199,565 results match your criteria safety efficacy


Prophylactic Central Neck Dissection in Papillary Thyroid Carcinoma: All Risks, No Reward.

J Surg Res 2021 Apr 7;264:230-235. Epub 2021 Apr 7.

Department of Surgery, The University of Alabama at Birmingham, Birmingham, Alabama. Electronic address:

Background: Central neck dissection (CND) remains a controversial intervention for papillary thyroid carcinoma (PTC) patients with clinically negative nodes (cN0) in the central compartment. Proponents state that CND in cN0 patients prevents locoregional recurrence, while opponents deem that the risks of complications outweigh any potential benefit. Thus, there remains conflicting results amongst studies assessing oncologic and surgical outcomes in cN0 PTC patients who undergo CND. Read More

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Onlay Poly-4-Hydroxybutyrate (P4HB) Mesh for Complex Hernia: Early Clinical and Patient Reported Outcomes.

J Surg Res 2021 Apr 7;264:199-207. Epub 2021 Apr 7.

Division of Plastic Surgery, Department of Surgery, University of Pennsylvania, Philadelphia, PA. Electronic address:

Background: While mesh re-enforcement and advanced surgical techniques are cornerstones of complex ventral hernia repair (CVHR), the risk of complications and recurrence is common. We aim to evaluate the efficacy, safety, and patient reported outcomes (PROs) of patients undergoing CVHR with onlay Poly-4-hydroxybutyrate (P4HB).

Methods: Adult (>18 y old) patients undergoing VHR with P4HB (Phasix) in the onlay plane by a single surgeon from 01/2015 to 05/2020 were reviewed. Read More

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Lubiprostone for Pediatric Functional Constipation: Randomized, Controlled, Double-blind Study With Long-term Extension.

Clin Gastroenterol Hepatol 2021 Apr 7. Epub 2021 Apr 7.

Pediatric Gastroenterologist, Division of Pediatric Gastroenterology, Nationwide Children's Hospital, Columbus, OH, USA. Electronic address:

Background & Aims: Pediatric functional constipation (PFC) is a common problem in children that causes distress and presents treatment challenges to healthcare professionals. We conducted a randomized, placebo-controlled trial (Study 1) in patients with PFC (aged 6-17 years) to evaluate the efficacy and safety of lubiprostone, followed by an open-label extension for those who completed the placebo-controlled phase (Study 2).

Methods: Study 1 (NCT02042183) was a phase 3, multicenter, randomized, double-blind, placebo-controlled, 12-week study evaluating the efficacy and safety of lubiprostone 12 mcg twice-daily (BID) and 24 mcg BID. Read More

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Therapeutic plasma exchange in patients with life-threatening COVID-19: a randomized control clinical trial.

Int J Antimicrob Agents 2021 Apr 7:106334. Epub 2021 Apr 7.

Research & Innovation Centre, King Saud Medical City, Riyadh, Saudi Arabia; Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA. Electronic address:

Objective: To assess the efficacy of therapeutic plasma exchange (TPE) following life-threatening COVID-19.

Design, Setting, And Participants: Open-label, randomized clinical trial of intensive care unit (ICU) patients with life-threatening COVID-19 [positive real-time-polymerase-chain-reaction test, plus acute respiratory distress syndrome (ARDS), sepsis, organ failure, hyperinflammation]. The study was terminated after 87/120 patients were enrolled. Read More

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Voxelotor in adolescents and adults with sickle cell disease (HOPE): long-term follow-up results of an international, randomised, double-blind, placebo-controlled, phase 3 trial.

Lancet Haematol 2021 Apr 7. Epub 2021 Apr 7.

UCSF Benioff Children's Hospital Oakland, Oakland, CA, USA.

Background: For decades, patients with sickle cell disease have had only a limited number of therapies available. In 2019, voxelotor (1500 mg), an oral once-daily sickle haemoglobin polymerisation inhibitor, was approved in the USA for the treatment of sickle cell disease in patients aged 12 years and older on the basis of HOPE trial data. To further describe the applicability of voxelotor as a treatment for this chronic illness, we report the long-term efficacy and safety of this drug at 72 weeks of treatment; the conclusion of the placebo-controlled HOPE trial. Read More

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Does Inhaled Methoxyflurane Implement Fast and Efficient Pain Management in Trauma Patients? A Systematic Review and Meta-Analysis.

