A Randomized Open-Label, Multi-Center Pivotal Study of ANG1005 Compared With Physician's Best Choice in HER2-Negative Breast Cancer Patients With Newly Diagnosed Leptomeningeal Carcinomatosis and Previously Treated Brain Metastases (ANGLeD)

This is an open-label Phase 3 study to see if ANG1005 can prolong survival compared to a Physician Best Choice control in HER2-negative breast cancer patients with newly diagnosed leptomeningeal disease and previously treated brain metastases.

Start Date01 Dec 2023

Sponsor / Collaborator

Angiochem, Inc.

ChiCTR2200063734 / SuspendedPhase 2/3IIT

A Multi-Center, Randomized, Controlled, Open-Label Study of SNG1005 Compared with Physician’s Best Choice in HER2-Negative Breast Cancer Patients with Newly Diagnosed Leptomeningeal Carcinomatosis and Previously Treated Brain Metastases

Start Date15 Sep 2022

Sponsor / Collaborator-

CTR20191654 / RecruitingPhase 3

SNG1005对比研究者选择单药化疗治疗既往全脑放疗后脑实质进展的HER2阴性BCBM患者的多中心、随机对照、开放标签临床试验

[Translation] A multicenter, randomized, controlled, open-label clinical trial of SNG1005 versus investigator's choice of chemotherapy alone in patients with HER2-negative BCBM who have progressed in the brain parenchyma after prior whole-brain radiotherapy

比较两组的总生存期（OS）；比较两组的颅内、颅外的无进展生存期（PFS）；比较两组颅内、颅外的客观缓解率（ORR）；比较两组的颅内缓解持续时间（DoR）和第3和6个月DCR；比较两组颅外DoR；比较两组整体QoL

[Translation]

Compare the overall survival (OS) between the two groups; Compare the intracranial and extracranial progression-free survival (PFS) between the two groups; Compare the intracranial and extracranial objective response rate (ORR) between the two groups; Compare the intracranial duration of response (DoR) and DCR at 3 and 6 months between the two groups; Compare the extracranial DoR between the two groups; Compare the overall QoL between the two groups

Start Date24 May 2022

Sponsor / Collaborator

Hong Kong Sinokang Pharmaceutical Technology Co., Ltd.

[+1]

100 Clinical Results associated with Paclitaxel trevatide

100 Translational Medicine associated with Paclitaxel trevatide

100 Patents (Medical) associated with Paclitaxel trevatide

118

Literatures (Medical) associated with Paclitaxel trevatide

01 Mar 2025·Biomaterials

Metal-organic framework-edaravone nanoparticles for radiotherapy-induced brain injury treatment

Article

Author: Zhong, Danni ; Hua, Shiyuan ; Ding, Zhongxiang ; Zhou, Min ; Li, Xuejiao

Cranial radiotherapy may cause damage to normal brain tissues and induce cognitive dysfunction, so developing an effective strategy to prevent radiotherapy-induced brain injury is essential. Metal-organic frameworks (MOFs) can be used as vectors for the delivery of neuroprotective drugs due to their high drug loading capacity and low toxicity. In this study, we synthesized MIL-53(Cr) nanoparticles, which were used to deliver edaravone, and modified the surface of the nanoparticles with polyethylene glycol and Angiopep-2 (EDA@MIL-53(Cr)-P/A) to improve their oral bioavailability and ability to cross the blood-brain barrier (BBB). We confirmed that MIL-53(Cr)-P/A nanoparticles could achieve the sustained release of edaravone and enhance its ability to cross the BBB. The results of in vitro experiments showed that EDA@MIL-53(Cr)-P/A could exert radioprotective effects on HT22 and BV2 cells. We also demonstrated that EDA@MIL-53(Cr)-P/A could alleviate brain injury and cognitive dysfunction in mice receiving whole-brain irradiation. Mechanistically, EDA@MIL-53(Cr)-P/A alleviated irradiation-induced brain damage by inhibiting oxidative stress, DNA damage, apoptosis and inflammatory reactions. This study provides a new strategy for the protection against radiotherapy-induced brain injury.

01 Dec 2024·Drug Delivery and Translational Research

Chemical engineering of zein with polyethylene glycol and Angiopep-2 to manufacture a brain-targeted docetaxel nanomedicine for glioblastoma treatment

Article

Author: Sarmento, Bruno ; Faria, Paulo ; Awad, Seem ; Araújo, Marco ; Martins, Cláudia

AbstractGlioblastoma (GBM) is the deadliest adult brain cancer. The current standard-of-care chemotherapy using orally administered temozolomide (TMZ) presents poor improvement in patient survival, emphasizing the compelling need for new therapies. A possible chemotherapeutic alternative is docetaxel (DTX), which possesses higher tumoricidal potency against GBM cells. However, its limited blood-brain barrier (BBB) permeability poses a constraint on its application. Nonetheless, nanomedicine offers promising avenues for overcoming this challenge. Angiopep-2 (ANG2) is a peptide that targets the BBB-overexpressed low-density lipoprotein receptor (LDLR). In this work, we managed, for the first time, to employ a pioneering approach of covalently linking zein protein with polyethylene glycol (PEG) and ANG2 prior to its formulation into nanoparticles (ZNPs) with enhanced stability and LDLR-mediated brain targetability, respectively. Carbodiimide and click chemistry approaches were optimized, resulting in functional modification of zein with around 25% PEG, followed by functional modification of PEG with nearly 100% ANG2. DTX-loaded ZNPs presented 100 nm average size, indicating high suitability for BBB crossing through receptor-mediated transcytosis. ZNPs maintained the cytotoxic effect of the loaded DTX against GBM cells, while demonstrating a safe matrix against BBB cells. Importantly, these brain-targeted ZNPs showcased up to fourfold enhancement in blood-to-brain permeability in a BBB in vitro model, highlighting the potential of this novel approach of BBB targeting in significantly improving therapeutic outcomes for GBM patients. The versatility of the system and the possibility of significantly increasing drug concentration in the brain open the door to its future application in a wide range of other brain-related diseases.Graphical abstract

01 Sep 2024·Drug Resistance Updates

Framework nucleic acid-based nanoparticles enhance temozolomide sensitivity in glioblastoma

Article

Author: Wang, Yuankai ; Wang, Zhao ; Dong, Yaoyuan ; Zuo, Boming ; Lu, Jiankun ; Zhang, Chao ; Li, Xiaodie ; Zeng, Tianci ; Liu, Boyang ; Cao, Shuting ; Zuo, Huaqin ; Yue, Qu ; Zhong, Xiangyang ; Fu, Xin ; Zhao, Yan ; Guo, Hongbo ; Wang, Yue ; Shen, Yixiong ; Lan, Yufei ; Yang, Tao ; Zhang, Manqing ; Luo, Xin ; Xie, Xinyun

O⁶-methylguanine DNA methyltransferase (MGMT) is a crucial determinant of temozolomide (TMZ) sensitivity in patients with glioblastoma (GBM). The therapeutic potential of small interfering RNA (siRNA) targeting MGMT to enhance TMZ sensitivity has been hampered by serum nuclease degradation, off-target effects, poor accumulation at tumor sites, and low circulation in blood stream. In this study, we developed a framework nucleic acid-based nanoparticles (FNN), which is constructed from a six-helix DNA bundle, to encapsulate and protect siMGMT for improving TMZ sensitivity in GBM treatment. For better blood-brain barrier (BBB) penetration and GBM targeting, we conjugated Angiopep-2 (ANG) targeting modules to each end of the FNN. Nucleolin (NCL)-responsive locks were engineered along the sides of the six-helix DNA bundle, which safeguard siMGMT before tumor entry. Upon interaction with tumor-overexpressed NCL, these locks unlock, exposing siMGMT, this allows for effective suppression of MGMT, resulting in a significant improvement of TMZ therapeutic efficacy in GBM. This innovative strategy has the potential to transform the current treatment landscape for GBM.

News (Medical) associated with Paclitaxel trevatide

07 Dec 2023

·www.prnewswire.com

Leptomeningeal Disease Pipeline Insights: 2023 Analysis Reveals Advancements in Global Cancer Treatment Developments

DUBLIN, Dec. 7, 2023 /PRNewswire/ -- The "Leptomeningeal Disease - Pipeline Insight, 2023" report has been added to ResearchAndMarkets.com's offering. This comprehensive analysis provides an in-depth view of the ongoing developments and future prospects in the therapeutic landscape of Leptomeningeal Disease (LMD), a serious complication that results from cancer cells spreading to the cerebrospinal fluid (CSF). This report is an indispensable resource for anyone interested in the evolving market dynamics and the potential of emerging therapies confronting this challenging medical condition. Unveiling the Scope of Leptomeningeal Disease Research: The report delineates the concerted efforts by pharmaceutical companies and academic researchers who are at the forefront of offering novel solutions to improve the management and therapeutic outcomes of LMD. With a focus on over seven companies and seven pipeline drugs, the document offers a detailed assessment of clinical and nonclinical stage products along with a meticulous analysis of their mechanism of action, clinical studies, and development activities. Emerging Therapies Highlighted: The spotlight is cast on promising candidates like ANG1005 by Angiochem Inc, poised to make a significant impact in LMD treatment. This drug showcases a novel approach by leveraging mechanisms to traverse the blood-brain barrier (BBB)—a profound breakthrough. Moreover, Kazia Therapeutics' Paxalisib represents an innovative PI3K/AKT/mTOR pathway inhibitor in Phase I evaluation, demonstrating the continuous evolution of targeted therapy in this realm. Therapeutic Assessment by Varied Parameters: Detailed Leptomeningeal Disease commercial and clinical assessment. Therapeutics segmentation by product type, developmental stage, route of administration, and molecule type. In-depth analysis of late-stage (Phase III) products. Insights into pipeline development activities and strategic collaborations. The document sets forth a thorough analysis of the pipeline landscape, also evaluating therapies across different stages such as Phase II and I trials. It incorporates a granular examination of the therapies, stratifying them based on administration routes ranging from oral to intrathecal, and classifies them under small molecules, peptides, and other categories. Furthermore, it investigates the intricate details of the product development process, from collaborations, acquisitions, and mergers, to the vital designations granted to drugs in the pipeline. The "Leptomeningeal Disease -Pipeline Insight, 2023" report is a testament to the enduring commitment to equipping industry participants with the knowledge required to navigate the complex terrain of cancer-related central nervous system complications. As the medical community endeavors to improve the prognosis and quality of life for patients afflicted with LMD, such comprehensive research analyses become not just tools for enlightenment, but beacons of hope. For those seeking a thorough understanding of the perspectives and progress in the treatment of Leptomeningeal Disease, this report is an indispensable resource. Interested parties are encouraged to explore the depth of research and analysis presented, shedding light on the future trajectory of therapeutics in this critical field of oncology. Companies profiled in the report include: Angiochem Kazia Therapeutics Mustang Bio Y-mAbs Therapeutics Plus Therapeutics For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

Phase 1ASCOFast Track

28 Jul 2023

·www.pharmaceutical-technology.com

Gilead gains EC approval for metastatic breast cancer drug Trodelvy

Trodelvy is intended for use as a monotherapy to treat unresectable or metastatic HR)-positive, HER2-negative breast cancer. Credit: CI Photos / Shutterstock.com. Gilead Sciences has received approval from the European Commission (EC) for its antibody-drug conjugate Trodelvy (sacituzumab govitecan) for pre-treated hormone receptor (HR)-positive, HER2-negative metastatic breast cancer. Trodelvy will be used as a single agent to treat unresectable or metastatic HR-positive, HER2-negative breast cancer patients who have received endocrine-based therapy, and a minimum of two additional systemic therapies in the advanced setting. Recommended Reports Reports LOA and PTSR Model - Paclitaxel Trevatide in Metastatic Breast Cancer GlobalData Reports LOA and PTSR Model - Lasofoxifene Tartrate in Metastatic Breast Cancer GlobalData View all Companies Intelligence Gilead Sciences Inc C H M P INC View all The approval was granted after a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). It is based on data from the TROPiCS-02 study, which showed a statistically significant and clinically meaningful overall survival benefit of 3.2 months against comparator single-agent chemotherapy. The international multicentre, open-label, Phase III study assessed Trodelvy against physicians’ choice of chemotherapy in 543 cases of HR+/HER2- metastatic breast cancer previously treated with endocrine therapy, a CDK4/6 inhibitor and two to four lines of chemotherapy for metastatic disease. Gilead Oncology therapeutic area head and senior vice-president Bill Grossman stated: “Trodelvy could change the outlook for women with pre-treated HR+/HER2- metastatic breast cancer by replacing the standard-of-care chemotherapy that has been their only option for decades. “We look forward to working with European authorities to ensure access for these patients who need new treatment options.” Trodelvy has received approval in more than 40 countries and is currently undergoing regulatory reviews worldwide. It is approved to treat adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have undergone at least two prior systemic therapies, one of which was for metastatic disease. Trodelvy is also being developed to treat other TNBC and HR+/HER2- metastatic and adjuvant breast cancer patients.

Phase 3Drug ApprovalClinical ResultADC

13 Jul 2023

·www.pharmaceutical-technology.com

China approves AstraZeneca-Daiichi Sankyo’s breast cancer therapy

Enhertu is indicated for use in adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. Credit: Nephron / commons.wikimedia.org. The Chinese National Medical Products Administration has granted approval for AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) as a monotherapy to treat breast cancer. An antibody-drug conjugate (ADC) targeting the HER2 protein, Enhertu is indicated for use in adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. Recommended Reports Reports LOA and PTSR Model - Paclitaxel Trevatide in Metastatic Breast Cancer GlobalData Reports LOA and PTSR Model - Dovitinib Lactate in Breast Cancer GlobalData View all Companies Intelligence AstraZeneca Plc Daiichi Sankyo Co Ltd View all These patients should have received a previous systemic treatment in the metastatic setting, or have experienced a recurrence of the condition during or within six months of receiving adjuvant chemotherapy. The latest approval is based on data from Phase III DESTINY-Breast04 clinical trial. Trial data showed that the therapy reduced disease progression or the risk of death by half, and boosted median overall survival by more than six months compared with physician’s choice of chemotherapy. In February 2023, the ADC was approved for treating priorly treated unresectable or metastatic HER2-positive breast cancer . AstraZeneca oncology business unit executive vice-president Dave Fredrickson stated: “The results from the DESTINY-Breast04 trial show Enhertu provides a significant improvement in outcomes compared to chemotherapy for patients whose tumours are determined to be HER2-low via routine testing. “This approval is an important advance in the way breast cancer is classified and treated in China and supports our vision to bring Enhertu to more patients worldwide.”

ADCDrug ApprovalClinical ResultPhase 3

100 Deals associated with Paclitaxel trevatide

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Malignant Neoplasm to the Leptomeninges	Phase 3	-	Angiochem, Inc.	01 Dec 2023
HER2-negative breast cancer	Phase 3	CN	Hong Kong Sinokang Pharmaceutical Technology Co., Ltd.	12 Aug 2022
HER2-negative breast cancer	Phase 3	CN	Beijing Shenogen Pharma Group Ltd.	12 Aug 2022
Brain metastases	Phase 3	CN	Hong Kong Sinokang Pharmaceutical Technology Co., Ltd.	24 May 2022
Brain metastases	Phase 3	CN	Beijing Shenogen Pharma Group Ltd.	24 May 2022
HER2 Positive Breast Cancer	Phase 3	CN	Beijing Shenogen Pharma Group Ltd.	24 May 2022
HER2 Positive Breast Cancer	Phase 3	CN	Hong Kong Sinokang Pharmaceutical Technology Co., Ltd.	24 May 2022
Neoplasms	Phase 3	CA	Angiochem, Inc.	30 Jan 2022
Glioblastoma	Phase 3	-	Beijing Shenogen Pharma Group Ltd.	-
Glioblastoma	Phase 3	-	Angiochem, Inc.	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01497665 (GRABM-L, CTgov)	Phase 2	metastatic non-small cell lung cancer \| Brain metastases	16	GRN1005	srthsdsdje(ipiriwnjac) = tpoltzuzwv dhqyibidxu (cphhorewqn, rdxqkqpxfg - fvteuuyufl) View more	-	14 Dec 2015
NCT01480583 (ASCO2015)	Phase 2	Brain metastases	85	ANG1005	kwygensfgq(sjnqynuzeb) = ykzsuebshv ueinvrgtqg (yfhzdgwvog ) View more	-	20 May 2015
ASCO2010	Phase 1	Recurrent Malignant Glioma	63	ANG1005	(qihtiouakh) = nqzhrjkcgx vradljilbg (ackqxqczya )	Positive	20 May 2010

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