A Phase 1, Multicenter, Open-label, Dose Escalation Study of the Safety and Pharmacokinetics of Intravenously Infused Berubicin in Pediatric Patients With Progressive, Refractory, or Recurrent High Grade Gliomas

This is a Phase 1, multicenter, open-label, dose escalation study of intravenous Berubicin in pediatric patients. The purpose of this first-in-pediatrics study is to examine the safety, tolerability, and PK of Berubicin and to estimate its MTD and/or RP2D when administered to pediatric patients with progressive, refractory, or recurrent HGG who have completed at least 1 standard line of therapy. This study will also make a preliminary assessment of the antitumor activity of Berubicin in this patient population. An exploratory evaluation of quality of life will also be performed

Start Date01 Dec 2023

Sponsor / Collaborator

WPD Pharmaceuticals Sp zoo

[+1]

NCT04915404

/ TerminatedPhase 1/2

A Multicenter, Open-Label Study of the Efficacy, Safety, and Pharmacokinetics of Intravenously Infused Berubicin in Adult Patients With Recurrent Glioblastoma Multiforme (WHO Grade IV) After Failure of Standard First Line Therapy

This is a multicenter, open-label, Phase 1b/2 efficacy and safety study of Berubicin utilizing a Simon's 2-stage design to confirm the efficacy (or futility) of a single arm of Berubicin treatment, administered at the recommended Phase 2 dose (RP2D) identified in Phase 1 studies (7.5 mg/m2 Berubicin HCl), on the endpoint of ORR in up to approximately 61 patients. A central reader will determine the radiologic responses for each patient according to m RANO criteria. The responder criteria for this Simon's design will be based on objective response criteria defined as individual patients achieving CR or PR per m-RANO criteria within 6 months from baseline.

Start Date07 Dec 2022

Sponsor / Collaborator

WPD Pharmaceuticals Sp zoo

[+2]

EUCTR2021-006028-41-PL

/ Not yet recruitingPhase 1/2IIT

Evaluation of the safety and efficacy of Berubicin in the treatment of central nervous system lymphomas- BERUBICIN - BERUBICIN

Start Date21 Feb 2022

Sponsor / Collaborator

Pomorski Uniwersytet Medyczny W Szczecinie

100 Clinical Results associated with Berubicin Hydrochloride

100 Translational Medicine associated with Berubicin Hydrochloride

100 Patents (Medical) associated with Berubicin Hydrochloride

Literatures (Medical) associated with Berubicin Hydrochloride

04 Jul 2024·JOURNAL OF PHYSICAL CHEMISTRY B

Interactions of a Novel Anthracycline with Oligonucleotide DNA and Cyclodextrins in an Aqueous Environment

Article

Author: Theodorou, Doros N ; Mikaelian, Georgios ; Megariotis, Grigorios

Berubicin, a chemotherapy medication belonging to the class of anthracyclines, is simulated in double-stranded DNA sequences and cyclodextrins in an aqueous environment via full-atom molecular dynamics simulations on the time scale of microseconds. The drug is studied in both the neutral and protonated states so as to better comprehend the role of its charge in the formed complexes. The noncovalent berubicin-DNA and berubicin-cyclodextrin complexes are investigated in detail, paying special attention to their thermodynamic description by employing the double decoupling method, the solvent balance method, the weighted solvent accessible surface model, and the linear interaction energy method. A novel approach for extracting the desolvation thermodynamics of the binding process is also presented. Both the binding and desolvation Gibbs energies are decomposed into entropic and enthalpic contributions so as to elucidate the nature of complexation and its driving forces. 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.

01 Dec 2014·Journal of neuroimmunologyQ3 · MEDICINE

Therapeutic targets in subependymoma

Q3 · MEDICINE

Article

Author: Liebelt, Brandon D ; Fuller, Gregory N ; Haider, Ali S ; Sawaya, Raymond ; Conrad, Charles A ; Ling, Xiaoyang ; Kong, Ling-Yuan ; Priebe, Waldemar ; Wei, Jun ; Heimberger, Amy B ; Levine, Nicholas B

Subependymomas are usually treated with surgical resection; however, no standard, defined alternative medical therapy is recommended for patients who are not surgical candidates, owing to a paucity of molecular, immunological, and genetic characterization. To address this, an ex vivo functional analysis of the immune microenvironment in subependymoma was conducted, a subependymoma cytokine/chemokine microarray was constructed for the evaluation of operational immune and molecular pathways, and a subependymoma cell line was derived and used to test a variety of cytotoxic agents that target operational pathways identified in subependymoma. We found that immune effectors are detectable within the microenvironment of subependymoma; however, marked immune suppression is not observed. The subependymoma tissue microarrays demonstrated tumor expression of p53, MDM2, HIF-1α, topoisomerase II-β, p-STAT3, and nucleolin, but not EGFRvIII, EphA2, IL-13RA2, CMV, CTLA-4, FoxP3, PD-1, PD-L1, EGFR, PDGF-α, PDGF-β, PDGFR-α, PDGFR-β, PTEN, IGFBP2, PI3K, MDM4, IDH1, mTOR, or Jak2. A topoisomerase inhibitor (WP744, IC50=0.83 μM) and a p-STAT3/HIF-1α inhibitor (WP1066, IC50=3.15 μM) demonstrated a growth inhibition of the subependymoma cell proliferation. Cumulatively, these data suggest that those agents that interfere with oncogenes operational in subependymoma may have clinical impact.

01 Apr 2007·Investigational new drugsQ3 · MEDICINE

The 4′-O-benzylated doxorubicin analog WP744 overcomes resistance mediated by P-glycoprotein, multidrug resistance protein and breast cancer resistance protein in cell lines and acute myeloid leukemia cells

Q3 · MEDICINE

Article

Author: Ralph J. Bernacki ; Hans Minderman ; Waldemar Priebe ; Tracy A. Brooks ; Brian N. Bundy ; Kieran L. O’Loughlin ; Michael R. Vredenburg ; Maria R. Baer ; Laurie A. Ford

BACKGROUND:

The synthetic 4'-O-benzylated doxorubicin analog WP744 was designed to abrogate transport by the multidrug resistance (MDR)-associated ATP-binding cassette (ABC) proteins P-glycoprotein (Pgp) and multidrug resistance protein (MRP-1). We compared its uptake and cytotoxicity with those of doxorubicin and daunorubicin in cell lines overexpressing Pgp, MRP-1 or breast cancer resistance protein (BCRP) and in acute myeloid leukemia (AML) cells.

METHODS:

Cellular uptake was studied by flow cytometry and cytotoxicity in 96-h 96-well cultures in cell lines overexpressing Pgp, MRP-1 or wild type (BCRP(R482)) or mutant (BCRP(R482T), BCRP(R482G)) BCRP and in pre-treatment AML marrow cells.

RESULTS:

Uptake and cytotoxicity of WP744 were consistently greater than those of doxorubicin and daunorubicin at equimolar concentrations in all cell lines studied and in AML cells.

CONCLUSION:

WP744 overcomes transport by Pgp, MRP-1 and BCRP in cell lines and AML cells and is a promising agent for clinical development in AML and other malignancies with broad-spectrum multidrug resistance.

News (Medical) associated with Berubicin Hydrochloride

13 Mar 2025

·www.biospace.com

Houston’s Life Sciences Scene Continues Boosting Its Reputation

Houston downtown park and skyline in the morning / iStock, Sean Pavone While Houston isn’t yet on the same level as major life sciences hubs, it has plenty to offer and room to grow, according to CNS Pharmaceuticals, RadioMedix and Greater Houston Partnership executives. As an emerging life sciences hub within the Lone Star Bio hotbed , Houston has made a name for itself in multiple ways. It’s known for its work not only in oncology but also in cell and gene therapy and medical devices, noted Verena Kallhoff, senior director of global life sciences at the Greater Houston Partnership. “It’s an incredibly vibrant life sciences ecosystem,” Kallhoff told BioSpace . “Lots of organizations that are playing in it are helping startups become successful, helping medium-sized companies mature. So, lots of activity, but we are a large region, and so that sometimes leads to it not being as well recognized because it’s not quite as concentrated as us being all around one square.” Houston probably needs to be more on the radar screen, said Ebrahim Delpassand, CEO, co-founder and chairman of RadioMedix . The clinical-stage biotech based in Houston develops targeted radiopharmaceuticals for cancer diagnosis, monitoring and therapy. “All of the ingredients that are needed for having a successful biotechnology company exist in Houston,” Delpassand told BioSpace . “We just need to spread the word.” Houston has more than 1,100 established life sciences and biotechnology companies, according to the Greater Houston Partnership. Kallhoff said hundreds of life sciences startups have emerged out of the city’s ecosystem, and many companies from across the globe have come there to advance their technologies. What people might not know about Houston’s life sciences scene, according to Kallhoff, is that it can provide a full pathway for bringing drugs to market. She noted that the city has strong research institutions like The University of Texas MD Anderson Cancer Center, Baylor College of Medicine and Rice University as well as accelerators, incubators and initiatives that help researchers explore how they can move from discovery to commercialization. Proximity to Texas Medical Center and MD Anderson There are multiple advantages to being in Houston, according to Delpassand, Kallhoff and John Climaco, CEO of CNS Pharmaceuticals , a clinical-stage biopharma based in Houston. One of the most significant, according to Delpassand and Kallhoff, is proximity to the world’s largest medical complex, the Texas Medical Center. The center is home to dozens of institutions, including MD Anderson, Baylor and Rice. Climaco cited proximity to MD Anderson as an advantage for companies like CNS, which is developing a pipeline of anti-cancer drug candidates. “If you’re in the oncology world, that’s the gold standard anywhere in the world,” Climaco told BioSpace about MD Anderson, which has the largest cancer clinical trials program. It had 1,556 trials in fiscal year 2024 . Having a relationship with MD Anderson is also an advantage for life sciences companies in Houston, according to Climaco. CNS itself has strong ties to the cancer center. Waldemar Priebe, a professor of medicinal chemistry at MD Anderson, founded CNS in 2017. He developed Berubicin, a next-generation anthracycline that was the biopharma’s first drug, at the cancer center. Having a drug with ties to MD Anderson instantly makes people take companies seriously not just in Houston but around the world, according to Climaco. Venture-Friendly, Risk-Friendly Funding Environment Houston’s life sciences companies are in a good funding environment, according to Delpassand. He noted that such an environment is especially important for startups, using RadioMedix as an example. Delpassand shared that for the first few years of the biotech’s existence, he essentially funded the company himself. Then, in 2010, RadioMedix received $2.8 million from the Texas Emerging Technology Fund. Delpassand said the money helped the biotech at a critical time in multiple areas, including expanding its laboratories and hiring more scientists. Climaco noted that Texas has a good early-stage mindset when it comes to funding companies. “I think a lot of investors in Houston are used to being up and down and up and down, and it doesn’t scare them,” he said. “And that’s really important for biotech, because especially the last five years, it has been a seriously wild ride.” I think a lot of investors in Houston are used to being up and down and up and down, and it doesn’t scare them. And that’s really important for biotech, because especially the last five years, it has been a seriously wild ride. John Climaco, CEO of CNS Pharmaceuticals Houston is venture friendly and risk friendly, Climaco said. “It’s not running from risk,” he said. “It’s running toward risk.” While discussing funding opportunities for Houston’s life sciences companies, Kallhoff highlighted the Cancer Prevention and Research Institute of Texas. The $6 billion 20-year initiative dedicated to cancer research and prevention has awarded more than $3.7 billion in grants to research institutions and organizations in the state. Regarding other financial assistance opportunities, the Houston market received $930 million of National Institutes of Health funding in fiscal year 2023 and $180 million in venture capital funding in 2023, according to an April 2024 Colliers life sciences report . Tens of Thousands of Talented Professionals and Experts For companies seeking life sciences talent, Houston has much to offer given its medical schools and other educational institutions that train the future workforce, according to Delpassand. He noted that this is important because personnel is the most valuable asset for any business. The Houston market ranks No. 14 for life sciences total employment, with 27,500 employees, according to a March 2025 Cushman & Wakefield life sciences report . That report also projected the market’s 10-year life sciences employment growth rate at 76.5%. Climaco agreed with Delpassand about the value of Houston’s educational institutions, noting that they’re chock full of experts who can guide and consult with life sciences companies. For scientific advisers and board members specifically, there are tens of thousands of people in Houston that fit that bill, according to Climaco. “You don’t really find that kind of heavy concentration outside the other big hubs,” he said. Affordability for Companies and Their Employees When it comes to a company’s bottom line, Delpassand noted that Houston’s infrastructure costs, including for commercial real estate, are a valuable advantage for those who want to start a business in the city. The asking rent in Houston for the third quarter of 2024 was $47.53 per square foot on a triple net lease where tenants pay property taxes, building insurance and maintenance costs, according to a Transwestern report . That’s lower than rents for Boston ($57.65), San Diego ($52.85) and San Francisco ($61.96). Kallhoff agreed with Delpassand that the cost of doing business in Houston is beneficial. She noted that there’s cost-effective—and abundant—space across the region, whether that’s for wet labs or just desks. According to the Cushman & Wakefield report, Houston has 680,000 square feet of life sciences space under construction and 1.1 million square feet proposed. Houston’s cost of living is also noteworthy, according to Kallhoff and Delpassand. Delpassand said the fact that it’s not as high as in other big cities makes a difference when RadioMedix hires people. According to Salary.com, the cost of living in Houston is 5.4% lower than the national average, a stark contrast to major life sciences hubs Boston and San Francisco , where it’s 53.1% and 86.5% higher, respectively, than the national average. What Comes Next: Areas of Emphasis and More Growth Looking ahead for Houston’s life sciences scene, Kallhoff said oncology and neurology will be among the areas that are big in the next five years. Regarding neurology specifically, she noted that the Texas Legislature is considering setting up a dementia prevention and research institute similar to the Cancer Prevention and Research Institute of Texas. Robust dementia work is already happening at area research institutions, she said. Climaco expects Houston to grow quickly moving forward, although he noted that the life sciences industry is tough right now. When the market turns around, he predicted, the city will probably explode as a biotech hub. “It’s such a science-friendly place,” Climaco said. “And as I said, so much talent in academia for advisers and experts and developers of technology. It’s got a lot going for it.” Interested in more career insights?  Subscribe to  Career Insider  to receive our quarterly life sciences job market reports, career advice and more.

Drug Approval

05 Dec 2024

·www.accesswire.com

CNS Pharmaceuticals to Host Virtual Analyst & Investor Day on December 11, 2024

Live webcast discussion featuring internationally renowned Glioblastoma Multiforme (GBM) Key Opinion LeadersCompany committed to addressing the most aggressive type of brain cancer with an average survival of only 14 to 16 months after diagnosis and no cureRegister for the event here HOUSTON, TX / ACCESSWIRE / December 5, 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 it will host a Virtual Analyst & Investor Day on Wednesday, December 11th from 11:30 AM - 1:00 PM ET.For the event, John Climaco, Chief Executive Officer, Sandra Silberman, MD, PhD, Chief Medical Officer and Zena Muzyczenko, Vice President of Clinical Operations at CNS Pharmaceuticals will be joined by Key Opinion Leaders: Michael Weller, Prof. Dr. med. Director of Department, Department of Neurology, Universitatsspital, Zurich, Switzerland; Samuel Goldlust, MD, Board-certified and fellowship-trained neuro oncologist with Saint Luke's Cancer Specialists; and Erin Dunbar, MD founding physician of the Brain Tumor Center and Director of Neuro-Oncology at Piedmont Atlanta Hospital.As part of the event, the members of the CNS Pharmaceuticals management team and participating KOLs will discuss GBM and provide an overview of Berubicin and next steps for the clinical development program. Additionally, participants will discuss the Company's second asset, TPI 287, and its development and regulatory strategy moving forward.A live video webcast of the event will be available on the Events page of the Investors section of the Company's website (cnspharma.com). A webcast replay will be available two hours following the live presentation and will be accessible for 90 days.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.For more information, please visit www.CNSPharma.com, and connect with the Company on X, Facebook, and LinkedIn.Forward-Looking StatementsSome 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 ContactJTC Team, LLCJenene Thomas908.824.0775[email protected]SOURCE: CNS Pharmaceuticals, Inc.

04 Sep 2024

·www.biospace.com

CNS Pharmaceuticals to Present at the H.C. Wainwright 26th Annual Global Investment Conference

HOUSTON, TX / ACCESSWIRE / September 4, 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 that John Climaco, Chief Executive Officer of CNS Pharmaceuticals will present at the H.C. Wainwright 26 th Annual Global Investment Conference being held September 9-11, 2024 in New York, NY. In addition to the presentation, management will be available to participate in in-person one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information, please visit the conference website . A video webcast of the presentation will be accessible for viewing on-demand beginning on Monday, September 9, 2024, at 7:00 AM ET for those registered for the event and will be accessible on the Events page in the Investors section of the Company’s website ( cnspharma.com ). The webcast replay will be archived for 90 days following the event. 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. For more information, please visit , and connect with the Company on X , Facebook , and LinkedIn . CONTACTS: Investor Relations Contact JTC Team, LLC Jenene Thomas 833-475-8247 CNSP@jtcir.com SOURCE: CNS Pharmaceuticals, Inc. View the original press release on accesswire.com

