CNS Pharmaceuticals to Present at 6th Glioblastoma Drug Development Summit
CNS Pharmaceuticals (NASDAQ:CNSP) announced its participation in the 6th Glioblastoma Drug Development Summit in Boston, MA, from February 18-20, 2025. Chief Medical Officer Sandra Silberman, MD, PhD, will present on February 20 at 10:45 AM ET, discussing novel formulations of anthracycline and taxane that can cross the Blood-Brain Barrier (BBB).
The company's lead program, Berubicin, has shown efficacy in Phase 1 and completed enrollment with 252 patients in its pivotal study versus Lomustine for GBM treatment. Primary analysis data is expected in the first half of 2025. CNS is also advancing TPI 287, an abeotaxane showing significant activity in Phase 1b studies.
The FDA has granted Fast Track Designation for Berubicin, allowing more frequent agency interactions, and Orphan Drug Designation for treating malignant glioma, potentially providing seven years of marketing exclusivity upon NDA approval.
CNS Pharmaceuticals (NASDAQ:CNSP) ha annunciato la sua partecipazione al 6° Summit sullo Sviluppo di Farmaci per il Glioblastoma a Boston, MA, dal 18 al 20 febbraio 2025. La Chief Medical Officer Sandra Silberman, MD, PhD, presenterà il 20 febbraio alle 10:45 AM ET, discutendo delle nuove formulazioni di antracicline e taxani in grado di attraversare la Barriera Emato-Encefalica (BBB).
Il programma principale dell'azienda, Berubicin, ha mostrato efficacia nella Fase 1 e ha completato l'arruolamento con 252 pazienti nel suo studio pivotale contro il Lomustine per il trattamento del GBM. I dati dell'analisi primaria sono attesi nella prima metà del 2025. CNS sta anche sviluppando TPI 287, un abeotaxane che ha mostrato un'attività significativa negli studi di Fase 1b.
La FDA ha concesso la Designazione Fast Track per Berubicin, consentendo interazioni più frequenti con l'agenzia, e la Designazione di Farmaco Orfano per il trattamento del glioma maligno, potenzialmente fornendo sette anni di esclusività di commercializzazione dopo l'approvazione della NDA.
CNS Pharmaceuticals (NASDAQ:CNSP) anunció su participación en el 6° Cumbre sobre el Desarrollo de Medicamentos para el Glioblastoma en Boston, MA, del 18 al 20 de febrero de 2025. La Directora Médica Sandra Silberman, MD, PhD, presentará el 20 de febrero a las 10:45 AM ET, discutiendo nuevas formulaciones de antraciclinas y taxanos que pueden cruzar la Barrera Hematoencefálica (BBB).
El programa principal de la compañía, Berubicin, ha mostrado eficacia en la Fase 1 y ha completado el reclutamiento con 252 pacientes en su estudio pivotal frente a Lomustina para el tratamiento del GBM. Se esperan los datos del análisis primario en la primera mitad de 2025. CNS también está avanzando en TPI 287, un abeotaxano que muestra una actividad significativa en los estudios de Fase 1b.
La FDA ha otorgado la Designación de Vía Rápida para Berubicin, permitiendo interacciones más frecuentes con la agencia, y la Designación de Medicamento Huérfano para el tratamiento del glioma maligno, lo que podría proporcionar siete años de exclusividad de comercialización tras la aprobación de la NDA.
CNS Pharmaceuticals (NASDAQ:CNSP)는 2025년 2월 18일부터 20일까지 매사추세츠주 보스턴에서 열리는 제6회 교모세포종 약물 개발 정상 회담에 참여한다고 발표했습니다. 최고 의료 책임자인 Sandra Silberman, MD, PhD는 2월 20일 오전 10시 45분 ET에 발표하며, 혈액-뇌 장벽(BBB)을 통과할 수 있는 새로운 형태의 안트라사이클린 및 탁산에 대해 논의할 예정입니다.
회사의 주요 프로그램인 Berubicin은 1상에서 효능을 보였으며, GBM 치료를 위한 Lomustine과의 주요 연구에 252명의 환자가 등록을 완료했습니다. 주요 분석 데이터는 2025년 상반기에 예상됩니다. CNS는 또한 1b상 연구에서 중요한 활성을 보이는 TPI 287를 발전시키고 있습니다.
FDA는 Berubicin에 대해 신속 승인 지정을 부여하여 더 빈번한 기관 간 상호작용을 허용하고, 악성 교모세포종 치료를 위한 희귀약 지정도 부여하여 NDA 승인 시 7년의 마케팅 독점권을 제공할 수 있습니다.