Pain Ther 2021 Apr 10. Epub 2021 Apr 10.

Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, China.

Introduction: Evidence on the use of inhaled methoxyflurane in the management of trauma pain is conflicting and obfuscated. This study aimed to determine the efficacy and safety of inhaled methoxyflurane for trauma pain on the basis of published randomized controlled trials (RCTs).

Methods: RCTs assessing the efficacy of methoxyflurane in adults or adolescents with acute trauma pain published in PubMed, Web of Science, Embase, Cochrane Library, and Google Scholar were searched. Read More

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Semaglutide Once-Weekly Persistence and Adherence Versus Other GLP-1 RAs in Patients with Type 2 Diabetes in a US Real-World Setting.

Diabetes Ther 2021 Apr 10. Epub 2021 Apr 10.

Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ, 08536, US.

Introduction: The superior efficacy and safety of semaglutide once-weekly (QW), compared with dulaglutide, liraglutide, or exenatide QW, have been demonstrated in the SUSTAIN trials. This study assessed treatment persistence and adherence to semaglutide QW versus dulaglutide, liraglutide, or exenatide QW in a real-world setting.

Methods: This retrospective, database study used Optum's de-identified Clinformatics® Data Mart Database to identify glucagon-like peptide 1 receptor agonist (GLP-1 RA) treatment-naïve adult patients with type 2 diabetes (T2D) initiating semaglutide QW, dulaglutide, liraglutide, or exenatide QW between January 1, 2018 and April 30, 2019. Read More

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Global Greenlight Group: largest international Greenlight experience for benign prostatic hyperplasia to assess efficacy and safety.

World J Urol 2021 Apr 10. Epub 2021 Apr 10.

Department of Urology, University of Montreal Hospital Center CHUM, Montreal, QC, Canada.

Introduction: Greenlight photo-selective vaporization of the prostate (GL-PVP) has gained international acceptance as a safe and effective alternative procedure for the treatment of benign prostatic hyperplasia (BPH), especially in anticoagulated men. This descriptive analysis aims to characterize the current state of GL-PVP, pooling data from international centers.

Methods: Data from 3627 patients who underwent GL-PVP with the XPS-180 W system in seven international centers performed by eight expert surgeons between 2011 and 2019 were retrospectively analyzed. Read More

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Multisystem Spinal Cord Stimulation Trialing: A Single Center, Retrospective, Observational Study.

Pain Pract 2021 Apr 10. Epub 2021 Apr 10.

Evolve Restorative Center, Santa Rosa, CA, USA.

Background: Spinal cord stimulation is a well established modality for the treatment of chronic intractable pain. The safety and efficacy of various stimulation therapy designs have been demonstrated in multiple randomized controlled studies, oftentimes comparing an investigational device to an existing commercial therapy. In the real-world setting, data is lacking regarding selection of SCS therapy, as waveform, pulse trains, and programming are not interchangeable amongst the devices. Read More

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Cost Effectiveness of Ceftolozane/Tazobactam Compared with Meropenem for the Treatment of Patients with Ventilated Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia.

Infect Dis Ther 2021 Apr 9. Epub 2021 Apr 9.

Merck & Co., Inc., Kenilworth, NJ, USA.

Introduction: The clinical efficacy and safety of ceftolozane/tazobactam for the treatment of ventilated hospital-acquired bacterial pneumonia (vHABP) and ventilator-associated bacterial pneumonia (VABP) has been demonstrated in the phase III randomised controlled trial ASPECT-NP. However, there are no published data on the cost-effectiveness of ceftolozane/tazobactam for vHABP/VABP. These nosocomial infections are associated with high rates of morbidity and mortality, and are increasingly complicated by growing rates of resistance and the inappropriate use of antimicrobials. Read More

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Treatment of Chronic Aplastic Anemia with Chinese Patent Medicine Pai-Neng-Da Capsule () for Replacing Androgen Partially: A Clinical Multi-Center Study.

Chin J Integr Med 2021 Apr 10. Epub 2021 Apr 10.

Institute of Hematology Research, the First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, 310006, China.

Objective: To evaluate the efficacy and safety of Pai-Neng-Da Capsule (, panaxadiol saponins component, PNDC) in combination with the cyclosporine and androgen for patients with chronic aplastic anemia (CAA).

Methods: A total of 79 CAA patients was randomly divided into 2 groups by a random number table, including PCA group [43 cases, orally PNDC 320 mg/d plus cyclosporine 5 mg/(kg·d) plus andriol 80 mg/d] and CA group [36 cases, orally cyclosporine 5 mg/(kg·d) plus andriol 160 mg/d]. All patients were treated and followed-up for 6 treatment courses over 24 weeks. Read More

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PASCAL mitral valve repair system versus MitraClip: comparison of transcatheter edge-to-edge strategies in complex primary mitral regurgitation.

Clin Res Cardiol 2021 Apr 10. Epub 2021 Apr 10.

Clinic for General and Interventional Cardiology/Angiology, Herz- Und Diabeteszentrum NRW, Ruhr-Universität Bochum, Georgstraße 11, 32545, Bad Oeynhausen, Germany.

Background: The PASCAL system is a novel device for edge-to-edge treatment of mitral regurgitation (MR). The aim of this study was to compare the safety and efficacy of the PASCAL to the MitraClip system in a highly selected group of patients with complex primary mitral regurgitation (PMR) defined as effective regurgitant orifice area (MR-EROA) ≥ 0.40 cm, large flail gap (≥ 5 mm) or width (≥ 7 mm) or Barlow's disease. Read More

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The berry health tool chest - an evidence map and interactive resource.

Nutr Rev 2021 Apr 9. Epub 2021 Apr 9.

K.L. Kay, R.C. Strauch, C.D. Granillo, M.W Bame, J. Xiong, A.C. Mast, C.D. Kay, and M.A. Lila are with the Food Bioprocessing and Nutrition Sciences Department, Plants for Human Health Institute, North Carolina State University, North Carolina Research Campus, Kannapolis, North Carolina, USA. B. Burton-Freeman is with the Department of Food Science and Nutrition, Center for Nutrition Research, Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, Ilinois, USA.

Berry consumption is linked to diverse health benefits, but numerous questions remain regarding mechanism of action, dose efficacy, and optimal duration and frequency of intake. Addressing these outstanding questions requires an organized assessment of current research, to inform future study designs and fill critical knowledge gaps. Tools that organize such information will also facilitate consumer messaging, targeted nutritional health initiatives, and dietary intake guidelines. Read More

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Social trauma as a contributory factor in Filipino's vaccine hesitancy.

J Public Health (Oxf) 2021 Apr 9. Epub 2021 Apr 9.

Institute of Arts, Sciences, and Teacher Education, Mabalacat City College, Mabalacat City 2010, Philippines.

Despite of the Government's effort to persuade the public to participate in its vaccination program against COVID-19, vaccine hesitancy remains to be a big challenge in the Philippines. While various efforts were undertaken to promote the safety and efficacy of vaccines against COVID-19, it is imperative that the Philippine government considers social traumas as a factor in vaccine hesitancy. This study proposes Judith Herman's stages of trauma recovery as a possible framework that could be utilize by the government in its drive to increase public trust. Read More

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Second-generation laser balloon ablation for the treatment of atrial fibrillation assessed by continuous rhythm monitoring: the LIGHT-AF study.

Europace 2021 Apr 9. Epub 2021 Apr 9.

Arrhythmology Department, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.

Aims: Balloon-based technologies have been developed to simplify catheter ablation of atrial fibrillation (AF), to improve the clinical outcome of the procedure and to achieve durable pulmonary vein isolation (PVI). The objective of this study is to evaluate the safety and efficacy of second-generation laser balloon (LB2) ablation in the treatment of AF using a continuous cardiac rhythm monitoring strategy. Atrial tachyarrhythmias (ATas) recurrences were assessed with implantable cardiac monitors (ICMs) or devices. Read More

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Serotherapy-Free Regimen Improves Non-Relapse Mortality and Immune Recovery Among the Recipients of αβ TCell-Depleted Haploidentical Grafts: Retrospective Study in Childhood Leukemia.

Transplant Cell Ther 2021 Apr 14;27(4):330.e1-330.e9. Epub 2021 Jan 14.

Department of Hematopoietic Stem Cell Transplantation, Dmitriy Rogachev National Medical Center Of Pediatric Hematology, Oncology And Immunology, Moscow, Russia. Electronic address:

Depletion of αβ T cells from the graft prevents graft-versus-host disease (GVHD) and improves the outcome of hematopoietic stem cell transplantation (HSCT) from haploidentical donors. Delayed recovery of adaptive immunity remains a problem, which can be approached by adoptive T-cell transfer. In a randomized trial, we have assessed the safety and efficacy of low-dose memory (CD45RA-depleted) donor lymphocytes (mDLI) after HSCT with αβ T-cell depletion. Read More

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Randomized clinical trial to compare the efficacy of ivermectin versus placebo to negativize nasopharyngeal PCR in patients with early COVID-19 in Peru (SAINT-Peru): a structured summary of a study protocol for randomized controlled trial.

Trials 2021 Apr 9;22(1):262. Epub 2021 Apr 9.

School of Public Health and Administration, Universidad Peruana Cayetano Heredia, Lima, Peru.

Objectives: The primary objective is to determine the effect of a daily dose of ivermectin administered in three consecutive days to non-severe COVID-19 patients with no more than 96 hours of symptoms, on the detection of SARS-CoV-2 RNA by PCR from nasopharyngeal swabs at day seven post-treatment initiation. The secondary objectives are: 1. To assess the efficacy of ivermectin to reduce the SARS-CoV-2 viral load in the nasopharyngeal swab on days 4, 7, 14 and 21 post-treatment initiation 2. Read More

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Efficacy and safety of sprifermin injection for knee osteoarthritis treatment: a meta-analysis.

Arthritis Res Ther 2021 Apr 9;23(1):107. Epub 2021 Apr 9.

Department of Rehabilitation Medicine, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.

Objective: To perform a meta-analysis comparing the structural progression and clinical symptom outcomes as well as adverse events experienced from intra-articular injections of sprifermin compared to a placebo treatment for patients with knee osteoarthritis (KOA).

Method: We systematically searched the literature for studies that compared long-term outcomes between sprifermin and placebo injections for KOA treatment. Meta-analysis was performed with RevMan5. Read More

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A prospective study investigating the efficacy and toxicity of definitive ChemoRadiation and ImmunOtherapy (CRIO) in locally and/or regionally advanced unresectable cutaneous squamous cell carcinoma.

Radiat Oncol 2021 Apr 9;16(1):69. Epub 2021 Apr 9.

Department of Medical Oncology, Royal Brisbane and Women's Hospital, Butterfield Street, Herston, QLD, Australia.

Background: Patients with unresectable advanced cutaneous squamous cell carcinoma (cSCC) are generally treated with palliative intent. Immune checkpoint blockade has significant activity in the palliative setting in patients with recurrent or metastatic cSCC. This single arm phase 2 prospective study aims to investigate the combination of curative intent chemoradiation and durvalumab (anti-PD-L1 checkpoint inhibitor) for this patient cohort. Read More

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Safety and efficacy of secondary mandibular reconstruction using a free osteo-cutaneous fibula flap after segmental mandibular resection: a retrospective case-control study.

BMC Surg 2021 Apr 9;21(1):189. Epub 2021 Apr 9.

Division of Plastic and Reconstructive Surgery, Faculty of Medicine Shimane University, 89-1 Enya-cho, Izumo, Shimane, 693-8501, Japan.

Background: Free osteocutaneous fibula flap (FFF) is currently considered the best option for segmental mandibular reconstruction; however, there are only a few reports comparing secondary with primary reconstructions using FFF. This study aimed to evaluate the safety and efficacy of secondary mandibular reconstruction using FFF when compared with primary mandibular reconstruction.

