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Exelixis’ liver cancer drug cabozantinib meets primary end point in phase 3 trial
By PBR Staff Writer
Exelixis’ liver cancer drug cabozantinib (Cabometyx) has met its primary end point in the global phase 3 Celestial trial.
Contract Research & Services > Clinical Trials > News
Pfizer’s lung cancer drug lorlatinib succeeds in phase 2 trial
Pfizer says that its investigational, next-generation tyrosine kinase inhibitor lorlatinib showed clinically meaningful activity against lung tumors and brain metastases in a phase 2 trial in patients with ALK-positive and ROS1-positive advanced non-small cell lung cancer (NSCLC).
Contract Research & Services > Clinical Trials > News
miRagen Therapeutics reports positive clinical data of MRG-106 in patients with mycosis fungoides form of cutaneous T-cell lymphoma
miRagen Therapeutics has announced new interim results from its ongoing phase 1 clinical trial evaluating the safety, efficacy and pharmacokinetics of MRG-106 in patients with the mycosis fungoides (MF) form of cutaneous T-cell lymphoma (CTCL).
Contract Research & Services > Clinical Trials > News
Human clinical trial commences for first leprosy vaccine candidate
The Infectious Disease Research Institute (IDRI) and American Leprosy Missions have started a Phase 1 clinical trial in humans for leprosy vaccine candidate, the first vaccine developed specifically for leprosy.
Contract Research & Services > Clinical Trials > News
Ardelyx's phase 3 study of Tenapanor for IBS-C meets primary endpoint
Ardelyx has released positive results from its second Phase 3 study of tenapanor, dubbed T3MPO-2, for irritable bowel syndrome with constipation (IBS-C).
Contract Research & Services > Clinical Trials > News
Shield Therapeutics enrolls patients for phase 3 study of IDA drug Feraccru
Shield Therapeutics has completed enrollment of the Phase 3 AEGIS-CKD clinical trial of its European-marketed product, Feraccru.
Contract Research & Services > Clinical Trials > News
NanOlogy begins NanoPac’s phase 2 study to treat ovarian cancer
By PBR Staff Writer
NanOlogy has commenced the Phase 2 clinical study of intraperitoneally (IP) administered NanoPac (nanoparticle paclitaxel) to treat ovarian cancer.
Contract Research & Services > Clinical Trials > News
Bayer, Janssen halt phase III ESUS study of anticoagulant medicine Xarelto
By PBR Staff Writer
Bayer, along with its development partner Janssen Research & Development, has halted the phase III Navigate ESUS study of rivaroxaban (Xarelto), as it demonstrated comparable efficacy between treatment arms.
Contract Research & Services > Clinical Trials > News
Anthem, HealthCore, Boehringer initiate pragmatic clinical trial to study people living with COPD in real-world setting
The first patients have now enrolled in AIRWISE, the world’s largest ever pragmatic clinical trial in chronic obstructive pulmonary disease (COPD) to study how commonly prescribed medicines may reduce the occurrence of exacerbations of COPD.
Contract Research & Services > Clinical Trials > News
Zika vaccine found safe, promising in first human trial
By PBR Staff Writer
A DNA-based Zika vaccine, dubbed GLS-5700, developed by a consortium led by Inovio Pharmaceuticals and GeneOne Life Science succeeded in a phase 1 clinical trial by producing anti-Zika response in humans.
Contract Research & Services > Clinical Trials > News
Motif Bio’s iclaprim meets primary endpoint in second phase 3 ABSSI trial
By PBR Staff Writer
UK-based Motif Bio reported that its skin disorder drug iclaprim has succeeded in a second phase 3 trial in patients with acute bacterial skin and skin structure infections (ABSSSI).
Contract Research & Services > Clinical Trials > News
10,000 to be tested in world’s first trial for universal flu vaccine
By PBR Staff Writer
NHS patients are taking part in a world-first trial for a universal flu vaccine supported by the National Institute for Health Research (NIHR) and delivered by the University of Oxford in Berkshire and Oxfordshire.
Contract Research & Services > Clinical Trials > News
Ablynx’s blood disease drug caplacizumab passes phase 3 aTTP trial
By PBR Staff Writer
Ablynx's blood disease drug caplacizumab succeeded in a phase 3 trial in patients with acquired thrombotic thrombocytopenic purpura (aTTP), a rare autoimmune blood clotting disorder.
Contract Research & Services > Clinical Trials > News
Zynerba cannabis-derived gel for Fragile X syndrome succeeds in phase 2 trial
By PBR Staff Writer
Zynerba Pharmaceuticals reported that its cannabis-derived gel to treat Fragile X syndrome (FXS) dubbed as ZYN002 has yielded positive results in a phase 2 trial.
Contract Research & Services > Clinical Trials > News

PBR Supplier Recommendations

CTL Laboratories - Contract Immune Monitoring and Research
Cellular Technology Limited (CTL), headquartered in Shaker Heights, OH, is a privately held biotechnology company that built its reputation as the global leader in the ELISPOT field over the past two decades by establishing the ELISPOT instrumentation and scientific principles that have helped to define the parameters of ELISPOT research for monitoring of Cell-Mediated Immunity.... Contract Research & Services > Clinical Trials > Suppliers
CRFweb... from Clindox, Suppliers of Clinical Trial Software
CRFweb is the groundbreaking eCRF application brought to you by Clindox. It sets new standards in web-based, clinical trial software. The combination of a comprehensive feature set, incredibly quick set-up time, simplicity of use and flexible pricing means no trial is too large or too small to be practical. The whole process is genuinely DIY, allowing trial managers to really take control of their trial. ... Contract Research & Services > Clinical Trials > Suppliers
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PBR White Paper Recommendations

Cellular Technology Limited: A multicolor Natural Killer cell-mediated cytotoxicity detection By CTL Laboratories
A multicolor Natural Killer cell-mediated cytotoxicity detection using fluorescence and direct cell imaging.... Contract Research & Services > Clinical Trials > White Papers User vs. Software-Dependent Variability of ELISPOT Counts Obtained from ten Different Laboratories By CTL Laboratories
In ELISPOT assays, cytokine spots produced by antigen-specific T cells show a broad spectrum of sizes and densities over variable background. Therefore, even experienced investigators are likely to come up with different spot counts when subjectively judging the minimal spot size/density to be counted and the maximal spot size for the cut off between singlecell-derived spots vs. those created by cell clusters. This study aims to find out whether statistics-based automated gating can harmonize spot counts obtained in different laboratories.... Contract Research & Services > Clinical Trials > White Papers ELISPOT Assays Provide Reproducible Results Among Different Laboratories for T-cell Immune Monitoring - Even in Hands of ELISPOT's Inexperienced Investigators By CTL Laboratories
Measurements of antibodies in bodily fluids (e.g., by ELISA) have provided robust and reproducible results for decades and such assays have been validated for monitoring of B-cell immunity. In contrast, measuring T-cell immunity has proven to be a challenge due to the need to test live cells in functional assays ex vivo. Several previous efforts looking into the reproducibility of ex vivo T-cell assays between different laboratories, or even within the same laboratory, have provided rather discouraging results.... Contract Research & Services > Clinical Trials > White Papers How Frequently are Predicted Peptides Actually Recognised by CD8 Cells? By CTL Laboratories
Detection of antigen-specific CD8 cells relies on the use of peptides that can bind to HLA-Class I molecules. There is extensive knowledge on individual HLA-alleles’ peptide binding requirements and for many antigens immunogenic peptides have been defined. The 32 individual peptides that comprise the CEF peptide pool represent such well-defined peptide determinants for Cytomegalo, Epstein Barr, and Flu virus. We tested 42 healthy human donors on the accuracy of these peptide predictions.... Contract Research & Services > Clinical Trials > White Papers Four-Colour B Cell ELISPOT Assay for Simultaneous Detection of all Four Human IgG Subclasses By CTL Laboratories
ELISPOT assays are a key research tool for enumerating antigen-specific B cells.... Contract Research & Services > Clinical Trials > White Papers See more
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