Restoring blood flow to limbs is a challenging goal, given the minuteness of the peripheral vasculature. But there is a huge unmet need for patients with chronic limb-threatening ischemia (CLTI) – a severe form of peripheral artery disease in which patients face major amputation. Now, Limflow SA reports one-year data from the PROMISE I study shows its Percutaneous Deep Vein Arterialization System (pDVA) led to sustained amputation-free survival and wound healing in CLTI patients treated with the device.
Shares of Annovis Bio Inc. (NYSE:ANVS) leapt 127.3% to $60 May 21 on news that, following 25 days of treatment with its lead candidate, ANVS-401 (posiphen), 14 early Alzheimer's disease patients enrolled in its ongoing phase IIa study showed cognitive improvement of 22% vs. those who received placebo. Pending successful completion of the study, the company is targeting advancement to late-stage studies later this year.
VANCOUVER, British Columbia – Yiviva Inc., a pharmaceutical company focused on developing botanical drugs, has moved its lead candidate further into an international phase IIb trial for liver cancer and closer to an application through the FDA’s little-used botanicals pathway and a similar pathway in China. The company’s lead candidate, YIV-906, is intended for use in immunotherapy, chemotherapy and radiation therapy.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Annovis, Aurinia, Beigene, Immunitybio, J&J, Meiji Seika, Medivir, Onconova, Phosplatin, Poxel, Regulus.
CEO David Epstein said Black Diamond Therapeutics Inc. was “delighted” with phase I data testing BDTX-189 in advanced solid tumors harboring EGFR or HER2 alterations, but Wall Street seemed less so. Shares (NASDAQ:BDTX) closed at $13.93, down $8.30, or 37%.
Where Ilaris (canakinumab) failed, can Kineret (anakinra) succeed? Swedish Orphan Biovitrum AB is reporting that an investigator-initiated phase III study of its interleukin-1 (IL-1) blocker, Kineret, in 594 hospitalized COVID-19 patients with moderate or severe pneumonia, who had a poor prognosis, uncovered what appear to be dramatic benefits.
LONDON – The U.K. is launching a trial to investigate the potential use of seven different COVID-19 vaccines as boosters, to provide safety and immunogenicity data for if/when immune responses to initial vaccination wane and a revaccination campaign is needed later in the year. The trial, at 18 sites across the country, will recruit 2,886 participants who previously received two doses of either Astrazeneca plc or Pfizer Inc./Biontech SE’s COVID-19 vaccines.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acelrx, Annovis, Astellas, Black Diamond, Cantargia, Crescendo, Laurent, Merck, Obseva, Pyramid, Recardio, Seagen, Sensei, Transcenta, Xalud.
Boston Scientific Corp. presented late-breaking data at EuroPCR 2021 demonstrating positive procedural performance for its Acurate Neo2 aortic valve system, including low rates of paravalvular leakage (PVL) and permanent pacemaker implementation (PPI). The findings are good news, following the older Acurate Neo’s failure to demonstrate noninferiority to Medtronic plc’s Evolut R in the so-called SCOPE II study.
PARIS – Tecmoled SAS has just completed the initial testing phase for its wireless oximeter. A prototype has been tested over the past four months on 30 healthy subjects, aged 2 to 70 years, to measure oxygen saturation (SpO₂), heart rate and body temperature.
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