The U.S. Preventive Services Task Force (USPSTF) appears on the verge of expanding colorectal cancer screening to individuals ages 45 to 49, based on its latest draft recommendations. If it does, Exact Sciences Corp. is ready. A study in Cancer Prevention Research demonstrated that the Madison, Wis.-based company's Cologuard multitarget stool DNA test had better than 95% specificity in individuals with nonadvanced precancerous lesions or negative findings on colonoscopy.
Opticyte Inc., a medical device startup, is planning the first clinical trial of its cellular oxygen monitor, a new device that could help emergency physicians diagnose sepsis faster and prevent organ failure. The prospective, observational trial is set to launch in mid-2021.
With the table set for phase III data due next month from a trial testing Travere Therapeutics Inc.’s sparsentan against focal segmental glomerulosclerosis (FSGS), investor appetite grows ever sharper for prospects in kidney disease.
Arcus Biosciences Inc., in a presentation on the opening day of the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI), reported a 41% objective response rate across the first four cohorts in its phase I dose-escalation study of AB-680, a small-molecule CD73 inhibitor for treating metastatic pancreatic cancer. The data also showed 88% of patients experienced at least some shrinkage of their lesions.
Medtronic plc reported that the first patient has been enrolled in the Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) study its trial evaluating the safety and efficacy of adaptive deep brain stimulation (aDBS) in patients with Parkinson's disease (PD). This type of stimulation is an investigational feature of the Percept PC device that could be enabled if approved.
Citing a lack of efficacy from adding its complement inhibitor Ultomiris (ravulizumab) to best supportive care for patients hospitalized with severe COVID-19, Alexion Pharmaceuticals Inc. paused further enrollment in a global phase III study of the drug. The move, recommended by the trial's independent data monitoring committee, suggested Ultomiris may soon join the list of other therapeutics once tested against COVID-19 but now no longer.
Nantkwest Inc. and privately held Immunitybio Inc. trotted out positive early interim results from their advanced metastatic pancreatic cancer studies showing median survival rates more than double the historic rates: eight month’s survival compared to only three. “Anything beyond three months has an impact,” Patrick Soon-Shiong, Immunitybio’s CEO and Nantkwest’s executive chairman, told BioWorld, with understatement about one of the toughest to manage indications in medicine.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alexion, Ampio, Atyr, Bicycle, Knopp, Kyorin, Mirum, Nantkwest, Organogenesis, United, Verona.
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