A Phase 1 Study of TPI 287 Concurrent With Fractionated Stereotactic Radiotherapy (FSRT) in Treatment of Brain Metastases From Advanced Breast and Non-Small Cell Lung (NSCL) Cancer

The main purpose of this study is to see whether addition of TPI 287 to FSRT is safe and tolerable. Researchers also want to find out if adding TPI 287 to FSRT can help with better controlling the growth of brain lesions in people with brain metastases from their cancer.

开始日期2014-10-09

申办/合作机构

H. Lee Moffitt Cancer Center & Research Institute, Inc.

[+1]

NCT02133846

/ Completed临床1期IIT

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohort, Dose-Ranging Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of TPI 287 in Patients With Primary Four Repeat Tauopathies: Corticobasal Syndrome or Progressive Supranuclear Palsy

The purpose of this study is to determine the safety and tolerability [maximum tolerated dose (MTD) within planned dosing range] of intravenous (IV) infusions of TPI 287 administered once every 3 weeks for 9 weeks (for a total of 4 infusions) in patients with primary four repeat tauopathies (4RT), corticobasal syndrome (CBS; also called corticobasal degeneration, CBD) or progressive supranuclear palsy (PSP).

开始日期2014-05-01

申办/合作机构

The University of California, San Francisco

[+2]

NCT02047214

/ Terminated临床2期

Phase 2 Dose-Escalation Study of TPI 287 in Combination With Bevacizumab in Adults With Recurrent or Progressive Glioblastoma Following a Bevacizumab-Containing Regimen

The purpose of this study is to evaluate the safety, maximum tolerated dose (MTD), and efficacy of TPI 287 in combination with Avastin (bevacizumab) in subjects who have glioblastoma multiforme (GBM) that has progressed following prior radiation and temozolomide (TMZ) therapy and that has progressed following prior bevacizumab therapy.

开始日期2014-01-01

申办/合作机构

Cortice Biosciences, Inc.

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100 项与 ARC-100 相关的专利（医药）

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项与 ARC-100 相关的文献（医药）

2024-01-01·Neuro-oncology advances

Phase 1 trial of TPI 287, a microtubule stabilizing agent, in combination with bevacizumab in adults with recurrent glioblastoma

Article

作者: Benkers, Tara ; Singer, Samuel ; Duic, Paul J ; Hsu, Sigmund ; Rao, Mayank ; Goldlust, Samuel A ; Nabors, Louis B ; Silberman, Sandra L ; Mohile, Nimish ; Cappello, Lori ; Farmer, George

Abstract:

Background:

Recurrent glioblastoma (rGBM) has limited treatment options. This phase 1 protocol was designed to study the safety and preliminary efficacy of TPI 287, a central nervous system penetrant microtubule stabilizer, in combination with bevacizumab (BEV) for the treatment of rGBM.

Methods:

GBM patients with up to 2 prior relapses without prior exposure to anti-angiogenic therapy were eligible. A standard 3 + 3 design was utilized to determine the maximum tolerated dose (MTD) of TPI 287. Cohorts received TPI 287 at 140–220 mg/m2 every 3 weeks and BEV 10 mg/kg every 2 weeks during 6-week cycles. An MRI was performed after each cycle, and treatment continued until progression as determined via response assessment in neuro-oncology criteria.

Results:

Twenty-four patients were enrolled at 6 centers. Treatment was generally well tolerated. Fatigue, myelosuppression, and peripheral neuropathy were the most common treatment emergent adverse events. Dose-limiting toxicity was not observed, thus the MTD was not determined. Twenty-three patients were evaluable for median and 6-month progression-free survival, which were 5.5 months (mo) and 40%, respectively. Median and 12-month overall survival were 13.4 mo and 64%, respectively. The optimal phase 2 dose was determined to be 200 mg/m2.

Conclusions:

TPI 287 can be safely combined with BEV for the treatment of rGBM and preliminary efficacy supports further investigation of this combination.

