LONDON – Three patients with complete spinal cord injury are able to walk independently after having specialized electrodes implanted below their lesions. The details were published in Nature Medicine on Feb. 7. This is a significant new milestone for the researchers at École polytechnique fédérale de Lausanne (EPFL), Switzerland, who in 2018 delivered proof that electrical stimulation can reactivate spinal neurons, in that case in three patients with partial spinal cord injury. “Here for the first time, we have developed purpose-made technology in order to precisely stimulate the spinal cord to restore movement after paralysis,” said Gregoire Courtine, professor of spinal cord repair at EPFL.
The pivotal, multicenter trial commissioned by Envveno Medical Corp. is intended to show its first-in-class Venovalve implant is safe and effective for treating deep venous chronic venous insufficiency (CVI), which occurs when damaged valves inside the veins of the leg prevent blood from flowing up the leg and into the heart and lungs.
San Francisco-based startup Mirvie Inc. has released data demonstrating how its RNA platform technology can predict preterm birth. The research, presented at the Society for Maternal-Fetal Medicine 42nd Annual Pregnancy Meeting (SMFM 2022), showed the company’s test predicted the condition months before symptoms occurred and identified biological pathways that drive changes in pregnancy.
Bionomics Ltd.’s U.S. debut last December, when the firm raised about $23 million through the sale of American depositary shares, called new attention to the Australian firm and its prospects in social anxiety disorder (SAD) and post-traumatic stress disorder (PTSD).
Citing potential confounding factors, Vanda Pharmaceuticals Inc. is hoping further analysis might explain the top-line miss for its phase III study testing tradipitant in gastroparesis, hinting that regulatory submissions could still be in the offing. Investors, unsurprisingly, were less optimistic, sending shares of the Washington-based company (NASDAQ:VNDA) down nearly 18% to close Feb. 4 at $12.03.
University of Edinburgh spinoff Biocaptiva Ltd. is taking its cell free DNA (cfDNA) capture device to clinical trials in 2022 following promising preclinical results. The company’s platform technology is designed to increase the quantity of cfDNA available for liquid biopsy testing. Current liquid biopsy practices obtain cfDNA via a venous blood draw but the concentration of tumor-derived ctDNA can be too low for comprehensive testing. Biocaptiva’ device emerged from research at the University of Edinburgh investigating liquid biopsy technologies.
The dosing by Vincerx Pharma Inc., in mid-December of last year, of the first patient in the phase I study with VIP-152 marked the second experiment begun by the company in 2021, and added oomph to the already-growing renewal of interest in CDK9 as a therapeutic target.
The ultra-rare skin disease X-linked hypohidrotic ectodermal dysplasia (XLHED) can be a heavy burden for children, affecting structures in the skin including sweat glands, respiratory glands, and hair as well as teeth. Though lacking a specific treatment to date, a pivotal clinical trial planned by the Geneva-based nonprofit Esperare Foundation and Pierre Fabre SA could now help bring one about.
The FDA has placed Logicbio Therapeutics Inc.’s phase I/II clinical trial of LB-001, an investigational AAV genome-editing therapy for treating pediatric patients with methylmalonic acidemia (MMA), on a clinical hold. So far, four patients have been dosed in the study and two have had serious adverse events related to the candidate, the company’s lead asset.
LONDON – The first human challenge study of SARS-CoV-2 infection has reported initial results, showing it is safe to infect healthy volunteers with the virus in controlled conditions, and paving the way for the model to be used to accelerate clinical trials of COVID-19 vaccines, antivirals and diagnostics.
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