Medical robotics startup Noah Medical Inc. is conducting a first-in-human clinical trial to assess the safety and feasibility of its Galaxy system to improve lung cancer diagnosis. The device received U.S. FDA clearance on March 1 for use in bronchoscopic visualization and accessing patient airways for diagnostic and therapeutic purposes.
One company has developed a promising device and care model to reduce the exacerbations of chronic obstructive pulmonary disease (COPD) that often send patients to the hospital and contribute to accelerated disease progression. Patients who used a wearable remote cardiorespiratory monitoring device developed by Spire Inc. experienced a 64% decrease in cardiopulmonary-specific admissions in a study published in the International Journal of COPD.
Patients with Leber hereditary optic neuropathy who received bilateral injections of Gensight Biologics SA’s Lumevoq (lenadogene nolparvovec) are continuing to see statistically significant visual improvements three years into the phase III REFLECT trial, but the missed primary endpoint at 1.5 years, along with a series of manufacturing mishaps, have left the gene therapy’s approval prospects uncertain.
Optimism for the GoCAR-T program had perked somewhat after a mid-February update, but hopes were definitively dashed as Bellicum Pharmaceuticals Inc. made known March 15 its decision to quit the phase I/II study testing two prospects in heavily pretreated cancer. The Houston-based firm’s stock (NASDAQ:BLCM) closed at 43 cents, down 50%, as Wall Street reacted to news regarding the study, designed to test GoCAR-T cell prospects BPX-601 and BPX-603 when combined with the activating agent rimiducid, a lipid-permeable tacrolimus analogue.
Zhejiang Medicine Co. Ltd.’s subsidiary, Novocodex Biopharmaceuticals Inc., reported positive phase III study results for its humanized anti-HER2 monoclonal antibody-drug conjugate, ARX-788, in the treatment of patients with HER2-positive locally advanced or metastatic breast cancer in China.
Venus Medtech (Hangzhou) Inc. completed the enrollment of patients for a confirmatory clinical trial using its Liwen RF ablation system for the treatment of hypertrophic cardiomyopathy (HCM), reaching 128 patients in 20 hospitals in mainland China since January 2021.
A new blood test developed by Durin Technologies Inc. and Rowan-Virtua School of Osteopathic Medicine detected the presence of Alzheimer’s disease pathology in nearly all asymptomatic patients who went on to developed cognitive impairment or dementia, a study in the Journal of Alzheimer’s Disease found. The test uses eight autoantibody biomarkers to identify patients with the disease at pre-symptomatic, prodromal and mild-moderate stages of disease.
Acesion Pharma ApS reported that its lead drug candidate AP-30663 hit the primary endpoint of a phase II trial in atrial fibrillation (AF). The study had an adaptive design, which allowed for the recruitment of up to 108 patients experiencing an active AF episode, but the study investigators saw sufficient efficacy after a blinded evaluation of just 63 patients to terminate at that point. The study, which began shortly before the COVD-19 pandemic, had been underway for three years at that stage.
Les Laboratoires Servier SAS is touting its phase III win with vorasidenib as the first major advance in decades for low-grade glioma, with the trial called Indigo scoring statistical significance on two measures against residual or recurrent isocitrate dehydrogenase-mutant disease. The Suresnes, France-based firm said Indigo met the primary endpoint of progression-free survival (PFS) and the key secondary endpoint of time to next intervention (TTNI). The results of the prespecified interim analysis proved not only statistically significant but also clinically meaningful in PFS and TTNI.
Astellas Pharma Inc.’s fezolinetant met all four co-primary endpoints in the pivotal phase III SKYLIGHT 1 study for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. An oral, nonhormonal compound, fezolinetant targets the neurokinin 3 receptor to reduce the frequency and severity of moderate to severe VMS, or hot flashes, due to menopause.
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