2020-02-01·JAMA neurology1区 · 医学

Reactions to Multiple Ascending Doses of the Microtubule Stabilizer TPI-287 in Patients With Alzheimer Disease, Progressive Supranuclear Palsy, and Corticobasal Syndrome

1区 · 医学

Article

作者: Geldmacher, David S. ; Koestler, Mary ; Hare, Emma ; Powers, Ryan ; Shamloo, Merhdad ; Jung, Joo In ; Rosen, Howard J. ; Tsai, Richard M. ; Chuu, Emmeline L. ; Luong, Phi N. ; Mumford, Paige ; Rabinovici, Gil D. ; Wolf, Amy ; Miller, Zachary ; Boxer, Adam L. ; Ljubenkov, Peter A. ; Natelson-Love, Marissa ; Miller, Bruce L. ; Fagan, Anne M. ; Cobigo, Yann ; Wang, Ping ; Rojas, Julio C. ; McKinley, Emily C. ; Roberson, Erik D. ; Brown, Jesse A.

Importance:

Basket-design clinical trials that allow investigation of treatment effects on different clinical syndromes that share the same molecular pathophysiology have not previously been attempted in neurodegenerative disease.

Objective:

To assess the safety, tolerability, and pharmacodynamics of the microtubule stabilizer TPI-287 (abeotaxane) in Alzheimer disease (AD) or the 4-repeat tauopathies (4RT) progressive supranuclear palsy (PSP) and corticobasal syndrome (CBS).

Design, Setting, and Participants:

Two parallel-design, double-blind, placebo-controlled phase 1 randomized clinical trials in AD and 4RT were conducted from December 20, 2013, through May 4, 2017, at the University of California, San Francisco, and University of Alabama at Birmingham. A total of 94 patients with clinically diagnosed AD (n = 39) and 4RT (n = 55) were screened; of these, 3 refused to participate, and 10 with AD and 11 with 4RT did not meet inclusion criteria. A total of 29 patients with AD, 14 with PSP, and 30 with β-amyloid-negative CBS (determined on positron emission tomography findings) were enrolled. Data were analyzed from December 20, 2013, through May 4, 2017, based on modified intention to treat.

Interventions:

Randomization was 8:3 drug to placebo in 3 sequential dose cohorts receiving 2.0, 6.3, or 20.0 mg/m2 of intravenous TPI-287 once every 3 weeks for 9 weeks, with an optional 6-week open-label extension.

Main Outcomes and Measures:

Primary end points were safety and tolerability (maximal tolerated dose) of TPI-287. Secondary and exploratory end points included TPI-287 levels in cerebrospinal fluid (CSF) and changes on biomarker, clinical, and neuropsychology measures.

Results:

A total of 68 participants (38 men [56%]; median age, 65 [range, 50-85] years) were included in the modified intention-to-treat analysis, of whom 26 had AD (14 women [54%]; median age, 63 [range, 50-76] years), and 42 had 4RT (16 women [38%]; median age, 69 [range, 54-83] years). Three severe anaphylactoid reactions occurred in TPI-287-treated patients with AD, whereas none were seen in patients with 4RT, leading to a maximal tolerated dose of 6.3 mg/m2 for AD and 20.0 mg/m2 for 4RT. More falls (3 in the placebo group vs 11 in the TPI-287 group) and a dose-related worsening of dementia symptoms (mean [SD] in the CDR plus NACC FTLD-SB [Clinical Dementia Rating scale sum of boxes with frontotemporal dementia measures], 0.5 [1.8] in the placebo group vs 0.7 [1.6] in the TPI-287 group; median difference, 1.5 [95% CI, 0-2.5]; P = .03) were seen in patients with 4RT. Despite undetectable TPI-287 levels in CSF, CSF biomarkers demonstrated decreased chitinase-3-like protein-1 (YKL-40) levels in the 4RT treatment arm (mean [SD], -8.4 [26.0] ng/mL) compared with placebo (mean [SD], 10.4 [42.3] ng/mL; median difference, -14.6 [95% CI, -30.0 to 0.2] ng/mL; P = .048, Mann-Whitney test).

