A Phase I/II Study to Evaluate Safety and Efficacy of the Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA As Boron Carrier in Recurrent Meningioma

This Phase I/II study, titled 'A Study to Evaluate the Safety and Efficacy of Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA as a Boron Carrier in Recurrent Meningioma', aims to assess the efficacy of B10 L-BPA with BNCT in patients with recurrent meningioma. The primary objective is to evaluate the safety and efficacy of BNCT with B10 L-BPA for recurrent meningioma treatment, using the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) as the standard for assessment.

Start Date14 Oct 2024

Sponsor / Collaborator-

JPRN-jRCT2031240246

/ SuspendedPhase 1/2IIT

Phase I/II basket trial: Boron Neutron Capture Therapy (BNCT) using CICS-1 and SPM-011 for patients with recurrent solid malignant thoracic tumors that are unresectable and perceived challenging to treat with standard treatment - SJ-BT001

Start Date31 Jul 2024

Sponsor / Collaborator-

ChiCTR2400082903

/ SuspendedPhase 1IIT

A Phase I study of safety, tolerability, pharmacokinetics, and efficacy of boron neutron capture therapy (BNCT) with NBB-001 and boron neutron capture therapy system in patients with recurrent head and neck malignancies

Start Date10 Apr 2024

Sponsor / Collaborator-

100 Clinical Results associated with Borofalan (10B)

100 Translational Medicine associated with Borofalan (10B)

100 Patents (Medical) associated with Borofalan (10B)

9,052

Literatures (Medical) associated with Borofalan (10B)

01 Jun 2025·Journal of Environmental Sciences

Facile synthesis of boron-doped porous biochar as a metal-free adsorbent for efficient removal of aqueous tetracycline antibiotics

Article

Author: Xu, Lu ; Qi, Yuetong ; Wang, Chengzhi ; Wang, Kai ; Jin, Xin ; He, Shaolei ; Wang, Qize ; Jin, Pengkang

This study introduced a microwave-assisted pyrolysis method for the rapid and efficient preparation of boron-doped porous biochar. The resulting biochar exhibited a large specific surface area (933.39 m²/g), a rich porous structure (1.044 cm³/g), and abundant active sites. Consequently, the prepared boron-doped porous biochar exhibited higher efficiency in adsorbing tetracycline with a maximum adsorption capacity of 413.223 mg/g, which significantly exceeded that of unmodified biochar and most commercial and reported adsorbents. The correlation analysis between the adsorption capacity and adsorbent characteristics revealed that the formation of the -BCO₂ group enhanced π-π electron donor-acceptor interactions between boron-doped porous biochar and tetracycline. This mechanism mainly contributed to the enhanced adsorption of tetracycline by boron-doped porous biochar. Additionally, the as-prepared boron-doped porous biochar exhibited broad applications in removing antibiotics (tetracycline), phenolics (bisphenol A), and dyes (methylene blue and rhodamine B). Moreover, the boron-doped porous biochar exhibited satisfactory stability, and its adsorption capacity can be nearly completely regenerated through simple heat treatment. This study provides new insights into the effectiveness of boron-doped carbonaceous materials in removing antibiotic contaminants.

01 May 2025·Journal of Environmental Sciences

Efficient activation of peroxymonosulfate for catalytic degradation of organic pollutants by simultaneously using low-level cobalt ions and calcium carbonate micro-particles

Article

Author: Zhou, Yu ; Wang, Xiaobo ; Huang, Shuangshuang ; Wang, Nan ; Zhu, Lihua

An efficient catalytic system was developed to remove various organic pollutants by simultaneously using low-level cobalt ions, calcium carbonate micro-particles and peroxymonosulfate (PMS). A simple base-induced precipitation was used to successfully loaded Co-centered reactive sites onto the surface of CaCO₃ microparticles. Under optimal conditions at 25 °C, 10 mg/L methylene blue (MB) could be completely degraded within 10 min with 480 µg/L Co²⁺, 0.4 g/L CaCO₃ microparticles (or 0.4 g/L Co@CaCO₃) and 0.1 g/L PMS. The MB degradation followed the pseudo first order kinetics with a rate constant of 0.583 min^-1, being 8.3, 11.5 and 53.0 times that by using Co-OH (0.07 min^-1), Co²⁺ (0.044 min^-1) and CaCO₃ (0.011 min^-1) as the catalyst, respectively. It was confirmed that there was a synergistic effect in the catalytic activity between Co species and the CaCO₃ particles but the major contributor was the highly dispersed Co species. When Co²⁺-containing simulated electroplating wastewater was used as the Co²⁺ source, not only the added MB was also completely degraded within 5 min in this catalytic system, but also the coexisting heavy metal ions were substantially removed. The presently developed method was applied to simultaneously treat organic wastewater and heavy metals wastewater. The present method was also successfully used to efficiently degrade other organic pollutants including bisphenol A, sulfamethoxazole, rhodamine B, tetrabromobisphenol A, ofloxacin and benzoic acid. A catalytic mechanism was proposed for the PMS activation by Co@CaCO₃. The surface of CaCO₃ particles favors the adsorption of Co²⁺. More importantly, the surface of CaCO₃ particles provides plentiful surface -OH and -CO₃²⁺, and these surface groups complex with Co²⁺ to produce more catalytically active species such as surface [CoOH]^-, resulting in rapid Co²⁺/Co³⁺ cycling and electron transfer. These interactions cause the observed synergistic effect between Co species and CaCO₃ particles in PMS activation. Due to good cycle stability, strong anti-interference ability and wide universality, the new method will have broad application prospects.

01 May 2025·Journal of Environmental Sciences

The effects of 17β-trenbolone and bisphenol A on sexual behavior and social dominance via the hypothalamic-pituitary-gonadal axis in male mice

Article

Author: Sun, Minghe ; Luan, Jialu ; Zhao, Qili ; Zhang, Shuhui ; Feng, Xizeng ; Bai, Huijuan ; Sun, Mingzhu ; Zhao, Xin ; Yu, Qian ; Fu, Zhenhua ; Zuo, Xiang

17β-Trenbolone (17-TB) is well documented as an environmental endocrine disruptor in aquatic biological studies, but its effects on mammals remain poorly understood. Furthermore, 17-TB acts as a hormone with properties similar to testosterone, and the consequences of juvenile exposure on adult social behavior remain uncertain. Bisphenol A (BPA) acts as an estrogen-like hormone, compared to 17-TB. Three-week-old male Balb/c mice were exposed orally to 17-TB (100 µg/(kg·day)) and BPA (4 mg/(kg·day)) for 28 days. Assessments of social interactions and a three-chamber test showed that 17-TB increased virility in male mice, intensified both male and female sexual behavior, and attracted and accepted female mice. It also increased social dominance through tube tests in male mice and markedly activated the c-Fos⁺ immune response in the medial prefrontal cortex (mPFC) and basal amygdala (BLA). ELISA data showed that 17-TB and BPA exposure significantly affected serum gonadotropin-releasing hormone (GnRH), growth hormone (GH), estradiol (E2), and luteinizing hormone (LH) levels, as well as testicular lesions and androgen receptor (ARβ) and estrogen receptor (ERα) synthesis. Testicular transcriptomic analysis further confirmed that could disrupt steroid synthesis and linoleic acid-related biometabolic processes. These findings suggest the influence of 17-TB and BPA exposure on sexual behavior and fertility in male mice, possibly through modulation of the hypothalamic-pituitary-gonadal axis. This study provides insights relevant to human reproductive health and neuro-social behavioral research, and the potential risk of environmental disturbances should not be overlooked.

News (Medical) associated with Borofalan (10B)

17 Dec 2024

·www.businesswire.com

TAE Life Sciences and CNAO Announce Definitive Agreement on BNCT, a Next-Generation Cancer Therapy

PAVIA, Italy--( BUSINESS WIRE )--TAE Life Sciences (TLS), a leading developer of Boron Neutron Capture Therapy (BNCT) systems and drugs, and the Italian National Center for Oncological Hadrontherapy (CNAO), a premier hadrontherapy center in Europe, today announced a definitive agreement to collaborate on groundbreaking global drug research and development initiatives for the implementation of BNCT. This strategic partnership will bring together the expertise of two innovative leaders in cancer treatment, with the purpose to revolutionize cancer care through BNCT, a targeted radiation therapy designed to improve outcomes for patients with complex and metastatic cancers. CNAO’s extensive experience in hadrontherapy, encompassing proton, carbon ions and other particles, complements TLS’s leadership in advancing cancer treatment with BNCT technology and drug development. BNCT is a type of combination cancer treatment that uses neutron radiation and a special boron compound to target and destroy cancer cells. The process involves two main steps. In the first one, a boron-rich compound is administered to the patient, typically via injection or infusion. This compound is designed to be selectively absorbed by cancer cells, with minimal uptake by normal tissues. In the second step, after the boron compound has been absorbed by the cancer cells, the patient is exposed to a beam of low-energy neutrons. These neutrons interact with the boron atoms within the cancer cells and destroy them. In late 2020, CNAO had already entered into an agreement with TLS to adopt the BNCT system and install an accelerator-based neutron source in Italy. Now, the new agreement completes the collaboration, including the drug development as well. Prof. Gianluca Vago , CNAO President, commented: “ Our mission has always been to leverage cutting-edge technologies to expand treatment opportunities for the benefit of cancer patients. Being chosen by TLS for such an important collaboration is a further recognition of CNAO's expertise in particle therapies, both in clinical and research activities. For this project, our center will work in close cooperation with University of Pavia, Polytechnic University of Milan, National Institute for Nuclear Physics and Fondazione IRCCS Policlinico San Matteo of Pavia. The partnership with TLS will enable us to open up new frontiers in BNCT and make CNAO a unique facility in the world to combine treatments with protons, heavy ions (carbon ions and other species) and neutrons.” Planned Milestones and Key Objectives: Installation and Clinical Trials: The installation of TLS’s Alphabeam ® BNCT system at CNAO is scheduled to begin in 2025, with clinical trials launching in 2026. The initial trials will leverage Steboronine ® (Boronophenylalanine, BPA)—an boron drug developed by Stella Pharma for BNCT and distributed by TLS in Europe and the US. Steboronine® selectively accumulates boron in cancer cells and is already approved in Japan for recurrent head and neck cancers, the focus of these first trials. Advancing Cancer Treatment: The collaboration is poised to expand the clinical applications of BNCT to address a wide range of cancers, including metastatic cancers, offering new hope for patients worldwide. CNAO NEXT Services: The partnership includes efforts to promote the range of services offered by CNAO NEXT, an independent company set up by CNAO, which operates in the field of precision therapies, providing technical and clinical consultancy and assisting other centers in implementing particle therapies. A significant aspect of the collaboration involves the clinical implementation and commercialization of new TLS BNCT drugs, such as Boronotyrosine (BTS), which has shown promising preclinical results in animal models. “ Our partnership with CNAO marks a transformative step in advancing BNCT as a next-generation cancer therapy,” said Rob Hill , CEO of TAE Life Sciences. “ Together, we aim to push the boundaries of cancer treatment and provide groundbreaking solutions to patients who need them most.” Additionally, prof. Lisa Licitra, Scientific Director of CNAO, Chief of Head and Neck Cancer Medical Oncology Dept at Fondazione IRCCS Istituto Nazionale dei Tumori, Associate Professor at the University of Milan, has joined the TLS Clinical Advisory Board as an internationally recognized leader in head and neck oncology. She will serve as leading oncologist for the BNCT clinical trials at CNAO focusing on head and neck cancer and will oversee the clinical trial at CNAO, further strengthening the collaboration’s scientific foundation. Prof. Lisa Licitra , Scientific Director of CNAO, affirmed: “ BNCT has demonstrated compelling responses for recurrent or refractory tumours, such as head and neck cancers. Therefore, working with Prof. Ester Orlandi, Head of CNAO Clinical Department, we will initially focus on patients with this type of tumours. With the introduction of BNCT, we can reduce treatment to 1-2 sessions, expand therapeutic indications and potentially offer new hope to patients with metastatic tumours. Our goal will be to offer increasingly customized therapeutic options, by having at our disposal a wide range of particles: not only protons and carbon ions but also neutrons for BNCT, helium and oxygen.” About TAE Life Sciences: TAE Life Sciences is a privately held biotechnology company committed to developing a new biologically targeted radiation therapy based on Boron Neutron Capture Therapy (BNCT). TAE Life Sciences is the only company developing the next-generation targeted boron drugs and low-energy accelerator-based neutron system optimized for an in-hospital BNCT program that delivers cancer-killing radiation with cellular-level precision to treat patients with aggressive and refractory cancers. TAE Life Sciences’ Alphabeam™ BNCT system and proprietary boronated drugs are still in the investigational stage, and not available commercially. More information about TAE Life Sciences is available at taelifesciences.com . About CNAO: The National Center for Oncological Hadrontherapy (CNAO), located in Pavia, Italy, is one of the only six centers in the world able to perform hadrontherapy with both protons and carbon ions and has treated about 5,500 oncological patients, working in the particle therapy field for 15 years. CNAO mission is to be at the forefront of providing cutting-edge cancer therapies with the goal of offering highly targeted, precision treatments for patients with complex and rare cancers. CNAO is dedicated to advancing research and clinical applications of hadrontherapy, making a significant contribution to the improvement of cancer care, also through the establishment of a network of national and international collaborations. More information about CNAO is available at https://fondazionecnao.it/en/ .

Radiation TherapyClinical StudyDrug Approval

14 Nov 2024

·www.businesswire.com

TAE Life Sciences and Stella Pharma Announce Strategic Agreement for Development and Commercialization of BPA for BNCT Cancer Therapy in the USA and Europe

IRVINE, Calif.--( BUSINESS WIRE )--TAE Life Sciences (TLS), a leader in developing boron neutron capture therapy (BNCT) technology and associated innovative boron target drugs, and Stella Pharma, the pioneering developer of boronophenylalanine (BPA) under the product name Steboronine® for BNCT, are pleased to announce a strategic collaboration focused on the development, commercialization and expansion of BNCT using BPA in the United States and European markets. Stella Pharma’s BPA drug is the world’s first and only clinically approved boron drug for BNCT, marking a breakthrough in cancer treatment. Japan became the first country to approve BNCT for the treatment of head and neck cancers, using Stella Pharma’s pioneering BPA drug. Now, Stella Pharma, as the leading producer and supplier of BPA, has joined forces with TAE Life Sciences to expand the adoption of BNCT worldwide. Supporting the Future of BNCT Therapy The collaboration objectives include extensive international cooperation in the development and commercialization of BNCT and BPA across the USA and Europe with clinical trials anticipated to begin in 2026. TLS will serve as the exclusive commercial partner for Stella Pharma’s BPA in these regions, representing a significant expansion of BNCT accessibility outside of Asia. “ Our partnership with Stella Pharma combines our shared commitment to advancing BNCT as a viable cancer treatment for patients worldwide,” said Rob Hill, CEO of TAE Life Sciences. “ We are excited to bring the proven benefits of BPA to U.S. and European healthcare institutions and to support BNCT globally with this powerful therapeutic solution.” Both companies have also committed to supporting BNCT equipment vendors across all markets in implementing BPA-based BNCT treatments. By fostering partnerships within the BNCT ecosystem, TLS and Stella Pharma aim to enhance the clinical reach of BNCT in treating recurrent head and neck cancers and advancing clinical studies for other cancers, including brain, skin, breast, esophagus, and lung cancers. “ Our alliance with TAE Life Sciences marks a significant step in expanding the reach of BPA-based BNCT treatments beyond Asia,” said Koki Uehara, President and Chief Operating Officer of Stella Pharma. “ We look forward to collaborating internationally to develop and commercialize BNCT and aim to deliver these advancing cancer treatments to patients and their families worldwide.” Exploring Future Opportunities Together Stella Pharma and TAE Life Sciences share a vision of advancing BNCT treatment for hard-to-treat cancers and pledge to explore additional areas for collaboration. Through this alliance, they seek to accelerate innovation, expand treatment options, and ultimately improve outcomes for cancer patients worldwide.

Drug Approval

21 Aug 2024

·www.drugs.com

Phenol, Paraben Exposure Linked to Hypertension During Pregnancy

WEDNESDAY, Aug. 21, 2024 -- Phenol and paraben exposure may be associated with hypertension during pregnancy, according to a study published online Aug. 14 in Environmental Health Perspectives . Julia R. Varshavsky, M.P.H., Ph.D., from the Bouvé College of Health Sciences at Northeastern University in Boston, and colleagues examined associations between individual phenols, parabens, and their mixture on maternal blood pressure (BP) measurements and hypertension during pregnancy among 1,433 women. The relationships were examined cross-sectionally at two time points during pregnancy (16 to 20 and 24 to 28 weeks of gestation) and longitudinally. The researchers found that exposure to multiple analytes and the overall mixture was associated with a trend toward higher odds of hypertension during pregnancy, especially at 24 to 28 weeks of gestation (adjusted mixture odds ratio, 1.57). Individual analytes were also associated with lower systolic BP (SBP) and higher diastolic BP (DBP), with the results from the linear mixed models most consistent for methyl paraben or propyl paraben with increased DBP (β = 0.78 and 0.85, respectively), and for bisphenol A, which was associated with lower SBP (β = −0.57). There was evidence of effect modification by fetal sex, with a strong inverse association between overall exposure mixture and SBP among those carrying female fetuses. "These everyday products that we think are safe may be actually harming us and our babies at a critical time during pregnancy," Varshavsky said in a statement. "In the largest study to date, we found that the combined effect of phenol and paraben mixtures increased risk of hypertension during pregnancy among a vulnerable population of women in Puerto Rico who are also dealing with a disproportionate burden of exposure to other toxic chemicals, poverty, and climate change-related disasters like hurricanes and flooding." Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical Result

100 Deals associated with Borofalan (10B)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XX	DB06973

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Head and Neck Neoplasms	JP	Stella Pharma Corp.	25 Mar 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Recurrent Head and Neck Carcinoma	Phase 1	CN	China Boron (Xiamen) Biopharmaceutical Co., Ltd.	01 Apr 2024
Advanced Head and Neck Squamous Cell Carcinoma	IND Approval	CN	Hainan Poly Pharm. Co., Ltd.	08 Feb 2025
Recurrent Squamous Cell Carcinoma of the Head and Neck	IND Approval	CN	Hainan Poly Pharm. Co., Ltd.	08 Feb 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ADA2024	Not Applicable	Hypersensitivity	-	Oral Bisphenol A Administration at 50 Î¼g/kg body weight	dcfqwlhhot(ounkoimqcc) = msetlipgem kaeusgknpc (pymdcahqza, 0.01)	-	21 Jun 2024
				Bisphenol A (Oral Placebo Administration)	dcfqwlhhot(ounkoimqcc) = oknkheoafa kaeusgknpc (pymdcahqza, 0.01)
UEGW2023	Not Applicable	Metabolic dysfunction-associated steatotic liver disease	-	BISPHENOL A (Healthy individuals)	ddwjriamvq(qqtjairbhm) = pzemysjyss aqzmbmaugf (jptusxxinf )	-	15 Oct 2023
				BISPHENOL A (NASH patients)	ddwjriamvq(qqtjairbhm) = bobzbjkrlu aqzmbmaugf (jptusxxinf )
ODP276 (ENDO2022)	Not Applicable	Thyroid Cancer	-	BISPHENOL-A (Nthy-ori 3-1 cells)	brjwfogzma(bdsbhcdinf) = mahujpveqc ubmdwtgmxs (ftspevtszd )	-	01 Nov 2022
				BISPHENOL-A (TPC-1 cells)	brjwfogzma(bdsbhcdinf) = dlfkaynsla ubmdwtgmxs (ftspevtszd )
EASD2021	Not Applicable	Insulinoma	-	Bisphenol-A (BPA) 1 μM	mhdmdgvnwm(wxjqbhbuia) = jfeodwnoah nqtqwqdhtj (jokbiiehyx )	Negative	28 Sep 2021
EASD2020	Not Applicable	-	-	bisphenol-A (3T3-L1 cells)	evbrmxnpcb(yboouuavhz) = not enhanced by BPA exposure fporobnuzj (cegfuauwkm ) View more	-	22 Sep 2020
				bisphenol-A (NIH-3T3 cells)
JPRN-JapicCTI-194640 (ESMO2019)	Phase 2	Recurrent Head and Neck Carcinoma \| Recurrent Squamous Cell Carcinoma of the Head and Neck	-	borofalan(10B) (SPM-011) (AB-BNCT with borofalan(10B))	wgnhmefkug(ppuanonfsg) = ifsykqemtm jdzcmfakuc (xwwobjhezn ) View more	-	30 Sep 2019
AAI2018	Not Applicable	Neutrophil Chemotactic Response, Abnormal	-	Bisphenol-A	nnpkstkdnf(tdxcirfxqf) = 4 to 6 day post fertilization (dpf) zebrafish exposed to environmentally relevant doses of BPA show reduced background expression of CXCL-8 zekbmbhhch (nrzffjlhjm ) View more	-	01 May 2018
ASN2017	Not Applicable	Bisphenol A (BPA)	-	Bisphenol A (BPA-free polynephron dialyzers)	xywjygrygu(elqjrxyexe) = cbsxkcuxnc lzoccbkcfw (aaebtjmfvn, 7.97)	Positive	31 Oct 2017
				Bisphenol A (BPA-containing polysulfone dialyzers)	xywjygrygu(elqjrxyexe) = gwtowwimwv lzoccbkcfw (aaebtjmfvn, 20.38)
SP491 (ERA2017)	Not Applicable	Bisphenol A (BPA)	58	Polinephron (PN)	wjdnfodrfa(kosudcqobv) = gdmttcusng acusabyvhw (azmtheilnt )	Positive	26 May 2017
				Bisphenol A (BPA) (Polysulphone (PS))	wjdnfodrfa(kosudcqobv) = vpislotsyg acusabyvhw (azmtheilnt )
FP520 (ERA2015)	Not Applicable	BPA	69	Polinephron (PN)	gccbcsjnfg(bpiflgzfiu) = mpcdjnirle dhbfcesnsm (czyrhqjlzv ) View more	Negative	21 May 2015
				Bisphenol A (BPA) (Polysulphone (PS))	rlofgyotkj(wprlgezyec) = utbqhwzrju mzeskleieb (jlcupmxsal ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Borofalan (10B)

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation