Parallel Walk Test

Chemomab Presentation at ACR Convergence 2023 Provides Further Support for Key Role of Its CCL24 Target in the Pathogenesis of Systemic Sclerosis

Retrieved on: 
Thursday, November 16, 2023

TEL AVIV, Israel, Nov. 16, 2023 /PRNewswire/ -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB) (Chemomab), a clinical stage biotechnology company focused on the discovery and development of innovative therapeutics for fibro-inflammatory diseases with high unmet need, today reported on its poster presentation at the American College of Rheumatology (ACR) Convergence 2023 conference. The study, which was conducted by Chemomab researchers working in collaboration with academic scientists, analyzed serum samples and clinical data from patients with systemic sclerosis (SSc) to assess the effect of the soluble protein CCL24 on the pathogenesis of SSc and its association with key aspects of SSc pathology. Chemomab's first-in-class monoclonal antibody, CM-101, is designed to neutralize CCL24 and normalize CCL24-driven fibro-inflammatory disease processes. CM-101 has been studied extensively in preclinical and patient models of SSc. Chemomab has an open IND in the U.S. for a Phase 2 trial of CM-101 in systemic sclerosis patients.

Key Points: 
  • Chemomab's first-in-class monoclonal antibody, CM-101, is designed to neutralize CCL24 and normalize CCL24-driven fibro-inflammatory disease processes.
  • Chemomab has an open IND in the U.S. for a Phase 2 trial of CM-101 in systemic sclerosis patients.
  • Systemic sclerosis is an autoimmune disease characterized by vascular injury and extensive tissue fibrosis of the skin and internal organs.
  • Using cell-based assays, the researchers showed that CCL24, alongside factors present in the SSc microenvironment, enhances the EndMT process.

Clario's Precision Motion Opal® technology powers University of Oxford breakthrough in Parkinson's Disease

Retrieved on: 
Friday, October 27, 2023

Clario's Precision Motion Opal® wearable sensor technology detects early Parkinson's disease (PD) progression in a University of Oxford study funded by UCB Pharma.

Key Points: 
  • Clario's Precision Motion Opal® wearable sensor technology detects early Parkinson's disease (PD) progression in a University of Oxford study funded by UCB Pharma.
  • Earlier detection supported by state-of-the-art sensor technology and machine learning is a promising discovery to aid in the expedited development of effective PD treatments.
  • Importantly, they found that the wearable technology detected disease progression in a significantly shorter timeframe than the traditional method.
  • "Time is crucial in clinical trials," said Professor Antoniades, Associate Professor of Neuroscience, Clinical Neurology at the University of Oxford.

Clario's Precision Motion Opal® technology powers University of Oxford breakthrough in Parkinson's Disease

Retrieved on: 
Friday, October 27, 2023

Clario's Precision Motion Opal® wearable sensor technology detects early Parkinson's disease (PD) progression in a University of Oxford study funded by UCB Pharma.

Key Points: 
  • Clario's Precision Motion Opal® wearable sensor technology detects early Parkinson's disease (PD) progression in a University of Oxford study funded by UCB Pharma.
  • Earlier detection supported by state-of-the-art sensor technology and machine learning is a promising discovery to aid in the expedited development of effective PD treatments.
  • Importantly, they found that the wearable technology detected disease progression in a significantly shorter timeframe than the traditional method.
  • "Time is crucial in clinical trials," said Professor Antoniades, Associate Professor of Neuroscience, Clinical Neurology at the University of Oxford.

Late-Breaking Data Confirms Safety of Axon Therapies' Innovative Heart Failure Procedure and Identifies Patients Most Likely to Benefit from SAVM Therapy

Retrieved on: 
Sunday, October 8, 2023

"SAVM utilizes a novel mechanism of action for treating heart failure, so we designed the REBALANCE-HF early feasibility trial to enable us to identify potential responder groups from a broad range of HFpEF patients.

Key Points: 
  • "SAVM utilizes a novel mechanism of action for treating heart failure, so we designed the REBALANCE-HF early feasibility trial to enable us to identify potential responder groups from a broad range of HFpEF patients.
  • The full treatment arm results confirmed the SAVM procedure was safe with no difference in procedure-related adverse events compared to the sham arm.
  • The improvements SAVM demonstrated in the responder group at 6 months were sustained in patients who have available 12-month data.
  • These data will be foundational to our efforts to bring this therapy to the patients who need it most."

Inozyme Pharma Announces Positive Interim Data from Ongoing Phase 1/2 Trials of INZ-701 in Adults with ENPP1 Deficiency and ABCC6 Deficiency (PXE)

Retrieved on: 
Tuesday, September 26, 2023

BOSTON, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (Nasdaq: INZY) (“Inozyme” or the “Company”), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation, today announced positive interim safety, pharmacokinetic (PK), pharmacodynamic (PD) and exploratory efficacy data from the Company’s ongoing Phase 1/2 clinical trials of INZ-701 in adults with ENPP1 Deficiency and ABCC6 Deficiency (PXE, pseudoxanthoma elasticum).

Key Points: 
  • For trial design details, please see the section entitled “INZ-701 in ENPP1 Deficiency Phase 1/2 Clinical Trial Design” below.
  • Exploratory biomarker data were collected throughout the study to provide evidence of the potential for disease modification with ongoing treatment with INZ-701.
  • For trial design details, please see the section entitled “INZ-701 in ABCC6 Deficiency Phase 1/2 Clinical Trial Design” below.
  • PK properties were consistent with those observed in the Phase 1/2 clinical trial in adults with ENPP1 Deficiency.