Conclusions and Relevance:

In this randomized clinical trial, TPI-287 was less tolerated in patients with AD than in those with 4RT owing to the presence of anaphylactoid reactions. The ability to reveal different tau therapeutic effects in various tauopathy syndromes suggests that basket trials are a valuable approach to tau therapeutic early clinical development.

Trial Registration:

ClinicalTrials.gov identifiers: NCT019666666 and NCT02133846.

2018-05-01·Journal of neuro-oncology2区 · 医学

The CNS penetrating taxane TPI 287 and the AURKA inhibitor alisertib induce synergistic apoptosis in glioblastoma cells

2区 · 医学

Article

作者: Urio, Sara ; Lehman, Norman L ; Mifsud, Caroline S ; McElroy, Joseph P ; Dalton, Hailey M ; Bryant, William M ; King, Paul D ; Li, Xiaohui ; Sak, Muge ; Zumbar, Cory T ; Usubalieva, Aisulu ; Farmer, George

Glioblastoma is a highly malignant disease in critical need of expanded treatment options. The AURKA inhibitor alisertib exhibits antiproliferative activity against glioblastoma in vitro and in vivo. Unlike current clinically used taxane drugs, the novel taxane TPI 287 penetrates the CNS. We tested for interactions between three selective AURKA inhibitors and TPI 287 against standard U87 and U1242 cells and primary glioblastoma neurospheres using colony formation assays. Bliss and Chou-Talalay analyses were utilized to statistically test for synergism. Morphological analysis, flow cytometry and annexin V binding were employed to examine cell cycle and apoptotic effects of these drug combinations. TPI 287 not only potentiated the cytotoxicity of the AURKA inhibitors alisertib, MLN8054 and TC-A2317, but was often potently synergistic. Morphologic and biochemical analysis of the combined effects of alisertib and TPI 287 consistently revealed synergistic induction of apoptosis. While each agent alone induces a mitotic block, slippage occurs allowing some tumor cells to avoid apoptosis. Combination treatment greatly attenuated mitotic slippage, committing the majority of cells to apoptosis. Alisertib and TPI 287 demonstrate significant synergism against glioblastoma cells largely attributable to a synergistic effect in inducing apoptosis. These results provide compelling rationale for clinical testing of alisertib and/or other AURKA inhibitors for potential combination use with TPI 287 against glioblastoma and other CNS neoplasms.

