Odds ratio

CareJourney Analysis Shows Breast Cancer Screenings Dropped During COVID-19, but Women Cared for by Physicians in Value-Based Care Arrangements Were Significantly More Likely to Be Screened

Retrieved on: 
Martedì, Maggio 17, 2022

However, patients cared for by physicians participating in value-based care (VBC) arrangements were far more likely to be screened for breast cancer than those who were not enrolled in a VBC program.

Key Points: 
  • However, patients cared for by physicians participating in value-based care (VBC) arrangements were far more likely to be screened for breast cancer than those who were not enrolled in a VBC program.
  • In 2018-2019, an average of 4,513,772 women received a mammogram, between 2020-2021; the annual average was reduced to 4,014,750.
  • Recent improvements in cancer patient outcomes have come in part from timely preventive cancer screenings, such as mammograms.
  • The CareJourney breast cancer screening analysis was performed by using 100 percent of Medicare FFS population data (Part A, B, and D).

Synairgen Presents Detailed Analysis of Phase 3 SPRINTER Trial Evaluating SNG001 in Hospitalised COVID-19 Patients at ATS 2022

Retrieved on: 
Lunedì, Maggio 16, 2022

The trial recruited a total of 623 patients who were randomised to receive SNG001 (n=309) or placebo (n=314) on top of standard of care (SOC).

Key Points: 
  • The trial recruited a total of 623 patients who were randomised to receive SNG001 (n=309) or placebo (n=314) on top of standard of care (SOC).
  • Synairgen announced in February 2022 that the Phase 3 SPRINTER trial did not meet the primary endpoints of discharge from hospital and recovery.
  • The full analysis of the Phase 3 SPRINTER trial data will be submitted for publication in a peer-reviewed journal.
  • This was reported as 27.1% in the topline analysis in February 2022 but changed between 35- and 90-day database lock.

Data from Independent, Pooled Analysis Show Significantly Improved Risk Predictions Over Clinical Variables for TissueCypher® Barrett’s Esophagus Test and Ability to Identify Patients at High Risk of Progressing to Esophageal Cancer

Retrieved on: 
Mercoledì, Aprile 27, 2022

In clinical practice, the majority of BE patients who develop esophageal cancer are diagnosed as NDBE at their baseline endoscopy.

Key Points: 
  • In clinical practice, the majority of BE patients who develop esophageal cancer are diagnosed as NDBE at their baseline endoscopy.
  • In the manuscript titled, Prediction of Progression in Barretts Esophagus Using a Tissue Systems Pathology Test: A Pooled Analysis of International Multicenter Studies, Iyer et al.
  • Further, a TissueCypher high-risk score was associated with a strong (Odds Ratio (OR)=14.3) independent risk of progression in NDBE patients.
  • The TissueCypher Barretts Esophagus test is Castles precision medicine test designed to predict future development of high-grade dysplasia (HGD) and/or esophageal cancer in patients with Barretts esophagus (BE).

Results Published for Seraph 100 Treatment of COVID-19 Confirm Survival Benefit Signal

Retrieved on: 
Giovedì, Aprile 21, 2022

The study includes analysis of 106 patients admitted to the ICU, 53 treated with Seraph 100 vs. 53 controls.

Key Points: 
  • The study includes analysis of 106 patients admitted to the ICU, 53 treated with Seraph 100 vs. 53 controls.
  • We are very pleased that, compared to contemporaneous controls, there was a strong signal of survival benefit for COVID-19 patients treated with the Seraph 100, said ExThera Medical Chairman and CEO Robert Ward.
  • We are encouraged that these results show that the Seraph 100 therapy is safe and well tolerated, said ExThera Medical Scientific Advisory Chair Lakhmir Chawla, MD.
  • These results justify multicenter randomized controlled trials to study the Seraph 100 in various critically ill patient populations suffering from sepsis.

Jeune Aesthetics Announces Positive Clinical Phase 1 (PEARL-1 Study) Efficacy Results for KB301, an Investigational Gene-based Treatment Designed to Address the Underlying Biology of Aging Skin

Retrieved on: 
Martedì, Marzo 22, 2022

Skin aging is caused by both intrinsic and extrinsic factors, leading to progressive loss of dermal collagen and other proteins.

Key Points: 
  • Skin aging is caused by both intrinsic and extrinsic factors, leading to progressive loss of dermal collagen and other proteins.
  • KB301 leverages Krystals proprietary gene delivery platform to restore protein production and rebuild the underlying extracellular matrix structure.
  • The Phase 1 dose-ranging trial evaluated the safety, tolerability, and initial efficacy of intradermal injections of KB301 in adult subjects aged 18-75 (NCT04540900).
  • Complete results from Cohort 1 focused on safety were presented at the 2021 Society for Investigative Dermatology (SID) Annual Meeting.

Incyte Announces Positive CHMP Opinion for Ruxolitinib (Jakavi®) for the Treatment of Acute and Chronic Graft-Versus-Host Disease

Retrieved on: 
Venerdì, Marzo 25, 2022

The CHMP positive opinion was based on data from the Phase 3 REACH2 and REACH3 clinical studies, in which ruxolitinib demonstrated superiority versus best available therapy (BAT) in patients with steroid-refractory and steroid-dependent acute and chronic GVHD, respectively.