CNS Pharmaceuticals (NASDAQ:CNSP) a annoncé sa participation au 6ème Sommet sur le Développement de Médicaments pour le Glioblastome à Boston, MA, du 18 au 20 février 2025. La Directrice Médicale Sandra Silberman, MD, PhD, présentera le 20 février à 10h45 ET, discutant de nouvelles formulations d'anthracyclines et de taxanes pouvant traverser la Barrière Hémato-Encephalique (BBB).
Le programme phare de l'entreprise, Berubicin, a montré son efficacité lors de la Phase 1 et a complété l'inscription de 252 patients dans son étude pivot par rapport à la Lomustine pour le traitement du GBM. Les données d'analyse primaire sont attendues dans la première moitié de 2025. CNS avance également TPI 287, un abeotaxane montrant une activité significative dans les études de Phase 1b.
La FDA a accordé la désignation Fast Track pour Berubicin, permettant des interactions plus fréquentes avec l'agence, ainsi que la désignation de Médicament Orphelin pour le traitement du gliome malin, pouvant potentiellement offrir sept ans d'exclusivité commerciale après l'approbation de la NDA.
CNS Pharmaceuticals (NASDAQ:CNSP) gab seine Teilnahme am 6. Gipfel zur Entwicklung von Medikamenten gegen Glioblastom in Boston, MA, vom 18. bis 20. Februar 2025 bekannt. Die Chief Medical Officer Sandra Silberman, MD, PhD, wird am 20. Februar um 10:45 Uhr ET präsentieren und neue Formulierungen von Anthrazyklinen und Taxanen diskutieren, die die Blut-Hirn-Schranke (BBB) überwinden können.
Das Hauptprogramm des Unternehmens, Berubicin, hat in Phase 1 Wirksamkeit gezeigt und hat die Einschreibung mit 252 Patienten in seiner entscheidenden Studie gegen Lomustin für die Behandlung von GBM abgeschlossen. Die primären Analyseergebnisse werden in der ersten Hälfte von 2025 erwartet. CNS entwickelt auch TPI 287, ein Abeotaxan, das in Phase 1b-Studien signifikante Aktivität zeigt.
Die FDA hat Berubicin die Fast-Track-Designierung erteilt, die häufigere Interaktionen mit der Behörde ermöglicht, sowie die Orphan-Drug-Designierung zur Behandlung von malignem Gliom, was potenziell sieben Jahre Marktexklusivität nach der NDA-Zulassung bieten könnte.
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HOUSTON, TX / ACCESS Newswire / February 18, 2025 / 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 it will present at the 6th Glioblastoma Drug Development Summit being held February 18-20, 2025 in Boston, MA.
As part of the event, Sandra Silberman, MD, PhD, Chief Medical Officer of CNS will give an oral presentation titled, "The Use of Traditional Chemotherapy with Activity In the Treatment of Glioblastoma: Novel Formulations of an Anthracylcine & a Taxane That Appear to Cross the Blood-Brain Barrier," on Thursday, February 20, 2025 at 10:45 AM ET.
As part of her presentation, Dr. Silberman will discuss how anthracyclines and taxanes have been indispensable in the treatment of cancer. Despite advancements, anthracyclines and taxanes have not been demonstrated to cross the Blood-Brain Barrier (BBB) in the absence of manipulation, however Dr. Silberman will provide an overview of the Company's reformulated anthracycline and a taxane currently in development, both of which appear to have significant penetration of the BBB and activity in GBM.
The Company's lead program, Berubicin, is an anthracycline with demonstratable efficacy in Phase 1, and as previously announced in April 2024, completed enrollment with 252 patients in its potentially pivotal study of evaluating Berubicin vs. Lomustine for the treatment of GBM. CNS Pharmaceuticals expects to report primary analysis data from this study in the first half of 2025. For more information about this trial, visit clinicaltrials.gov and reference identifier NCT04762069.
Additionally, the Company is advancing TPI 287, an abeotaxane that has shown significant activity in a Phase 1b study. CNS Pharmaceuticals plans to engage the FDA and obtain feedback on the design of a study focused on the registration of TPI 287 in GBM.
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 the 6th Glioblastoma Drug Development Summit
The 6th Glioblastoma Drug Development Summit is the only industry-led event bringing together 90+ experts from pharma, biotech, neuro-oncology, clinical practice, investment, and academia. With a shared goal of improving the lives of patients, this Summit will foster collaboration to advance the development of effective therapies for GBM and other CNS tumors. For more information, please visit the event website.
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 Twitter, 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. 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.
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