Drive and Walk Testing using Ultra-Portable Equipment

Retrieved on: 
Thursday, September 14, 2023

GAITHERSBURG, Md., Sept. 14, 2023 (GLOBE NEWSWIRE) -- GL Communications Inc., a global leader in telecom test and measurement solutions, addressed the press regarding their Drive and Walk Testing solution using GL’s vMobile™ equipment.

Key Points: 
  • GAITHERSBURG, Md., Sept. 14, 2023 (GLOBE NEWSWIRE) -- GL Communications Inc., a global leader in telecom test and measurement solutions, addressed the press regarding their Drive and Walk Testing solution using GL’s vMobile™ equipment.
  • “GL’s vMobile™ makes drive and walk testing simple and convenient.
  • Automated testing is achieved using vMobile™ scripts for placing and receiving calls as well as sending/recording audio during the established calls.
  • During the test, all results and events can be stamped with GPS coordinates using the onboard GPS receiver which includes external antenna to be used during drive testing while inside a vehicle.

Alnylam Announces Positive Outcome of FDA Advisory Committee Meeting on Patisiran for the Treatment of the Cardiomyopathy of ATTR Amyloidosis

Retrieved on: 
Wednesday, September 13, 2023

The CRDAC voted 9:3 that the benefits of patisiran outweigh its risks for the treatment of the cardiomyopathy of ATTR amyloidosis.

Key Points: 
  • The CRDAC voted 9:3 that the benefits of patisiran outweigh its risks for the treatment of the cardiomyopathy of ATTR amyloidosis.
  • The CRDAC’s vote, while not binding, will be considered by the FDA when making its decision regarding the potential expanded indication for patisiran.
  • Patisiran is the established name for ONPATTRO®, which is approved by the FDA for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults.
  • Patients should be referred to an ophthalmologist if they develop ocular symptoms suggestive of vitamin A deficiency (e.g., night blindness).

American Regent Announces Results From Phase 3 HEART-FID Trial with INJECTAFER®

Retrieved on: 
Saturday, August 26, 2023

American Regent, Inc., a Daiichi Sankyo Group company, today announced results from the phase 3 HEART-FID trial of INJECTAFER® (ferric carboxymaltose injection) for the treatment of iron deficiency in adult heart failure patients with reduced ejection fraction (HFrEF).

Key Points: 
  • American Regent, Inc., a Daiichi Sankyo Group company, today announced results from the phase 3 HEART-FID trial of INJECTAFER® (ferric carboxymaltose injection) for the treatment of iron deficiency in adult heart failure patients with reduced ejection fraction (HFrEF).
  • While there was a numerical improvement in the hierarchical composite endpoint, the trial did not meet statistical significance on the primary endpoint, which was a hierarchical composite of death and heart failure hospitalization at 12 months and change from baseline to 6 months in the 6-minute walk test distance.1 The HEART-FID trial was designed as a single pivotal study instead of two based upon a special protocol assessment with the U.S. Food and Drug Administration (FDA).
  • As a result, the study included a significance level for the final analysis of 0.0099 for the primary endpoint preserving the overall significance at 0.01.1 The safety profile of ferric carboxymaltose injection was consistent with previous reports with no new safety concerns identified.1
    Data from the HEART-FID study (NCT03037931) were presented today in a late-breaking research Hot Line session at the European Society of Cardiology Congress 2023.
  • Although there was a numerical improvement in the hierarchical composite endpoint, the study did not meet the pre-specified significance level of 0.0099.1
    “This trial addresses important clinical questions of diagnosing and treating iron deficiency in patients with heart failure at a specified dose regimen of ferric carboxymaltose to reduce rates of death and hospitalization as well as improve function,” said Robert Mentz, MD, Associate Professor in the Department of Medicine at Duke University School of Medicine , and Member of the Duke Clinical Research Institute and Clinical Lead for the trial.

Prothena Announces Phase 3 VITAL Clinical Trial Results Published in Blood Showing Survival Benefit in Patients with Mayo Stage IV AL Amyloidosis Treated with Birtamimab

Retrieved on: 
Tuesday, June 27, 2023

“AL amyloidosis is a rare and life-threatening disease in which patients have no treatment options despite the high fatality rate.

Key Points: 
  • “AL amyloidosis is a rare and life-threatening disease in which patients have no treatment options despite the high fatality rate.
  • For two secondary endpoints, birtamimab demonstrated statistically significant improvements over placebo in a post hoc assessment of patients with Mayo Stage IV AL amyloidosis.
  • In safety evaluations, the rates of treatment emergent adverse events (TEAEs) were balanced between treatment arms among patients with Mayo Stage IV AL amyloidosis (38 TEAEs in patients treated with birtamimab compared to 39 TEAEs in patients receiving placebo).
  • Cardiac disorder was the most common class of fatal TEAEs, which is consistent with patients who have AL amyloidosis.

PCTEL Automates Uplink Testing for Outdoor Public Safety Radio Networks

Retrieved on: 
Monday, March 27, 2023

PCTEL, Inc. (Nasdaq: PCTI), a leading global provider of wireless technology solutions, announced its latest innovative testing solution for P25 public safety radio networks with the industry’s first automated uplink drive and walk testing.

Key Points: 
  • PCTEL, Inc. (Nasdaq: PCTI), a leading global provider of wireless technology solutions, announced its latest innovative testing solution for P25 public safety radio networks with the industry’s first automated uplink drive and walk testing.
  • The majority of public safety radio coverage issues occur on the uplink, which is the signal from a handset to the radio site.
  • PCTEL’s solution is the first to incorporate uplink measurements into a drive or walk testing system.
  • PCTEL announced outdoor uplink testing at IWCE, the International Wireless Communications Expo.