Key Points: 
  • The CHMP positive opinion was based on data from the Phase 3 REACH2 and REACH3 clinical studies, in which ruxolitinib demonstrated superiority versus best available therapy (BAT) in patients with steroid-refractory and steroid-dependent acute and chronic GVHD, respectively.
  • The CHMP opinion to recommend the use of ruxolitinib in acute and chronic GVHD is now being reviewed by the European Commission, which has the authority to grant marketing authorization for medicinal products in the European Union.
  • The EC will review the CHMP recommendations and is expected to make a final decision within approximately 2 months.
  • Your healthcare provider will do a blood test to check your blood counts before you start Jakafi and regularly during your treatment.

Assessing Complex Endovascular Aneurysm Repair

Retrieved on: 
Mercoledì, Marzo 16, 2022

Thoraco-abdominal aortic aneurysm repair is among the most complex and serious operations in the realm of surgery.

Key Points: 
  • Thoraco-abdominal aortic aneurysm repair is among the most complex and serious operations in the realm of surgery.
  • Endovascular repair of these aneurysms is now established as a viable alternative to open surgical repair, and, according to principal author Gustavo Oderich, MD, from the University of Texas Health Science Center at Houston, studies have demonstrated superior results to open repair.
  • However, despite many technical improvements in complex endovascular repairs, the procedure remains technically demanding with significant risks.
  • As reported in the March 2022 edition of the Journal of Vascular Surgery, the aim of this study was to review the incidence of IAEs and its impact on outcomes of fenestrated-branched endovascular aneurysm repair (FB-EVAR) for the treatment of complex aortic aneurysms.

Ipsen: New Patient-Reported Data Demonstrated High Satisfaction Levels and Fewer Patients Reporting Injection-site Pain with Somatuline® Autogel®/Somatuline® Depot (lanreotide)

Retrieved on: 
Martedì, Marzo 8, 2022

Presentations include data from the PRESTO 2 and HomeLAN surveys which demonstrated patient-reported benefits when administering Somatuline Autogel/Somatuline Depot (lanreotide).

Key Points: 
  • Presentations include data from the PRESTO 2 and HomeLAN surveys which demonstrated patient-reported benefits when administering Somatuline Autogel/Somatuline Depot (lanreotide).
  • These include fewer patients reporting experiencing injection-site pain and high levels of injection experience satisfaction when participating in patient support programs (PSP), respectively.
  • These data will help healthcare professionals better understand the impact of injection-site pain, an important consideration to discuss with patients when making treatment decisions.
  • Furthermore, after training, patients on stable dose can administer Somatuline Autogel independently (self or partner), where approved.

Vifor Pharma and Angion report topline results from phase-II GUARD trial of ANG-3777 in cardiac surgery associated acute kidney injury

Retrieved on: 
Venerdì, Dicembre 10, 2021

53 LR

Key Points: 
  • 53 LR
    Vifor Pharma and Angion Biomedica Corp. (NASDAQ: ANGN) today announced results from the exploratory phase-II GUARD trial of Angions ANG-3777 in patients undergoing cardiac surgery involving cardiopulmonary bypass at risk for developing acute kidney injury (CSA-AKI).
  • However, Angion and Vifor Pharma continue to review the data, based on the signal demonstrated in the clinically-relevant MAKE90 secondary endpoint.
  • Angion and Vifor Pharma are evaluating the full data set from the Phase 2 GUARD trial in patients at risk for acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass (CSA-AKI).
  • Angion and Vifor Pharma are evaluating the full data set from the phase-II GUARD trial in patients at risk for acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass (CSA-AKI).

Angion and Vifor Pharma Report Topline Results from Phase 2 GUARD Trial of ANG-3777 in Cardiac Surgery-Associated Acute Kidney Injury

Retrieved on: 
Giovedì, Dicembre 9, 2021

UNIONDALE, N.Y. and ST. GALLEN, Switzerland, Dec. 09, 2021 (GLOBE NEWSWIRE) -- Angion Biomedica Corp. (NASDAQ:ANGN) and Vifor Pharma today announced results from the exploratory Phase 2 GUARD trial of Angion’s ANG-3777 in patients undergoing cardiac surgery involving cardiopulmonary bypass at risk for developing acute kidney injury (CSA-AKI). The trial did not meet its primary endpoint of percentage increase in serum creatinine based upon the area under the curve (AUC). However, Angion and Vifor Pharma continue to review the data based on the signal demonstrated in the clinically relevant MAKE90 secondary endpoint.

Key Points: 
  • However, Angion and Vifor Pharma continue to review the data based on the signal demonstrated in the clinically relevant MAKE90 secondary endpoint.
  • Topline results from the Phase 2 GUARD trial appear below.
  • Angion and Vifor are evaluating the full data set from the Phase 2 GUARD trial in patients at risk for acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass (CSA-AKI).
  • Angion and Vifor are evaluating the full data set from the ANG-3777 Phase 2 GUARD trial in patients at risk for acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass (CSA-AKI).