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

107

Literatures (Medical) associated with Paclitaxel trevatide

01 Jan 2024·Journal of controlled release : official journal of the Controlled Release Society

Simultaneous ischemic regions targeting and BBB crossing strategy to harness extracellular vesicles for therapeutic delivery in ischemic stroke

Article

Author: Cui, Guo-Hong ; Liang, Huai-Bin ; Tang, Yao-Hui ; Chen, Xiao ; Liu, Jian-Ren ; Li, Shen-Jie ; Zhao, Rong ; Huang, Pei-Sheng

Extracellular vesicles (EVs) derived from adipose-derived stem cells (ADSC-EVs) hold great promise for ischemic stroke treatment, but their therapeutic efficacy is greatly limited due to insufficient targeting ability. Previous reports focused on single ischemic targeting or blood-brain barrier (BBB) penetration, precise delivery to the brain parenchyma has not been fully considered. This study leveraged the targeting ability of RGD peptide and the cell penetrating ability of Angiopep-2 peptide to deliver ADSC-EVs precisely to the impaired brain parenchyma. We found that dual-modified EVs (RA-EVs) significantly enhanced the transcellular permeability across BBB in vitro, and not only targeted ischemic blood vessels but also achieved rapid accumulation in the ischemic lesion area after intravenous administration in vivo. RA-EVs further decreased the infarct volume, apoptosis, BBB disruption, and neurobehavioral deficits. RNA sequencing revealed the molecular regulation mechanism after administration. These findings demonstrate that dual-modification optimizes brain parenchymal targeting and highlights the significance of recruitment and penetration as a previously unidentified strategy for harnessing EVs for therapeutic delivery in ischemic stroke.

01 Jan 2024·Cancer treatment reviews

Pharmacotherapy for leptomeningeal disease in breast cancer

Review

Author: Bartsch, Rupert ; Le Rhun, Emilie ; Müller, Volkmar ; Jerzak, Katarzyna J ; Larrouquere, Louis

Clinical data supporting the best therapeutic approach in leptomeningeal disease (LMD; also known as leptomeningeal metastases or leptomeningeal carcinomatosis) are lacking. Despite the development of new agents and increasing incidence of central nervous system metastases, patients with LMD are often excluded from clinical trials in breast cancer, with very few conducted specifically in LMD. Consequently, current evidence may not provide an accurate reflection of real-world clinical practice. This review aims to provide further insight into the treatment strategies for patients with breast cancer and LMD. We explore differences between clinical and real-world studies, considering inclusion criteria, levels of evidence for LMD diagnosis, and time between diagnosis of LMD and LMD-specific treatment initiation. Patient prognosis is poor; median overall survival is limited to several months, with approximately 10% of patients alive at 12 months. Efficacy results have been reported for various systemic and intrathecal agents in LMD to date. Systemic therapies under investigation for LMD in breast cancer include tucatinib, trastuzumab deruxtecan, and paclitaxel trevatide; trastuzumab is the main intrathecal agent currently under investigation. Recent trials investigating systemic or intrathecal therapies are typically small, single-arm studies, and most are restricted to patients with human epidermal growth factor receptor 2-positive breast cancer. Moreover, the variability among inclusion criteria and response assessment tools makes the interpretation of results difficult. Large retrospective cohorts with various inclusion criteria and treatment regimens provide some real-world data. However, there remains an urgent need for randomised clinical trials which include patients with LMD across all breast cancer subtypes.

31 Dec 2023·Aging

Imaging of brain clearance pathways via MRI assessment of the glymphatic system

Article

Author: Zhang, Xiaolei ; Chen, Beibei ; Wu, Renhua ; He, Yi ; Guan, Jitian ; Wang, Xueqing ; Lai, Lingfeng

Glymphatic clearance dysfunction may play an important role in a variety of neurodegenerative diseases and the progression of ageing. However, in vivo imaging of the glymphatic system is challenging. In this study, we describe an MRI method based on chemical exchange saturation transfer (CEST) of the Angiopep-2 probe to visualize the clearance function of the glymphatic system. We injected rats with Angiopep-2 via the tail vein and performed in vivo MRI at 7 T to track differences in Angiopep-2 signal changes; we then applied the same principles in a bilateral deep cervical lymph node ligation rat model and in ageing rats. We demonstrated the feasibility of Angiopep-2 CEST for visualizing the clearance function of the glymphatic system. Finally, a pathological assessment was performed. Within the model group, the deep cervical lymph node ligation group and the ageing group showed higher CEST signal than the control group. We conclude that this new MRI method can visualize clearance in the glymphatic system.

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

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB06171

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Meningeal Carcinomatosis	Phase 3	-	Angiochem, Inc.	01 Dec 2023
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
HER2 Positive Breast Cancer	Phase 3	CN	Hong Kong Sinokang Pharmaceutical Technology Co., Ltd.	24 May 2022
HER2 Positive Breast Cancer	Phase 3	CN	Beijing Shenogen Pharma Group Ltd.	24 May 2022
Brain metastases	Phase 3	CN	Beijing Shenogen Pharma Group Ltd.	24 May 2022
Brain metastases	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	-	Angiochem, Inc.	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01497665 (CTgov)	Phase 2	metastatic non-small cell lung cancer \| Brain metastases	16	GRN1005	wyhhwmrdiw(giepkllshj) = cnfsvcjruq bbzhlrrage (msrsvxbjqr, bfwgrshhkq - idlvifcmmk) View more	-	14 Dec 2015
NCT01480583 (ASCO2015)	Phase 2	Brain metastases	85	ANG1005	yhfqjfstfc(zhjoapdtsw) = rrvxzcknzw npsgyjausv (hylvbooyun ) View more	-	20 May 2015
ASCO2010	Phase 1	Recurrent Malignant Glioma	63	ANG1005	wzpqjoutnd(ntxgquuktn) = myizsyldqr mpzkrhgdeb (hlkaglixul )	Positive	20 May 2010

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

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. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis