Ocular Therapeutix (NSDQ:OCUL) said today that its post-surgical ocular pain reliever, Dextenza, met both primary endpoints in a pivotal trial for the treatment of post-surgical ocular inflammation and pain. The product is a bioresorbable intracanalicular insert, designed for drug release to the ocular surface for up to 30 days. The randomized, double-masked study enrolled 438 patients who were […]
Clinical Trials
Stanford uses CRISPR to correct sickle cell, human trials planned
Researchers from the Stanford University School of Medicine have reportedly used CRISPR, a gene-editing tool, to repair the gene that causes sickle cell disease. The team is planning the 1st human clinical trial using this technique to correct cells with sickle cell disease, according to Reuters. “What we’ve finally shown is that we can do it. It’s […]
SanBio touts 1-year data on stem cell transplant for stroke
SanBio Inc. (TYO:4592) released 1-year interim data from the phase 1/2a, open-label, single-arm dose escalation study of its intracerebral stem cell implant designed for stroke patients. The Mountain View, Calif.-based company touted the results, which indicated that itsSB623 stem cell treatment was generally safe, well-tolerated and associated with improved motor functions in patients suffering with chronic impairment following […]
Mast Therapeutics touts interim data from pulmonary hypertension study
Mast Therapeutics (NYSE:MSTX) touted interim data from a Phase II study of its AIR001 candidate in patients with pulmonary hypertension (PH) and PH associated with heart failure with preserved ejection fraction. Positive interim results from the ongoing trial were published in the Journal of Clinical Investigation. The San Diego-based company enrolled 50 patients to study its nebulized […]
Stellarex drug-coated balloon from Spectranetics bests PTA at 1 year
The Stellarex drug-coated balloon made by Spectranetics (NSDQ:SPNC) beat out percutaneous transluminal angioplasty in the 300-patient Illumenate pivotal study reported today at the 2016 Transcatheter Cardiovascular Therapeutics Symposium. The study followed a complex group of patients over 12 months to evaluate the low-dose balloon’s efficacy and safety. Nearly 50% of the patient population had diabetes, […]
NanoViricides inks deal for shingles study
NanoViricides, Inc. (NYSE:NNVC) said today that it inked a deal with SUNY Upstate Medical University for the evaluation of its nanovirivides drug candidates against varicella zoster virus, also called the shingles virus. The goal of these in vitro, ex vivo, and in vivo studies will be to help select a clinical drug development candidate for toxicology and safety evaluation […]
FDA OKs stem cell-gene therapy trial for ALS
The FDA approved a combination stem cell-gene therapy clinical trial to test the treatment’s ability to slow the progression of amyotrophic lateral sclerosis. It’s the 1st clinical trial to use neural stem cells to deliver a particular protein in the hopes of slowing ALS progression, according to researchers at the ALS clinic at Cedars-Sinai Medical […]
Litmus Health looks to bring wearables to drug development
Litmus Health said yesterday that it launched its clinical data science platform into public beta. The company hopes to use big data from wearables and connected devices to help inform endpoints for Phase I & II clinical trials. The goal of its platform, according to Litmus, is to get pharmaceuticals to market faster by putting […]
Monaghan Medical touts Aerobika study
Monaghan Medical yesterday touted data from a 6-month retrospective study showing that its Aerobika device reduced drug use for treatment of chronic obstructive pulmonary device. The Syracuse, N.Y.-based company says its oscillating positive expiratory pressure therapy device is designed to expand the airways, help expel mucus to the upper airways and aid in drug deposition. The […]
Targazyme wins FDA clearance for Phase II bone marrow stem cell study
Targazyme said today that it will begin enrolling patients in a Phase II clinical study to evaluate TZ101-fucosylated bone marrow stem cells in cancer patients, after the FDA granted the San Diego-based company investigational new drug clearance. The treatment is designed to use blood-forming stem cells from bone marrow to restore the body’s ability to make blood […]