100 Deals associated with Berubicin Hydrochloride

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KEGG	Wiki	ATC	Drug Bank
D08871	-	-	DB05920

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Glioblastoma Multiforme	Phase 2	United States	CNS Pharmaceuticals, Inc.	18 May 2021
Glioblastoma Multiforme	Phase 2	France	CNS Pharmaceuticals, Inc.	18 May 2021
Glioblastoma Multiforme	Phase 2	Italy	CNS Pharmaceuticals, Inc.	18 May 2021
Glioblastoma Multiforme	Phase 2	Spain	CNS Pharmaceuticals, Inc.	18 May 2021
Glioblastoma Multiforme	Phase 2	Switzerland	CNS Pharmaceuticals, Inc.	18 May 2021
Recurrent Glioblastoma	Phase 2	United States	CNS Pharmaceuticals, Inc.	18 May 2021
Recurrent Glioblastoma	Phase 2	France	CNS Pharmaceuticals, Inc.	18 May 2021
Recurrent Glioblastoma	Phase 2	Italy	CNS Pharmaceuticals, Inc.	18 May 2021
Recurrent Glioblastoma	Phase 2	Spain	CNS Pharmaceuticals, Inc.	18 May 2021
Recurrent Glioblastoma	Phase 2	Switzerland	CNS Pharmaceuticals, Inc.	18 May 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04762069 (CNS-201, Company_Website) Manual	Phase 2	Glioblastoma Multiforme	252	Berubicin	boqmidnwts(pnemykvmrh) = uusifwzuwm tdrclqckma (jfubwwtdvk )	Positive	25 Nov 2024
				Lomustine	boqmidnwts(pnemykvmrh) = eqdmwsjpft tdrclqckma (jfubwwtdvk )
NCT04762069 (Biospace) Manual	Phase 1	Glioblastoma Multiforme First line	-	Berubicin	zbdhbwahye(rgpbnfroxx) = All reported adverse events for both arms are shown for all grades and grades 3-5. 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. lvhfxmfkgc (tznhbzipcn )	Positive	22 Nov 2023
				Lomustine
NCT04762069 (SNO2022) Manual	Phase 2	Glioblastoma Multiforme Second line	31	Berubicin	suuafigpkw(xrbbdpcolr) = itoaqzmaby qudogstzeg (rsbogukpvx ) View more	Positive	14 Nov 2022
				Lomustine	suuafigpkw(xrbbdpcolr) = pznpdspeix qudogstzeg (rsbogukpvx ) View more
ASCO2012	Phase 1	Multiple Myeloma	-	Berubicin	yvtcijxkct(eooviipxqv) = olwkanzomd ftkvmcvnox (cuoylfeehe )	-	20 May 2012
				Doxorubicin	yvtcijxkct(eooviipxqv) = zoymtjofej ftkvmcvnox (cuoylfeehe )
AACR2008	Phase 1	Brain Cancer	-	Berubicin	ieecvbbkuz(hhicayrotw) = gdrpucpkmz okakawvlru (czmxtghbvm ) View more	-	15 May 2008
ASCO2007	Phase 1	Brain Cancer	20	RTA 744	eikaylohlf(yavtnvbrqz) = a patient with GBM after seven cycles at 2.4 mg/m2/day sdxhqafqws (nugdfqkjvr ) View more	-	20 Jun 2007
ASCO2007	Phase 1	High grade glioma	20	RTA 744	yutasestrg(dqwasddhxv) = ttngdaxxjn gxbiauiftn (lxbdjorgcl ) View more	-	20 Jun 2007
ASCO2006	Phase 1	Glioma	-	RTA 744	pkmjrlvgvk(wllbyycrlv) = qrevokfavo vhrjihyqrf (cukzxnfzvu )	-	20 Jun 2006
				Temozolomide	pkmjrlvgvk(wllbyycrlv) = lmfurbxbpf vhrjihyqrf (cukzxnfzvu )

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