
The update from CNS Pharmaceuticals' pivotal Phase 2 trial for Berubicin shows encouraging safety data and trial progress. Key observations include:
- The 239 enrolled patients show balanced demographics and MGMT methylation status between treatment arms, strengthening the study's statistical validity
- Higher study completion rates in the Berubicin arm (
84.7% vs78.9% ) and lower withdrawal rates (11.0% vs19.7% ) suggest potentially better tolerability - Safety profile appears manageable, with Berubicin showing expected hematological effects but notably lower thrombocytopenia compared to Lomustine
The trial's focus on Overall Survival as the primary endpoint, coupled with Fast Track and Orphan Drug designations, positions Berubicin for potential accelerated approval if the data proves positive in H1 2025.
Poster presented at the 29th Annual Meeting of the Society for Neuro-Oncology (SNO 2024)
Primary analysis data in potentially pivotal GBM study with lead program, Berubicin, on track for the first half of 2025
HOUSTON, TX / ACCESSWIRE / November 25, 2024 / 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 announced the presentation of updated results from the on-going potentially pivotal study evaluating Berubicin, the Company's novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier, in a randomized, controlled study vs. Lomustine, which has been considered to be a standard of care in this recurrent glioblastoma population. This was a poster presentation at the 29th Annual Meeting of the Society for Neuro-Oncology held November 21-24, 2024 in Houston, TX.
The poster titled, "Update on a Potentially Pivotal Trial CNS-201: A Randomized, Controlled Trial of Berubicin Vs. Lomustine After First-Line Therapy for Glioblastoma Multiforme (GBM)," was presented bySandra Silberman, MD, PhD, Chief Medical Officer of CNS Pharmaceuticals. The presented poster is now available on the Company's website. The data presented at the SNO Annual Meeting include comparative demographics, disposition of patients, MGMT promoter methylation status and safety, showing that the balance between the randomized arms has been maintained through enrollment of 239 patients into the study.
"Berubicin is being evaluated to demonstrate its potential to provide a much needed clinical benefit for GBM patients. Our team continues to make progress advancing this important clinical program toward the finish line and we look forward to reporting the primary data analysis in the first half of 2025," commented Dr. Silberman.
Summary of Updated Results from the Potentially Pivotal Study:
All patients enrolled show comparable demographics within each arm, including age, gender, race, BSA, and KPS. In addition, patients with unmethylated MGMT comprise approximately
40% in both arms, allowing for a reasonable comparison of efficacy irrespective of the methylation status.
There is a slightly greater percentage of patients on the Berubicin arm compared to the Lomustine arm that have completed the study (
84.7% vs.78.9% ), but a greater percentage of patients on the Lomustine arm have withdrawn from the study (11.0% vs.19.7% ), the most common reasons being patient preference (4.9% vs.9.2% ) and death (1.2% vs.5.3% ).
All grades of any reported adverse events and those of Grade 3-5 in severity occurring in more than
10% of patients are shown to be relatively similar in the Berubicin and Lomustine arms. A slightly greater percentage of patients with all grades or Grades 3-5 with anaemia, headache, and decrease in neutrophil counts were shown in patients receiving Berubicin, while a significantly greater percentage of patients with a decrease in platelet counts and thrombocytopenia occurred in patients receiving Lomustine.
The primary endpoint of the study is Overall Survival (OS), a rigorous endpoint the FDA has recognized as the basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm.
As previously announced in April 2024, the Company completed enrollment with 252 patients in this study evaluating Berubicin vs. Lomustine for the treatment of GBM. In December 2023, the Company announced the successful completion of its pre-planned interim futility analysis of efficacy and safety and received a recommendation from the independent Data Safety Monitoring Board (DSMB) to continue the study without modification.
CNS Pharmaceuticals expects to report primary analysis data from its potentially pivotal study of Berubicin in the first half of 2025. For more information about this trial, visit clinicaltrials.gov and reference identifier NCT04762069.
The FDA has granted CNS Pharmaceuticals Fast Track Designation for Berubicin, which enables more frequent interactions with the agency for guidance on expediting the development and review process. Additionally, the Company has received Orphan Drug Designation from the FDA for using Berubicin to treat malignant glioma, which may provide seven years of marketing exclusivity upon approval of a New Drug Application (NDA).
About Berubicin
Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc. Berubicin was developed by Dr. Waldemar Priebe, Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is a clinical-stage pharmaceutical company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the brain and central nervous system.
The Company's lead drug candidate, 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 including glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer.
The Company's second drug candidate, TPI 287, is an abeotaxane which stabilizes microtubules and inhibits cell division, causing apoptosis and cell death. Similar to Berubicin, TPI 287 has shown the potential to cross the blood-brain barrier and treat CNS tumors. TPI 287 has been well tolerated in over 350 patients to date, including in clinical trials as a monotherapy and in combination with bevacizumab for the treatment of recurrent glioblastoma, neuroblastoma and medulloblastoma, as well as refractory prostate cancer and melanoma, and in tauopathy disease, which can result in dementia.
For more information, please visit www.CNSPharma.com, and connect with the Company on X, Facebook, and LinkedIn.
Forward-Looking Statements
Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements include, without limitation, the timing of the release of the primary analysis data for the potentially pivotal study of Berubicin, the timing of the commencement of the registration study for TPI 287, and the Company's cash runway. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including market and other conditions and those discussed under Item 1A. "Risk Factors" in CNS's most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in its Form 10-Q filings and in its other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except as required by law.
CONTACTS:
Investor Relations Contact
JTC Team, LLC
Jenene Thomas
908.824.0775
CNSP@jtcir.com
SOURCE: CNS Pharmaceuticals, Inc.
View the original press release on accesswire.com
FAQ
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