Methods: From October 2018 to February 2020, patients who underwent mandibular reconstruction using FFF after segmental mandibulectomy were retrospectively reviewed. Read More

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Propensity-score-matching analysis to compare efficacy and safety between 16-gauge and 18-gauge needle in ultrasound-guided biopsy for peripheral pulmonary lesions.

BMC Cancer 2021 Apr 9;21(1):390. Epub 2021 Apr 9.

Department of Medical Ultrasonics, Nanfang Hospital, Southern Medical University, No. 1838, North Guangzhou Avenue, Guangzhou, 510515, Guangdong, China.

Background: Definitive diagnosis of peripheral pulmonary lesions (PPLs) depends on the histological analysis of the pleural biopsy sample. Ultrasound (US)-guided sampling is now standard practice in the clinical setting. However, determining a suitable needle size and sampling times to improve the efficacy and safety of the biopsy remains challenging. Read More

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Safety considerations for the management of cholestatic itch.

Expert Opin Drug Saf 2021 Apr 9. Epub 2021 Apr 9.

Division of Digestive Health and Liver Disease, University of Miami Miller School of Medicine, Miami, FL.

Introduction: Pruritus is a disabling symptom common to cholestatic liver disorders. Its pathophysiology has not been completely elucidated and although multiple mediators have been identified, only lysophosphatidic acid (LPA) and its synthetizing enzyme autotaxin (ATX) appear to consistently correlate with symptom intensity. This review aims to summarize the most relevant safety and efficacy data regarding both standard and new medications utilized to treat pruritus in cholestatic liver disease. Read More

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Do histone deacytelase inhibitors and azacitidine combination hold potential as an effective treatment for high/very-high risk myelodysplastic syndromes?

Expert Opin Investig Drugs 2021 Apr 9. Epub 2021 Apr 9.

Division of Hematology and Medical Oncology, Department of Medicine, Medical College of Wisconsin, USA.

Introduction: : Myelodysplastic syndrome (MDS) is a clonal hematopoietic stem cell disorder, predominantly seen in elderly patients with variable clinical outcome and high tendency for leukemic transformation. Allogeneic hematopoietic stem cell transplantation (alloHCT) is the only potential curative option but limited to a selected group of patients, for the rest, disease control is the goal and enrollment in clinical trial is always encouraged. Mechanistically, azacitidine (AZA) and histone deacetylase inhibitors (HDACi) is a promising combination for patient with high risk MDS to improve clinical outcome, but the combination has yet to demonstrate its efficacy in randomized clinical trials. Read More

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Venetoclax combinations induce high response rates in newly diagnosed Acute Myeloid Leukemia patients ineligible for intensive chemotherapy in routine practice.

Am J Hematol 2021 Apr 9. Epub 2021 Apr 9.

Department of Hematology, Shamir Medical Center (formerly Assaf Harofe Medical Center), Zerifin, Israel, affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

Combinations of the BCL-2 inhibitor, venetoclax, with either hypomethylating agents (HMA), or low dose cytarabine (LDAC), have shown promising results in clinical trials of AML patients unfit for intensive therapy. We report on the efficacy and safety of AML patients that were treated with venetoclax combinations outside of clinical trials. Data on 133 patients with a mean age of 77 years is included. Read More

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Renal replacement therapy modality in critically ill patients with acute kidney injury - A network meta-analysis of randomized controlled trials.

J Crit Care 2021 Mar 25;64:82-90. Epub 2021 Mar 25.

Department of Intensive Care Medicine, HwaMei Hospital, University of Chinese Academy of Sciences, Ningbo, Zhejiang 315000, China; Ningbo Institute of Life and Health Industry, University of Chinese Academy of Sciences, Ningbo, Zhejiang 315000, China. Electronic address:

Purpose: This network meta-analysis aims to compare the efficacy and safety of various renal replacement therapy (RRT) modalities in critically ill patients with acute kidney injury (AKI).

Materials And Methods: We searched the electronic databases for randomized controlled trials (RCTs) comparing different RRT modalities, including continuous RRT, intermittent RRT, hybrid RRT, and peritoneal dialysis (PD), in critically ill patients with AKI through July 26, 2020. The primary outcomes were renal recovery and short-term mortality. Read More

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New regimens of benznidazole monotherapy and in combination with fosravuconazole for treatment of Chagas disease (BENDITA): a phase 2, double-blind, randomised trial.

Lancet Infect Dis 2021 Apr 6. Epub 2021 Apr 6.

DNDi Latin America, Rio de Janeiro, Brazil; Epidemiology and Public Health Research Centre, CONICET, Buenos Aires, Argentina. Electronic address:

Background: Current treatment for Chagas disease with the only available drugs, benznidazole or nifurtimox, has substantial limitations, including long treatment duration and safety and tolerability concerns. We aimed to evaluate the efficacy and safety of new benznidazole monotherapy regimens and combinations with fosravuconazole, in the treatment of Chagas disease.

Methods: We did a double-blind, double-dummy, phase 2, multicentre, randomised trial in three outpatient units in Bolivia. Read More

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Efficacy and safety of pembrolizumab in patients with advanced mesothelioma in the open-label, single-arm, phase 2 KEYNOTE-158 study.

Lancet Respir Med 2021 Apr 6. Epub 2021 Apr 6.

University of Chicago, Chicago, IL, USA.

Background: Malignant pleural mesothelioma (MPM) has few treatment options. Pembrolizumab showed preliminary clinical benefit in programmed death ligand 1 (PD-L1)-positive MPM. We evaluated the efficacy and safety of pembrolizumab monotherapy in patients with previously treated MPM irrespective of PD-L1 status in the KEYNOTE-158 study. Read More

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Ivosidenib for the treatment of isocitrate dehydrogenase-1 mutant cholangiocarcinoma.

Expert Rev Gastroenterol Hepatol 2021 Apr 9. Epub 2021 Apr 9.

Department of Medical Oncology, St. James's Hospital, Dublin 8, Ireland.

: Cholangiocarcinomas (CCAs) are associated with poor survival outcomes, with limited treatment options in the unresectable or metastatic setting. A precision medicine approach to cancer treatment has revealed new therapeutic options that provide an alternative to traditional chemotherapeutic strategies. Isocitrate dehydrogenase 1 () mutations are identified in approximately 10-15% of CCAs and may be targeted by ivosidenib, an oral selective inhibitor of mutant . Read More

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Robotic-assisted laparoscopic tumor enucleation is a feasible technique for renal hilar tumors: A retrospective study.

J Surg Oncol 2021 Apr 9. Epub 2021 Apr 9.

Department of Urology, Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, China.

BACKGROUND AND OBJECTIVE: This study aimed to evaluate the safety and efficacy of robot-assisted laparoscopic tumor enucleation (RAE) for the treatment of renal hilar tumors and to describe our experience with renorrhaphy-related surgical techniques.

Methods: Retrospective data were collected from 173 consecutive patients who underwent RAE for localized renal tumors (cT1-cT2N0M0) at our hospital between September 2014 and November 2019.

Results: Seventy-five patients had renal hilar tumors and 98 patients had nonhilar tumors. Read More

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Comprehensive mutagenesis identifies the peptide repertoire of a p53 T-cell receptor mimic antibody that displays no toxicity in mice transgenic for human HLA-A*0201.

PLoS One 2021 9;16(4):e0249967. Epub 2021 Apr 9.

Nuffield Division of Clinical Laboratory Science, Radcliffe Department of Medicine, John Radcliffe Hospital, University of Oxford, Oxford, United Kingdom.

T-cell receptor mimic (TCRm) antibodies have expanded the repertoire of antigens targetable by monoclonal antibodies, to include peptides derived from intracellular proteins that are presented by major histocompatibility complex class I (MHC-I) molecules on the cell surface. We have previously used this approach to target p53, which represents a valuable target for cancer immunotherapy because of the high frequency of its deregulation by mutation or other mechanisms. The T1-116C TCRm antibody targets the wild type p5365-73 peptide (RMPEAAPPV) presented by HLA-A*0201 (HLA-A2) and exhibited in vivo efficacy against triple receptor negative breast cancer xenografts. Read More

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