项与 ARC-100 相关的新闻（医药）

2026-01-28

·BioSpace

CNS Pharmaceuticals Issues Letter to Shareholders - January 27, 2026

Newly Appointed President & Chief Executive Officer, Rami Levin, Discusses Plans for a New Era at CNS Pharmaceuticals Strategic Focus, Pipeline Optimization and Formalizing Roadmap for Near and Long-Term Value Creation HOUSTON, TX / ACCESS Newswire / January 27, 2026 / 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 issued a Letter to Shareholders from its newly appointed President and Chief Executive Officer, Rami Levin. Dear Fellow Shareholders, I am honored to write to you for the first time in my role as President and Chief Executive Officer of CNS Pharmaceuticals. I have stepped into this role with deep respect for the science, the people, and the shareholders who have supported this Company to date. CNS Pharmaceuticals was founded with a vision to address life threatening diseases with a high unmet medical need, and our focus now is to pursue that mission with clarity, discipline, and a strong commitment to execution and value creation for our shareholders. Strategic Imperative: Evaluation with Purpose Since joining CNS Pharmaceuticals as President & CEO, I have commenced a comprehensive evaluation of the company. This includes a thorough review of our pipeline, development priorities, operational structure, and capital allocation strategy. This process is not about narrowing our ambitions. It is about sharpening them with strategic intent to ensure that our Company is positioned to pursue meaningful, high-value therapeutic opportunities where we believe we can deliver real patient impact and robust long-term shareholder returns. Our evaluation will be guided by three core principles: Patients First. Every program we advance must address a serious condition with clear unmet medical need grounded in strong scientific and commercial rationale, a credible path to meaningful clinical benefit, and a realistic opportunity to improve patient outcomes. Pipeline Enrichment and Optimization. Alongside evaluating opportunities to enhance the pipeline through prioritization and business development opportunities, we are equally focused on optimizing our TPI 287 program. This includes honing the development and regulatory strategies for TPI 287 to ensure they are positioned as efficiently and effectively as possible for clinical advancement and a successful outcome. Disciplined Value Creation. We recognize the responsibility we have to our shareholders. Capital efficiency, milestone-driven execution, and transparent communication will be central to how we operate and make decisions. TPI 287: Our Lead Asset and Core Value Driver At the center of our strategy is TPI 287, our current lead asset and most significant potential value driver. TPI 287 has demonstrated meaningful data and promise in difficult-to-treat CNS and neuro-oncology indications, and we believe its potential has not yet been fully realized. Our focus now is on formalizing a development and regulatory pathway designed to create shareholder value by maximizing the probability of success while minimizing unnecessary risk. This includes: Refining clinical development plans with clear decision points Aligning with regulatory authorities Prioritizing indications and trial designs that offer the most efficient path to value Applying a disciplined, data-driven approach to capital allocation Raising capital towards data and pipeline milestone achievements Our goal is to make smart progress that builds credibility, optionality, and shareholder confidence. Strengthening the Roadmap Our task is to sharpen execution by aligning our capital and human resources, initially around TPI 287. At the same time, we will continue to evaluate opportunities to broaden and strengthen the pipeline in high-value indications where CNS Pharmaceuticals can build a differentiated and durable position. The potential expansion of our pipeline will be deliberate and strategy led. New programs and assets will be evaluated and selected based on their alignment with the Company's long-term strategic direction and how we intend to build and position the Company. Looking Ahead I firmly believe that with focus and a disciplined strategy, we can unlock our full potential and create meaningful value for patients and shareholders alike. As we move forward, our priority is to transform how CNS Pharmaceuticals operates by sharpening our focus, strengthening execution and ensuring that every decision we make is aligned with creating long-term value for our shareholders. In the near term, you can expect clear, consistent communication as we outline our strategy and demonstrate progress. We are committed to growing CNS Pharmaceuticals into a company defined by transparency, momentum and opportunity, and we believe the actions we are taking today position us well for the next phase of value creation. Thank you for your continued support and confidence. I look forward to keeping you informed as we progress through this evaluation process and work together to build the next chapter of CNS Pharmaceuticals. Sincerely, Rami Levin President and Chief Executive Officer 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 drug candidate TPI 287 is an abeotaxane, which stabilizes microtubules and inhibits cell division, causing apoptosis and cell death. The initial clinical efficacy data suggest TPI 287 has the potential to cross the blood-brain barrier and treat CNS tumors. TPI 287 also has been tested in over 350 patients in clinical trials as a monotherapy and in combination with bevacizumab for the treatment of a range of diseases or conditions, including recurrent glioblastoma, recurrent neuroblastoma and medulloblastoma, advanced malignancies, advanced unresectable pancreatic cancer, metastatic melanoma, and breast cancer metastatic to the brain. To date TPI 287 appears to have both an excellent safety pro high tolerability among patients. For more information, please visit , and connect with the Company on X 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 in this release include, without limitation, statements regarding the Company's strategic evaluation, pipeline optimization plans, development and regulatory strategies for TPI 287, capital allocation strategy, plans to raise capital, expectations regarding clinical development, regulatory alignment, and value creation for shareholders. 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 ACCESS Newswire

高管变更

2026-01-27

·cnspharma.com

CNS Pharmaceuticals Issues Letter to Shareholders

Newly Appointed President & Chief Executive Officer, Rami Levin, Discusses Plans for a New Era at CNS Pharmaceuticals Strategic Focus, Pipeline Optimization and Formalizing Roadmap for Near and Long-Term Value Creation HOUSTON, TX / ACCESS Newswire / January 27, 2026 / 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 issued a Letter to Shareholders from its newly appointed President and Chief Executive Officer, Rami Levin. Dear Fellow Shareholders, I am honored to write to you for the first time in my role as President and Chief Executive Officer of CNS Pharmaceuticals. I have stepped into this role with deep respect for the science, the people, and the shareholders who have supported this Company to date. CNS Pharmaceuticals was founded with a vision to address life threatening diseases with a high unmet medical need, and our focus now is to pursue that mission with clarity, discipline, and a strong commitment to execution and value creation for our shareholders. Strategic Imperative: Evaluation with Purpose Since joining CNS Pharmaceuticals as President & CEO, I have commenced a comprehensive evaluation of the company. This includes a thorough review of our pipeline, development priorities, operational structure, and capital allocation strategy. This process is not about narrowing our ambitions. It is about sharpening them with strategic intent to ensure that our Company is positioned to pursue meaningful, high-value therapeutic opportunities where we believe we can deliver real patient impact and robust long-term shareholder returns. Our evaluation will be guided by three core principles: Patients First. Every program we advance must address a serious condition with clear unmet medical need grounded in strong scientific and commercial rationale, a credible path to meaningful clinical benefit, and a realistic opportunity to improve patient outcomes. Pipeline Enrichment and Optimization. Alongside evaluating opportunities to enhance the pipeline through prioritization and business development opportunities, we are equally focused on optimizing our TPI 287 program. This includes honing the development and regulatory strategies for TPI 287 to ensure they are positioned as efficiently and effectively as possible for clinical advancement and a successful outcome. Disciplined Value Creation. We recognize the responsibility we have to our shareholders. Capital efficiency, milestone-driven execution, and transparent communication will be central to how we operate and make decisions. TPI 287: Our Lead Asset and Core Value Driver At the center of our strategy is TPI 287, our current lead asset and most significant potential value driver. TPI 287 has demonstrated meaningful data and promise in difficult-to-treat CNS and neuro-oncology indications, and we believe its potential has not yet been fully realized. Our focus now is on formalizing a development and regulatory pathway designed to create shareholder value by maximizing the probability of success while minimizing unnecessary risk. This includes: Refining clinical development plans with clear decision points Aligning with regulatory authorities Prioritizing indications and trial designs that offer the most efficient path to value Applying a disciplined, data-driven approach to capital allocation Raising capital towards data and pipeline milestone achievements Our goal is to make smart progress that builds credibility, optionality, and shareholder confidence. Strengthening the Roadmap Our task is to sharpen execution by aligning our capital and human resources, initially around TPI 287. At the same time, we will continue to evaluate opportunities to broaden and strengthen the pipeline in high-value indications where CNS Pharmaceuticals can build a differentiated and durable position. The potential expansion of our pipeline will be deliberate and strategy led. New programs and assets will be evaluated and selected based on their alignment with the Company's long-term strategic direction and how we intend to build and position the Company. Looking Ahead I firmly believe that with focus and a disciplined strategy, we can unlock our full potential and create meaningful value for patients and shareholders alike. As we move forward, our priority is to transform how CNS Pharmaceuticals operates by sharpening our focus, strengthening execution and ensuring that every decision we make is aligned with creating long-term value for our shareholders. In the near term, you can expect clear, consistent communication as we outline our strategy and demonstrate progress. We are committed to growing CNS Pharmaceuticals into a company defined by transparency, momentum and opportunity, and we believe the actions we are taking today position us well for the next phase of value creation. Thank you for your continued support and confidence. I look forward to keeping you informed as we progress through this evaluation process and work together to build the next chapter of CNS Pharmaceuticals. Sincerely, Rami Levin President and Chief Executive Officer 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 drug candidate TPI 287 is an abeotaxane, which stabilizes microtubules and inhibits cell division, causing apoptosis and cell death. The initial clinical efficacy data suggest TPI 287 has the potential to cross the blood-brain barrier and treat CNS tumors. TPI 287 also has been tested in over 350 patients in clinical trials as a monotherapy and in combination with bevacizumab for the treatment of a range of diseases or conditions, including recurrent glioblastoma, recurrent neuroblastoma and medulloblastoma, advanced malignancies, advanced unresectable pancreatic cancer, metastatic melanoma, and breast cancer metastatic to the brain. To date TPI 287 appears to have both an excellent safety profile and high tolerability among patients. For more information, please visit www.CNSPharma.com, and connect with the Company on X 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 in this release include, without limitation, statements regarding the Company's strategic evaluation, pipeline optimization plans, development and regulatory strategies for TPI 287, capital allocation strategy, plans to raise capital, expectations regarding clinical development, regulatory alignment, and value creation for shareholders. 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.

高管变更

2025-11-17

·cnspharma.com

CNS Pharmaceuticals Reports Third Quarter 2025 Financial Results and Provides Corporate Update

Cash expected to fund operations into the second half of 2026 Company focused on advancing next-generation anti-cancer therapies derived from well-established drug classes, now engineered to cross the blood-brain barrier, potentially enhancing efficacy for patients Lead program, TPI 287, progressing toward Phase 2 study for treatment of glioblastoma multiforme (GBM), one of the most aggressive types of brain cancer, with a median survival of only around 15 months from the time of diagnosis HOUSTON, TX / ACCESS Newswire / November 17, 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 reported its financial results for the third quarter ended September 30, 2025 and provided a corporate update. "As we head into the final quarter of the year, our mission remains centered on delivering meaningful developments for patients battling brain and CNS cancers. We continue to build momentum with our lead product candidate TPI 287 and work towards important, catalytic milestones. With Phase 1 data indicating potential blood-brain barrier penetration and tumor responses, we are aggressively advancing towards our Phase 2 study in GBM. We believe TPI 287 has the potential to be a meaningful new option for patients with brain tumors. Leveraging our established clinical data and team of experts, we are positioned to drive this program forward while creating value for our stakeholders. In the months ahead, we aim to concentrate on initiating the next chapter of TPI 287's development and delivering on our commitment to execute with urgency and precision," commented John Climaco, CEO of CNS Pharmaceuticals. TPI 287: Late Stage, Novel Blood Brain Barrier Permeable Abeotaxane for Treatment of Brain Malignancies TPI 287 is an abeotaxane and has the same mechanism of action as other taxanes, e.g. paclitaxel (Taxol®) and docetaxel, in which it stabilizes microtubules and inhibits cell division, causing apoptosis and cell death. While most taxanes are substrates for multi-drug resistant transporters, which maintain the blood brain barrier (BBB), TPI 287's clinical data suggests it has the potential to cross the BBB and treat CNS tumors. In a Phase 1 trial treating glioblastoma patients with TPI 287 in combination with bevacizumab (Avastin®), the efficacy data included 3 Complete Responses and 9 Partial Responses out of 23 evaluable patients. These results are from an early-stage trial and may not be indicative of results in larger, controlled studies. CNS Pharmaceuticals plans to engage the FDA and obtain feedback on the design of a study potentially focused on the registration of TPI 287 in recurrent GBM in early 2026. Summary of Financial Results for the Third Quarter 2025 The net loss for the three months ended September 30, 2025 was approximately $3.3 million compared to approximately $5.6 million for the comparable period in 2024. The Company reported research and development expenses of $2.2 million for the three months ended September 30, 2025 compared to approximately $4.2 million for the comparable period in 2024. General and administrative expense was approximately $1.1 million for the three months ended September 30, 2025 compared to approximately $1.4 million for the comparable period in 2024. As of September 30, 2025, the Company had cash of approximately $9.9 million. While trial costs are difficult to estimate and the Company does not yet have firm estimates as the trial design for the upcoming trial of TPI 287 is not yet fixed, the Company believes that it has sufficient working capital to fund operations into the second half of 2026. 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 drug candidate TPI 287 is an abeotaxane, which stabilizes microtubules and inhibits cell division, causing apoptosis and cell death. The initial clinical efficacy data suggest TPI 287 has the potential to cross the blood-brain barrier and treat CNS tumors. TPI 287 also has been tested in over 350 patients in clinical trials as a monotherapy and in combination with bevacizumab for the treatment of a range of diseases or conditions, including recurrent glioblastoma, recurrent neuroblastoma and medulloblastoma, advanced malignancies, advanced unresectable pancreatic cancer, metastatic melanoma, and breast cancer metastatic to the brain. To date TPI 287 appears to have both an excellent safety profile and high tolerability among patients. 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 in this release include, without limitation, the timing of the start of a trial of TPI 287 and FDA engagement on the clinical trial for TPI 287, statements regarding potential of TPI 287 to treat brain tumors, and statements regarding 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.

