Blood purification company ExThera Medical Corporation stated on Tuesday that critically-ill COVID patients treated with the Seraph 100 Microbind Affinity Blood Filter (Seraph 100) have completed enrollment under the PURIFY OBS observational study led by the US DOD.
The PURIFY RCT is a multicentre randomized controlled trial studying blood purification for the treatment of pathogen associated shock. The multicentre RCT trials are rare in the field of extracorporeal therapy and require robust signals of efficacy. It is expected to begin enrollment in early 2022It is expected that the positive clinical results observed in PURIFY OBS will continue during PURIFY RCT.
In addition, the complete PURIFY observational study is expected to be published during Q1 2022. The observations included dramatic improvement in survival and reduction in median ICU length of stay for patients treated with the Seraph 100 vs controls.
According to the company, physicians across the US are using the Seraph 100 under Emergency Use Authorization from the US Food and Drug Administration to treat COVID-19 patients admitted to the ICU with confirmed or imminent respiratory failure. In 2019, the Seraph 100 was granted CE mark in the EU for the reduction of bloodstream pathogens. As a patient's blood flows through the Seraph 100 filter, it passes over beads with receptors that mimic the receptors on human cells that pathogens target when they invade the body. Harmful substances are quickly captured and adsorbed onto the surface of the beads and are thereby subtracted from the bloodstream.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval