Just a day after the world's first approval of Merck & Co. Inc.'s oral antiviral for COVID-19 positioned it to offer a new way to keep Britons at high risk of severe disease out of the hospital, Pfizer Inc. is stopping a phase II/III trial of its oral antiviral, Paxlovid, early for "overwhelming efficacy" in a similar group. Interim results showed that combining the drug, also known as PF-07321332, with ritonavir reduced the risk of hospitalization or death for adults with mild to moderate COVID-19 but at high risk of severe disease by 89% vs. placebo.
Despite the morbidity associated with coronary artery bypass graft, this procedure has never been entirely displaced by percutaneous coronary intervention. The results from the latest in a series of studies does not seem to help the case for drug-eluting stents (DES) for patients with three-vessel disease, as the data from this study failed to demonstrate non-inferiority for DES devices implanted with the help of fractional flow reserve measurement to ensure optimal stent placement.
Hot off the heels of a $45 million series B financing raise, Activ Surgical Inc. has completed the first clinical trial evaluating its Activinsights augment reality (AR)-based software suite and Activsight imaging module. The safety and feasibility study, carried out with The University of Texas Health Science Center at Houston (UTHealth Houston) is the first of several trials the Boston-based company is planning in 2021.
Sangamo Therapeutics Inc. rolled out pleasing preliminary data from the first four patients treated in the phase I/II study known as Staar, evaluating isaralgagene civaparvovec, or ST-920, a gene therapy for Fabry disease. Results as of the Sept. 17, 2021, cutoff date from the four patients in the first two dose cohorts showed that the drug was generally well-tolerated, and all four patients exhibited above normal alpha-galactosidase A activity.
Though Wall Street may not have caught on to the value of Clene Inc.’s phase II results with gold nanocrystal suspension CNM-Au8 in amyotrophic lateral sclerosis (ALS), CEO Rob Etherington said his firm is “truly excited” about the data, which bode well for the next stage of development, already underway.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 7 Hills, Aldeyra, Astrazeneca, Aurinia, Axon, Clene, Compass, Equillium, Huyabio, Hyloris, Metacrine, Oncoresponse, Primmune, Rhythm, Uniqure, Vicore.
A brighter future awaits radiotherapy if Flash and LIGHT live up to their promise. Announcements made last week by Varian Medical Systems and Advanced Oncotherapy plc indicate results should be seen soon. Varian reported that the first human clinical trial of Flash, Fast-01, completed its treatment phase last week at the Cincinnati Children’s/University of Cincinnati Health Proton Therapy Center. Advanced Oncotherapy plc presented results from a modeling study of Linac for Image Guided Hadron Therapy (LIGHT) technology at the American Society for Radiation Oncology (ASTRO) 2021 Annual Meeting demonstrating that LIGHT enables both the high, super-quick dose delivery of Flash and good conformality of dose delivery to tumor tissue.
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