September 2019

Features

Expert Q&A: Site Feasibility Factors

September 30, 2019

Diane Carozza, WCG vice president of clinical strategic services, and Danya Kaye, director of business development for R&D and innovation at Inspire, share their thoughts on a variety of issues related to successful site feasibility practices.

Up and Coming

Up and Coming from Aperio, CASI Pharmaceuticals and Illumina

September 30, 2019

This feature highlights changes in clinical research organizations’ personnel.

AGC Biologics
Naofumi Kagami was named site head and general manager of the Chiba, Japan facility at AGC Biologics. Previously, Kagami was head of bioprocess solution sales with Sartorius Stedim Japan and marketing manager with Roche.

Pipeline

New Pipeline Updates from Neuralstem Inc., Annexon Biosciences and Abiomed

September 30, 2019

Company Drug/Device Medical Condition Status
BioLineRx Ltd. AGI-134 solid tumors Phase 1/2a trial initiated enrolling subjects at 15 sites in the U.S., U.K. and Israel
Neuralstem Inc. NSI-566 chronic ischemic stroke Phase 2 trial initiated enrolling 22 subjects with sustained chronic motor deficits due to an ischemic stroke
Oragenics, Inc. AG013 severe oral mucositis Phase 2 trial initiated enrolling 200 subjects at 59 sites in the U.S. and Europe
ImaginAB, Inc. 89Zr-Df-IAB22M2C cancer Phase 2 trial initiated enrolling subjects with advanced and metastatic cancer at the O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham
Oncopeptides AB melflufen in combination with dexamethasone relapsed/refractory multiple myeloma (RRMM) Phase 2 trial initiated enrolling 150 subjects
Rigel Pharmaceuticals, Inc.
Kissei Pharmaceuticals Co., Ltd.
fostamatinib disodium hexahydrate chronic immune thrombocytopenia (ITP) Phase 3 study initiated enrolling adult subjects with ITP
Protalix BioTherapeutics, Inc.
Chiesi Farmaceutici S.p.A.
PRX 102 (pegunigalsidase alfa) Fabry disease with impaired renal function Phase 3 trial initiated enrolling subjects previously treated with an enzyme replacement therapy: agalsidase alfa or agalsidase beta
Ocular Therapeutix, Inc. DEXTENZA allergic conjunctivitis (AC) Phase 3 trial initiated enrolling 80 subjects
Annexon Biosciences ANX005 Guillain-Barré Syndrome (GBS) Fast Track approval granted by the FDA
Merck & Company PIFELTRO (in combination with other antiretroviral agents) HIV-1 in adult subjects who are virologically suppressed sNDA approval granted by the FDA
Merck & Company DELSTRIGO HIV-1 in adult subjects who are virologically suppressed sNDA approval granted by the FDA
Abiomed Impella 5.5 with SmartAssist minimally invasive forward flow heart pump residual myocardial function PMA approval granted by the FDA
Novo Nordisk Rybelsus (semaglutide) oral tablets type 2 diabetes Approval granted by the FDA
Exact Sciences Corp. Cologuard noninvasive colorectal cancer screening test for subjects ages 45 and older Approval granted by the FDA
Bavarian Nordic A/S Jynneos Smallpox and Monkeypox Vaccine, Live, Non-Replicating smallpox and monkeypox disease in adults 18 years of age and older Approval granted by the FDA

 

Features

Half of EU Cancer Trials Show Bias, Study Says

September 23, 2019

Half of all cancer drugs approved by the European Medicines Agency (EMA) from 2014 to 2016 were the result of trials that exhibited a high risk of bias and even exaggerated treatment effects, a new research study says.

Pipeline

New Pipeline Updates from Immunic, Pulmatrix and Janssen

September 23, 2019

Company Drug/Device Medical Condition Status
Clover Biopharmaceuticals, Inc. SCB-313 peritoneal carcinomatosis Phase 1 trial initiated enrolling subjects in China
Immunic IMU-935 various inflammatory and autoimmune diseases Phase 1 trial initiated
Benitec Biopharma BB-301 Oculopharyngeal Muscular Dystrophy (OPMD) Phase 1 trial initiated
Transgene TG4050 HPV negative, squamous cell carcinoma of the head and neck (SCCHN) Phase 1 trial initiated enrolling subjects that have received an adjuvant (first line) therapy in the UK and France
Transgene TG4050 ovarian cancer Phase 1 trials initiated enrolling subjects after first-line surgery and chemotherapy in France and the U.S.
Poxel SA PXL065 Non-alcoholic steatohepatitis (NASH) Phase 1b trial initiated enrolling 30 healthy subjects
Applied Molecular Transport AMT-101 Ulcerative Colitis Phase 1b trial initiated enrolling 20 adult subjects in Europe
NOXXON NOX-A12 in combination with radiotherapy Brain cancer Phase 1/2 trial recruiting newly diagnosed patients with brain tumors who would not benefit from the current standard of care of chemoradiotherapy and whose tumors cannot be fully resected by surgery in Germany
REVOLUTION Medicines RMC-4630 in combination with cobimetinib (Cotellic) relapsed/refractory solid tumors harboring specific genomic mutations Phase 1b/2 trial initiated
Momotaro-Gene MTG201 in combination with PD-1 inhibitor nivolumab (Opdivo) relapsed malignant pleural mesothelioma Phase 2 trial initiated enrolling 12 subjects with malignant mesothelioma who have failed front-line systemic platin-based chemotherapy at Baylor College of Medicine in Houston, Texas
Pulmatrix Pulmazole Allergic Bronchopulmonary Aspergillosis (ABPA) Phase 2 trial initiated enrolling 64 subjects with asthma
Graybug Vision, Inc. GB-102 macular edema (ME) secondary to Diabetic Macular Edema (DME) or Retinal Vein Occlusion (RVO) Phase 2a trial initiated enrolling 20 subjects at six centers in the U.S.
Alnylam Pharmaceuticals, Inc. patisiran transthyretin amyloidosis (ATTR amyloidosis) with cardiomyopathy Phase 3 study initiated enrolling 300 adult subjects with ATTR amyloidosis (hereditary or wild type) with cardiomyopathy
Apollo Endosurgery, Inc. Polypropylene Suture-Anchor Assembly pass and anchor suture in the gastrointestinal tract 510(k) Clearance granted by the FDA
Janssen Erleada metastatic castration-sensitive prostate cancer (mCSPC) Supplemental New Drug Application granted by the FDA

Merck

Eisai

Keytruda in combination with Lenvima advanced endometrial carcinoma Approval granted by the FDA
Xeris Pharmaceuticals GVOKE (glucagon) injection severe hypoglycemia Approval granted by the FDA