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https://www.readbyqxmd.com/read/27876365/midyear-commentary-on-trends-in-drug-delivery-and-clinical-translational-medicine-growth-in-biosimilar-complex-injectable-drug-formulation-products-within-evolving-collaborative-regulatory-interagency-fda-ftc-and-doj-practices-and-enforcement
#1
Rodney J Y Ho
Before the 2009 Biologics Price Competition and Innovation Act that enabled the U.S. Federal Drug Administration (FDA) to create the 351(k) Biologic License Application-an abbreviated biosimilar approval process, FDA approved follow-on biomolecule products such as beta-interferon, glucagon, hyaluronidase, and somatropin (human growth hormone) under varying and evolving rules. With the 351(k) Biologic License Application biosimilar approval process in place, currently, there are 4 (licensed in 2015-2016) biosimilars available, namely Neupogen (filgrastim; $1 B/y), Humira (adalumumab; $14...
November 19, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27858859/risk-factors-of-trastuzumab-induced-cardiotoxicity-in-breast-cancer-a-meta-analysis
#2
Zeeshan Jawa, Ruth M Perez, Lydia Garlie, Maharaj Singh, Rubina Qamar, Bijoy K Khandheria, Arshad Jahangir, Yang Shi
BACKGROUND: Trastuzumab targets the human epidermal growth factor receptor 2 oncogene and in combination with first-line therapy results in significantly improved survival outcomes and has thus become standard of care in both adjuvant and metastatic settings. While it is estimated that 1% to 4% of patients treated with trastuzumab will develop heart failure and ∼10% will experience a reduction in left ventricular ejection fraction (LVEF), the patient risk factors associated with trastuzumab-induced cardiotoxicity (TIC) are unclear...
November 2016: Medicine (Baltimore)
https://www.readbyqxmd.com/read/27815036/crispr-mediated-targeting-of-her2-inhibits-cell-proliferation-through-a-dominant-negative-mutation
#3
Huajing Wang, William Sun
With the discovery of the CRISPR/Cas9 technology, genome editing could be performed in a rapid, precise and effective manner. Its potential applications in functional interrogation of cancer-causing genes and cancer therapy have been extensively explored. In this study, we demonstrated the use of the CRISPR/Cas9 system to directly target the oncogene HER2. Directing Cas9 to exons of the HER2 gene inhibited cell growth in breast cancer cell lines that harbor amplification of the HER2 locus. The inhibitory effect was potentiated with the addition of PARP inhibitors...
November 1, 2016: Cancer Letters
https://www.readbyqxmd.com/read/27813707/development-and-preclinical-studies-of-64-cu-nota-pertuzumab-f-ab-2-for-imaging-changes-in-tumor-her2-expression-associated-with-response-to-trastuzumab-by-pet-ct
#4
Karen Lam, Conrad Chan, Raymond M Reilly
We previously reported that microSPECT/CT imaging with (111)In-labeled pertuzumab detected decreased HER2 expression in human breast cancer (BC) xenografts in athymic mice associated with response to treatment with trastuzumab (Herceptin). Our aim was to extend these results to PET/CT by constructing F(ab')2 of pertuzumab modified with NOTA chelators for complexing (64)Cu. The effect of the administered mass (5-200 µg) of (64)Cu-NOTA-pertuzumab F(ab')2 was studied in NOD/SCID mice engrafted with HER2-positive SK-OV-3 human ovarian cancer xenografts...
November 4, 2016: MAbs
https://www.readbyqxmd.com/read/27789023/the-evolution-of-oncology-companion-diagnostics-from-signal-transduction-to-immuno-oncology
#5
REVIEW
Nicholas C Dracopoli, Mark S Boguski
Sixteen oncology drugs have been approved with a companion diagnostic (CDx) test by the FDA. These represent only 9.6% of the 167 oncology drug approvals since 1998, the year the first CDx test for Herceptin was approved. The great majority of CDx tests are for drugs that inhibit signal transduction pathways by either inhibiting the intracellular kinase activity with a small molecule or preventing ligand-induced receptor activation with a monoclonal antibody. In most of these cases, prospective patient selection for the biomarker-positive subpopulation was initiated in or before Phase II...
October 24, 2016: Trends in Pharmacological Sciences
https://www.readbyqxmd.com/read/27770268/sensitizing-effect-of-juglone-is-mediated-by-down-regulation-of-notch1-signaling-pathway-in-trastuzumab-resistant-skbr3-cells
#6
Soraya Sajadimajd, Razieh Yazdanparast
Trastuzumab (Herceptin) monoclonal antibody directed against HER2 receptor has been administered as a treatment for metastatic HER2 positive breast cancer. The problematic issue in treatment of HER2 positive breast cancer cells is commonly the induction of resistance to trastuzumab which might be due to modulation of some vital signaling elements such as Notch1 and Pin1. In this study, we were aimed to investigate whether the cross talk between pin1 and Notch1 has a role in this event. Our results indicated that the expression level of Pin1 in resistant SKBR3 cells increased by about twofold relative to sensitive SKBR3 cells...
October 21, 2016: Apoptosis: An International Journal on Programmed Cell Death
https://www.readbyqxmd.com/read/27749791/possible-efficacy-of-topical-dorzolamide-in-the-treatment-of-paclitaxel-related-cystoid-macular-edema
#7
Rahul Dwivedi, Sambath Tiroumal
PURPOSE: Paclitaxel (Taxol) is a microtubule-stabilizing agent and belongs to the taxane group of chemotherapeutic drugs. It is used to treat numerous malignancies, such as breast and lung cancers. A rare side effect of this drug includes cystoid macular edema (CME), which is presumed to resolve after cessation of Paclitaxel. We present a case of topical Dorzolamide 2% (Trusopt) having a possible successful effect in the treatment of Paclitaxel-related nonresolving CME. By highlighting this rare ocular side effect of a common chemotherapeutic agent, which fails to resolve upon cessation of the drug alone, we suggest a possible treatment that may help other ophthalmologists in their management of similar cases...
October 4, 2016: Retinal Cases & Brief Reports
https://www.readbyqxmd.com/read/27730538/budget-impact-analysis-of-biosimilar-trastuzumab-for-the-treatment-of-breast-cancer-in-croatia
#8
August Cesarec, Robert Likić
BACKGROUND AND OBJECTIVE: Breast cancer is the most common cancer in women and has considerable impact on healthcare budgets and patients' quality of life. Trastuzumab (Herceptin(®)) is a monoclonal antibody directed against the human epidermal growth factor receptor (HER2) for the treatment of breast cancer. Several trastuzumab biosimilars are currently in development. In 2015, trastuzumab was the drug with the highest financial consumption among all drugs in Croatia. This model estimates the 1-year budget impact of the introduction of biosimilar trastuzumab in Croatia...
October 11, 2016: Applied Health Economics and Health Policy
https://www.readbyqxmd.com/read/27726101/lapatinib-resistance-in-her2-cancers-latest-findings-and-new-concepts-on-molecular-mechanisms
#9
Huiping Shi, Weili Zhang, Qiaoming Zhi, Min Jiang
In the era of new and mostly effective molecular targeted therapies, human epidermal growth factor receptor 2 positive (HER2+) cancers are still intractable diseases. Lapatinib, a dual epidermal growth factor receptor (EGFR) and HER2 tyrosine kinase inhibitor, has greatly improved breast cancer prognosis in recent years after the initial introduction of trastuzumab (Herceptin). However, clinical evidence indicates the existence of both primary unresponsiveness and secondary lapatinib resistance, which leads to the failure of this agent in HER2+ cancer patients...
October 10, 2016: Tumour Biology: the Journal of the International Society for Oncodevelopmental Biology and Medicine
https://www.readbyqxmd.com/read/27721408/cytoplasmic-gper-translocation-in-cancer-associated-fibroblasts-mediates-camp-pka-creb-glycolytic-axis-to-confer-tumor-cells-with-multidrug-resistance
#10
T Yu, G Yang, Y Hou, X Tang, C Wu, X-A Wu, L Guo, Q Zhu, H Luo, Y-E Du, S Wen, L Xu, J Yin, G Tu, M Liu
Multiple drug resistance is a challenging issue in the clinic. There is growing evidence that the G-protein-coupled estrogen receptor (GPER) is a novel mediator in the development of multidrug resistance in both estrogen receptor (ER)-positive and -negative breast cancers, and that cancer-associated fibroblasts (CAFs) in the tumor microenvironment may be a new agent that promotes drug resistance in tumor cells. However, the role of cytoplasmic GPER of CAFs on tumor therapy remains unclear. Here we first show that the breast tumor cell-activated PI3K/AKT (phosphoinositide 3-kinase/AKT) signaling pathway induces the cytoplasmic GPER translocation of CAFs in a CRM1-dependent pattern, and leads to the activation of a novel estrogen/GPER/cAMP/PKA/CREB signaling axis that triggers the aerobic glycolysis switch in CAFs...
October 10, 2016: Oncogene
https://www.readbyqxmd.com/read/27714776/trastuzumab-cardiotoxicity-from-clinical-trials-to-experimental-studies
#11
REVIEW
Balazs T Nemeth, Zoltan V Varga, Wen Jin Wu, Pal Pacher
Epidermal growth factor receptor-2 (HER-2) is overexpressed in 20 to 25% of human breast cancers, which is associated with aggressive tumour growth and poor prognosis. Trastuzumab (Herceptin®) is a humanized monoclonal antibody directed against HER-2, the first highly selective form of therapy targeting HER-2 overexpressing tumours. Although initial trials indicated high efficacy and a favourable safety profile of the drug, the first large, randomized trial prompted a retrospective analysis of cardiac dysfunction in earlier trials utilizing trastuzumab...
October 7, 2016: British Journal of Pharmacology
https://www.readbyqxmd.com/read/27714198/one-pot-n-glycosylation-remodeling-of-igg-with-non-natural-sialylglycopeptides-enables-glycosite-specific-and-dual-payload-antibody-drug-conjugates
#12
Feng Tang, Yang Yang, Yubo Tang, Shuai Tang, Liyun Yang, Bingyang Sun, Bofeng Jiang, Jinhua Dong, Hong Liu, Min Huang, Mei-Yu Geng, Wei Huang
Chemoenzymatic transglycosylation catalyzed by endo-S mutants is a powerful tool for in vitro glycoengineering of therapeutic antibodies. In this paper, we report a one-pot chemoenzymatic synthesis of glycoengineered Herceptin using an egg-yolk sialylglycopeptide (SGP) substrate. Combining this one-pot strategy with novel non-natural SGP derivatives carrying azido or alkyne tags, glycosite-specific conjugation was enabled for the development of new antibody-drug conjugates (ADCs). The site-specific ADCs and semi-site-specific dual-drug ADCs were successfully achieved and characterized with SDS-PAGE, intact antibody or ADC mass spectrometry analysis, and PNGase-F digestion analysis...
October 12, 2016: Organic & Biomolecular Chemistry
https://www.readbyqxmd.com/read/27704775/rational-design-of-dual-agonist-antibody-fusions-as-long-acting-therapeutic-hormones
#13
Yan Liu, Ying Wang, Yong Zhang, Tao Liu, Haiqun Jia, Huafei Zou, Qiangwei Fu, Yuhan Zhang, Lucy Lu, Elizabeth Chao, Holly Parker, Van Nguyen-Tran, Weijun Shen, Danling Wang, Peter G Schultz, Feng Wang
Recent studies have suggested that modulation of two or more signaling pathways can achieve substantial weight loss and glycemic stability. We have developed an approach to the generation of bifunctional antibody agonists that activate leptin receptor and GLP-1 receptor. Leptin was fused into the complementarity determining region 3 loop of the light chain alone, or in combination with exendin-4 (EX4) fused at the N-terminus of the heavy chain of Herceptin. The antibody fusions exhibit similar or increased in vitro activities on their cognate receptors, but 50-100-fold longer circulating half-lives in rodents compared to the corresponding native peptides/proteins...
October 5, 2016: ACS Chemical Biology
https://www.readbyqxmd.com/read/27686050/herceptin-functionalized-pure-paclitaxel-nanocrystals-for-enhanced-delivery-to-her2-postive-breast-cancer-cells
#14
Jin-Ki Noh, Muhammad Naeem, Jiafu Cao, Eun Hee Lee, Min-Soo Kim, Yunjin Jung, Jin-Wook Yoo
The objective of this study was to prepare Herceptin (HCT)-functionalized paclitaxel nanocrystals and evaluated their cell-specific interactions, cellular accumulation, and growth inhibition in HER2-positve breast cancer cells as a tumor-targeted delivery module. Paclitaxel (PTX) was fabricated in the form of nanocrystals (PNCs) by a sono-precipitation method, and HCT were coated using a facile non-covalent method (PNCs-HCT). Our results showed that the PNCs-HCT were stable for at least 1month at 4°C with no noticeable desorption of HCT...
September 26, 2016: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/27669438/cxcr4-inhibitors-could-benefit-to-her2-but-not-to-triple-negative-breast-cancer-patients
#15
S Lefort, A Thuleau, Y Kieffer, P Sirven, I Bieche, E Marangoni, A Vincent-Salomon, F Mechta-Grigoriou
The CXCR4 receptor and its ligand CXCL12 (also named stromal cell-derived factor 1, SDF1) have a critical role in chemotaxis and homing, key steps in cancer metastasis. Although myofibroblasts expressing CXCL12 are associated with the presence of axillary metastases in HER2 breast cancers (BC), the therapeutic interest of targeting CXCR4/CXCL12 axis in the different BC subtypes remains unclear. Here, we investigate this question by testing antitumor activity of CXCR4 inhibitors in patient-derived xenografts (PDX), which faithfully reproduce human tumor properties...
September 26, 2016: Oncogene
https://www.readbyqxmd.com/read/27635041/commentary-on-recombinant-humanized-anti-her2-antibody-herceptin-enhances-the-antitumor-activity-of-paclitaxel-and-doxorubicin-against-her2-neu-overexpressing-human-breast-cancer-xenografts-a-follow-up
#16
https://www.readbyqxmd.com/read/27632934/gene-therapy-using-plasmid-dna-encoded-anti-her2-antibody-for-cancers-that-overexpress-her2
#17
H Kim, S N Danishmalik, H Hwang, J-I Sin, J Oh, Y Cho, H Lee, M Jeong, S-H Kim, H J Hong
Plasmid DNA-encoded antibodies, or DNA-based monoclonal antibodies (dMAbs), are delivered by intramuscular injection and in vivo electroporation (EP) and are effective in virus neutralization, although they have not been evaluated for tumor gene therapy. Here we investigated whether a dMAb was appropriate for tumor gene therapy. We constructed the expression plasmids coding for the heavy or light chain of a parental murine antibody of Herceptin with the antibody genes codon- and RNA-optimized and fused to the Kozak-IgE leader sequence in pVax1...
October 2016: Cancer Gene Therapy
https://www.readbyqxmd.com/read/27628098/global-longitudinal-strain-a-useful-everyday-measurement
#18
A King, J Thambyrajah, E Leng, M J Stewart
Herceptin (Trastuzumab) is a widely used and effective drug for the treatment of Her2+ breast cancer but its cardiotoxic side effects require regular monitoring by echocardiography. A 10% reduction in left ventricular ejection fraction can lead to suspension of treatment and therefore has significant implications for patient prognosis in terms of cardiac and cancer outcomes. Assessment of LV function by conventional 2D biplane method of discs (2DEF) has limitations in accuracy and reproducibility. Global longitudinal strain (GLS) is becoming more widely available and user friendly...
September 2016: Echo Research and Practice
https://www.readbyqxmd.com/read/27620140/orthogonal-assessment-of-biotherapeutic-glycosylation-a-case-study-correlating-n-glycan-core-afucosylation-of-herceptin-with-mechanism-of-action
#19
Rosie Upton, Leonard Bell, Colin Guy, Paul Caldwell, Sian Estdale, Perdita E Barran, David Firth
In the development of therapeutic antibodies and biosimilars, an appropriate biopharmaceutical CMC control strategy that connects critical quality attributes with mechanism of action should enable product assessment at an early stage of development in order to mitigate risk. Here we demonstrate a new analytical workflow using trastuzumab which comprises "middle-up" analysis using a combination of IdeS and the endoglycosidases EndoS and EndoS2 to comprehensively map the glycan content. Enzymatic cleavage between the two N-acetyl glucosamine residues of the chitobiose core of N-glycans significantly simplifies the oligosaccharide component enabling facile distinction of GlcNAc from GlcNAc with core fucose...
October 18, 2016: Analytical Chemistry
https://www.readbyqxmd.com/read/27617041/subgroup-based-adaptive-suba-designs-for-multi-arm-biomarker-trials
#20
Yanxun Xu, Lorenzo Trippa, Peter Müller, Yuan Ji
Targeted therapies based on biomarker profiling are becoming a mainstream direction of cancer research and treatment. Depending on the expression of specific prognostic biomarkers, targeted therapies assign different cancer drugs to subgroups of patients even if they are diagnosed with the same type of cancer by traditional means, such as tumor location. For example, Herceptin is only indicated for the subgroup of patients with HER2+ breast cancer, but not other types of breast cancer. However, subgroups like HER2+ breast cancer with effective targeted therapies are rare and most cancer drugs are still being applied to large patient populations that include many patients who might not respond or benefit...
June 2016: Statistics in Biosciences
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