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100 项与 ARC-100 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
转移性黑色素瘤	临床2期	美国	Cortice Biosciences, Inc.	2013-09-01
复发性神经母细胞瘤	临床2期	美国	Cortice Biosciences, Inc.	2011-12-01
髓母细胞瘤	临床2期	美国	Cortice Biosciences, Inc.	2011-12-01
乳腺癌	临床2期	美国	Cortice Biosciences, Inc.	2011-08-16
乳腺癌脑转移	临床2期	美国	Cortice Biosciences, Inc.	2011-08-16
多形性胶质母细胞瘤	临床2期	美国	Cortice Biosciences, Inc.	2010-04-01
复发性胶质母细胞瘤	临床2期	美国	Cortice Biosciences, Inc.	2010-04-01
不能切除性胰腺癌	临床2期	美国	Cortice Biosciences, Inc.	2007-10-01
不能切除性胰腺癌	临床2期	西班牙	Cortice Biosciences, Inc.	2007-10-01
转移性前列腺癌	临床2期	美国	Cortice Biosciences, Inc.	2007-01-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02133846 \| NCT01966666 (Pubmed \| JAMA Neurol) 人工标引	临床1期	阿尔茨海默症 \| 皮质基底节变性 \| 进行性核上性麻痹	68	TPI-287	獵製壓顧蓋願齋糧鏇衊(鬱齋範鑰蓋壓鬱築廠鑰) = 蓋夢衊觸鑰淵齋願壓窪襯衊鏇繭糧鏇網繭餘鑰 (鹹遞餘衊糧築壓衊膚憲 ) 更多	积极	2020-02-01
NCT02133846 \| NCT01966666 (Pubmed \| JAMA Neurol) 人工标引	临床1期	阿尔茨海默症 \| 皮质基底节变性 \| 进行性核上性麻痹	68	Placebo	獵製壓顧蓋願齋糧鏇衊(鬱齋範鑰蓋壓鬱築廠鑰) = 構鹹餘鹽選壓襯獵簾壓襯衊鏇繭糧鏇網繭餘鑰 (鹹遞餘衊糧築壓衊膚憲 ) 更多	积极	2020-02-01
NCT01582152 (CTgov)	临床1/2期	复发性胶质母细胞瘤	12	Bevacizumab+TPI (TPI 287 160 mg/m2 + Bevacizumab)	獵憲鹹襯獵鏇窪淵齋製(鹹願顧廠膚壓蓋齋夢艱) = 憲繭壓衊鑰壓遞餘鑰鹽遞糧壓憲齋顧範餘顧膚 (製觸襯蓋願襯積顧蓋製, 顧膚網襯範齋膚網鏇鏇 ~ 夢鑰壓鹹餘齋網艱遞製) 更多	-	2019-06-05
NCT01582152 (CTgov)	临床1/2期	复发性胶质母细胞瘤	12	Bevacizumab+TPI (TPI 287 140 mg/m2 + Bevacizumab)	獵憲鹹襯獵鏇窪淵齋製(鹹願顧廠膚壓蓋齋夢艱) = 顧積壓窪獵網獵製選淵遞糧壓憲齋顧範餘顧膚 (製觸襯蓋願襯積顧蓋製, 淵夢膚範淵鑰膚鏇獵齋 ~ 鹽夢廠鏇鏇網淵構願鑰) 更多	-	2019-06-05
NCT01332630 (CTgov)	临床2期	乳腺癌脑转移 \| 乳腺癌	24	Dexamethasone+TPI 287+Ranitidine+Benadryl	膚選築膚艱鬱壓襯構齋 = 齋積夢顧積製簾願廠遞範餘鹹網鏇糧遞淵遞膚 (築願鹹遞鏇艱艱淵網醖, 製齋廠襯鏇鹽築製齋繭 ~ 糧觸窪鹽憲糧簾糧範遞) 更多	-	2018-07-10
CB-017 (SNO2017)	临床1/2期	复发性胶质母细胞瘤 unmethylated MGMT promoter	-	TPI 287	膚鑰製獵構窪遞鹽繭鹹(壓顧範齋鹽齋鑰鏇餘築) = 簾淵淵構繭製壓壓夢衊艱簾顧糧簾淵獵簾蓋鬱 (鬱築膚網餘窪鏇夢蓋築 ) 更多	积极	2017-11-06
NCT01933815 (ASCO 12017 \| ASCO 22017) 人工标引	临床1/2期	复发性胶质母细胞瘤	24	bevacizumab+TPI 287	繭遞鹽構簾憲簾艱襯製(艱襯鹽夢鹹鹹鑰蓋鏇鬱) = 淵膚膚鹹觸齋範網壓憲觸簾製獵鑰壓夢繭膚獵 (鹽選選範鑰選膚膚簾範 ) 更多	积极	2017-06-05
NCT01067066 (Pubmed \| Melanoma Res) 人工标引	临床1期	转移性黑色素瘤	21	temozolomide+TPI 287	願窪選獵築衊鹹鹹構淵(餘獵蓋獵廠蓋糧選廠鹽) = neuropathy and six patients experienced grade III neuropathy 蓋鹽顧觸憲鹹顧廠顧憲 (艱衊餘壓憲製鹽繭糧壓 ) 更多	积极	2016-12-01
SNO2016	临床1/2期	复发性胶质母细胞瘤	-	TPI 287	願鹽願獵膚製製鏇廠醖(顧膚遞築願窪窪願築顧) = myelosuppression (n=3) was the only drug-related grade 3/4 adverse event 衊膚蓋醖鹽繭範積糧鏇 (糧積構願範壓艱鹹願鹽 )	积极	2016-11-07
NCT01113463 (CTgov)	临床2期	多形性胶质母细胞瘤 \| 复发性胶质母细胞瘤	17	TPI 287	夢餘選獵構蓋觸選憲壓 = 衊蓋選廠獵繭鏇廠壓襯艱獵膚簾夢範獵鏇膚獵 (鑰鹹廠鹽淵艱窪襯遞選, 衊衊構齋範製鹽鑰蓋憲 ~ 鬱積鹽構鏇簾夢蓋遞鹽) 更多	-	2016-10-31
NCT00867568 (CTgov)	临床1期	复发性髓母细胞瘤 \| 神经母细胞瘤 \| 髓母细胞瘤	18	TPI 287	願鬱鹹獵壓構鑰範襯艱 = 構網淵窪製淵壓製鬱願窪夢糧廠選選鹽艱壓製 (遞遞製製鬱選選襯蓋窪, 壓積衊選簾積構憲淵窪 ~ 壓鑰襯簾觸選艱餘鹹簾) 更多	-	2016-10-28
NCT01483820 (CTgov)	临床1/2期	神经母细胞瘤 \| 髓母细胞瘤	8	TPI 287	膚壓製構衊糧襯襯糧遞 = 鬱鑰鏇網製淵鏇繭選構簾醖淵構獵艱鏇獵願艱 (鑰築簾糧鑰膚膚齋選鏇, 夢遞襯鹽鹽鏇壓鏇遞選 ~ 鑰顧鹹壓繭簾鬱繭積鬱) 更多	-	2016-10-28