Vascular remodelling in the embryo

Alucent Biomedical Receives Regulatory Approval for Second U.S. Clinical Study

Retrieved on: 
Tuesday, November 7, 2023
Medical Devices, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Trial of the century, Ioctl, AVF, Vascular remodelling in the embryo, Physician, Kidney failure, AV, IDE, Dialysis, Arteriovenous fistula, Fistula, Patient, Activate, Medical device

Alucent Biomedical Inc. today announced that the U.S. Food & Drug Administration (FDA) granted an Investigational Device Exemption (IDE) for a U.S. clinical study of its AlucentNVS technology for promoting the maturation of arteriovenous fistulas (AVF) in patients requiring hemodialysis.

Key Points: 
  • Alucent Biomedical Inc. today announced that the U.S. Food & Drug Administration (FDA) granted an Investigational Device Exemption (IDE) for a U.S. clinical study of its AlucentNVS technology for promoting the maturation of arteriovenous fistulas (AVF) in patients requiring hemodialysis.
  • The milestone follows Alucent’s first IDE approval from the FDA, which was granted in August 2023.
  • AlucentNVS combines an intravascular device with a photochemical process to link structural proteins in the wall of a blood vessel to control vascular remodeling.
  • The intervention is designed to promote patency of the vessel’s lumen and establish sustained improvement of blood flow.

Humacyte Announces Publication of Biological Mechanism Explaining Low Rates of Infection Observed in Clinical Study of Human Acellular Vessel™ (HAV™)

Retrieved on: 
Thursday, August 3, 2023
Infection, Neutrophil, Amputation, Clinical trial, Quality of life, Sale, Sepsis, Dialysis, Polytetrafluoroethylene, Journal, Patient, HUMA, Peripheral artery disease, Vascular remodelling in the embryo, FDA, HAV, Trauma, Death, Pharmaceutical industry, Synthetic

DURHAM, N.C., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announces the publication of controlled in vitro studies in the Journal of Vascular Surgery – Vascular Science describing the scientific basis for the significantly lower rates of infection observed in a clinical trial of the investigational HAV compared to synthetic expanded polytetrafluoroethylene (ePTFE) grafts. The in vitro study results show the HAV had more host cell infiltration than ePTFE grafts, and that the biocompatibility of the HAV supported neutrophil viability and function, each of which may explain the HAV’s superior resistance to bacterial infection versus ePTFE grafts observed in the clinical trial. 

Key Points: 
  • Neutrophils are a critical cell type for host defense against infection.
  • Data analyzed from a comparative clinical trial demonstrated that the HAV had a significantly lower infection rate than ePTFE grafts.
  • A biological rationale for this finding was then shown through explant histopathology and cell experiments which demonstrated that the HAV, but not ePTFE grafts, supported neutrophil viability and function.
  • The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

Alucent Biomedical Wins FDA Approval for U.S. Clinical Study

Retrieved on: 
Wednesday, August 2, 2023
Medical Devices, FDA, Health, Clinical Trials, Cardiology, Biotechnology, PAD, Trial of the century, Standard of care, Patient, Vascular disease, Coronary, Peripheral artery disease, Vascular remodelling in the embryo, Arteriovenous fistula, IDE, AVF, Medical imaging

Alucent Biomedical Inc. today announced that the U.S. Food & Drug Administration granted an Investigational Device Exemption (IDE) for a U.S. clinical study of AlucentNVS, a unique light-activated, drug-coated balloon catheter technology.

Key Points: 
  • Alucent Biomedical Inc. today announced that the U.S. Food & Drug Administration granted an Investigational Device Exemption (IDE) for a U.S. clinical study of AlucentNVS, a unique light-activated, drug-coated balloon catheter technology.
  • AlucentNVS combines an intravascular device with a photochemical process to link structural proteins in the wall of a blood vessel to control vascular remodeling.
  • The intervention is designed to promote patency of the vessel’s lumen and establish sustained improvement of blood flow.
  • “IDE approval by the FDA’s Division of Coronary and Peripheral Interventional Devices is another validation of our novel approach to treating vascular disease,” said Dr. Myles Greenberg, CEO of Alucent Biomedical.

Keros Therapeutics Presents Preclinical and Clinical Data from its KER-012 Program at the American Thoracic Society International Conference

Retrieved on: 
Monday, May 22, 2023
GDF11, Mouse, Endothelial dysfunction, Heart failure, TGF, Heart, PAH, Serum, ATS, Matrix metalloproteinase inhibitor, Cardiac fibrosis, SMAD, Pharmacokinetics, Woman, IL-6, Research, Part, Inflammation, Biomarker, American Thoracic Society, SMAD2, Administration, TAC, MARCO, Asilomar International Conference on Climate Intervention Technologies, Patient, Vascular remodelling in the embryo, Orthostatic hypertension, Therapy, Hypoxia, Conference, Endothelium, Safety, KROS, Pharmaceutical industry, Medical device, Extractive metallurgy, Vaccine, Trapping, Fibrosis

“We are pleased to present clinical and preclinical data from our KER-012 program at the ATS conference this year.

Key Points: 
  • “We are pleased to present clinical and preclinical data from our KER-012 program at the ATS conference this year.
  • The preclinical presentations demonstrate observed ligand selectivity of KER-012 and changes in inflammation and fibrosis in models of PAH and cardiovascular diseases.
  • Keros reported preliminary topline data from the Part 1 single ascending dose portion of the trial in May 2022, and additional preliminary clinical data from the Part 2 multiple ascending dose portion of the trial in September 2022.
  • HPAECs and HPASMCs were treated with activin A, GDF11, or bone morphogenetic protein 9 (“BMP9”) in the presence of KER-012.

Idorsia submits a New Drug Application to the US FDA for aprocitentan for the treatment of patients with difficult-to-control hypertension

Retrieved on: 
Tuesday, December 20, 2022
ETA, Fibrosis, IDIA, ETB, Randomized controlled trial, Moyamoya disease, Food, End organ damage, MD, American Heart Association, BP, Endothelin 1, Death, NDA, Risk, Johnson & Johnson, Patient, Science, Janssen Biotech, Aldosterone, Vascular remodelling in the embryo, US Foods, Safety, Heart failure, FDA, Hypertension, Janssen Pharmaceuticals, Obesity, Chronic kidney disease, Lancet, AHA, Blood pressure, Diabetes, Endothelial dysfunction, Hypertrophy, Kidney, Pharmaceutical industry

In the Phase 3 registration study, PRECISION, aprocitentan showed statistically significant and clinically meaningful reduction in blood pressure (BP) which was maintained for up to 48 weeks when added to combination background antihypertensive therapy in patients with resistant hypertension.

Key Points: 
  • In the Phase 3 registration study, PRECISION, aprocitentan showed statistically significant and clinically meaningful reduction in blood pressure (BP) which was maintained for up to 48 weeks when added to combination background antihypertensive therapy in patients with resistant hypertension.
  • In PRECISION, aprocitentan was generally well tolerated with no major safety concerns.
  • By targeting a currently unopposed pathophysiologic pathway, aprocitentan represents a potential novel, effective, and well-tolerated treatment for difficult-to-control hypertension.
  • Idorsia is developing aprocitentan together with Janssen Biotech Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

EQS-News: invIOs GmbH: APEIRON Respiratory Therapies announces positive results from Phase I trial of inhaled APN01

Retrieved on: 
Monday, November 7, 2022
Medical University of Vienna, Blood pressure, Severe acute respiratory syndrome coronavirus 2, Heart, Ageing, MAD, SADS, Death, Degenerative disease, Vascular remodelling in the embryo, Kidney disease, Science, Principal, Safety, Adult, APN01, Department, Toxicity, Ventilation, COVID-19, Gene expression, ACE, Acute respiratory distress syndrome, Medical school, CEO, Inhalation, Lung, Pharmacology, PAH, Hypertensive emergency, Patient safety, ACE2, RAAS, Hydrolysis, Inflammation, Liver, Mads, Respiratory disease, Achievement, Kidney, Immunotherapy, Patient, Gesellschaft mit beschränkter Haftung, Pharmacokinetics, Administration, Vaccine, Pharmaceutical industry, Arester Earl

In a completed double-blind, placebo-controlled Phase 2 trial, intravenously administered APN01 showed potential clinical benefit against COVID-19.

Key Points: 
  • In a completed double-blind, placebo-controlled Phase 2 trial, intravenously administered APN01 showed potential clinical benefit against COVID-19.
  • With the current trial of inhaled APN01 and our previous Phase 2 trial using intravenous administration in COVID-19, we have shown that APN01 is a safe and well tolerated potential treatment approach for a number of respiratory diseases.
  • More information on the demerger of AResT and invIOs from APEIRON Biologics AG can be found on the invIOs website here .
  • The first EPiC-based candidate, APN401, is currently being evaluated in a clinical Phase 1b trial in patients with advanced solid tumors.

APEIRON Respiratory Therapies announces positive results from Phase I trial of inhaled APN01

Retrieved on: 
Thursday, November 3, 2022
Medical University of Vienna, Blood pressure, Severe acute respiratory syndrome coronavirus 2, Heart, Ageing, MAD, SADS, Death, Degenerative disease, Vascular remodelling in the embryo, GLOBE, Kidney disease, Science, Principal, Safety, Adult, APN01, Department, Toxicity, Ventilation, COVID-19, Gene expression, ACE, Acute respiratory distress syndrome, Medical school, CEO, Inhalation, Lung, Pharmacology, PAH, Hypertensive emergency, Patient safety, ACE2, RAAS, Hydrolysis, Inflammation, Liver, Mads, Respiratory disease, Achievement, Kidney, Immunotherapy, Patient, Gesellschaft mit beschränkter Haftung, Pharmacokinetics, Administration, Vaccine, Pharmaceutical industry, Arester Earl

In a completed double-blind, placebo-controlled Phase 2 trial, intravenously administered APN01 showed potential clinical benefit against COVID-19.

Key Points: 
  • In a completed double-blind, placebo-controlled Phase 2 trial, intravenously administered APN01 showed potential clinical benefit against COVID-19.
  • With the current trial of inhaled APN01 and our previous Phase 2 trial using intravenous administration in COVID-19, we have shown that APN01 is a safe and well tolerated potential treatment approach for a number of respiratory diseases.
  • The double-blind, placebo-controlled, dose-escalation study was designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of inhaled APN01.
  • The first EPiC-based candidate, APN401, is currently being evaluated in a clinical Phase 1b trial in patients with advanced solid tumors.

ALTAVANT SCIENCES PRESENTS DATA SHOWING POTENTIAL FOR COMBINATION OF RODATRISTAT ETHYL AND AMBRISENTAN IN MODEL OF PULMONARY ARTERIAL HYPERTENSION

Retrieved on: 
Friday, May 6, 2022
Forward-looking statement, TPH, BOS, Constriction, VideoRay UROVs, Death, NYSE, Respiratory tract, CA, ATS, Poster, PAH, Patient, Lung transplantation, Pulmonary hypertension, Survival, Tryptophan hydroxylase, FDA, CLAD, Degenerative disease, Serotonin, Hepatic artery proper, Heart, LinkedIn, Disease, Hypertensive emergency, Vasoconstriction, Ambrisentan, Pathology, Vasodilation, Vascular remodelling in the embryo, Multimedia, Pharmaceutical industry

Pulmonary arterial hypertension (PAH) is a rare, progressive disorder characterized by vasoconstriction, cellular proliferation, and remodeling in the small pulmonary arteries.

Key Points: 
  • Pulmonary arterial hypertension (PAH) is a rare, progressive disorder characterized by vasoconstriction, cellular proliferation, and remodeling in the small pulmonary arteries.
  • These changes lead to high pulmonary arterial pressure, right heart strain, and ultimately, right heart failure and death.
  • Altavant is currently testing this mechanism of action in ELEVATE 2, a proof-of-concept Phase 2 study of rodatristat ethyl in patients with PAH.
  • Rodatristat ethyl is a tryptophan hydroxylase (TPH) inhibitor in Phase 2 development for patients with pulmonary arterial hypertension.

ALTAVANT SCIENCES PRESENTED DATA AT ISHLT SHOWING POTENCY AND DISTRIBUTION OF BRONCHIOLITIS OBLITERANS CANDIDATE, ALTA-2530

Retrieved on: 
Monday, May 2, 2022
Lazarus, Optimism, Forward-looking statement, TPH, BOS, IL-6, VideoRay UROVs, SVP, Development, International Society for Heart and Lung Transplantation, NYSE, Respiratory tract, PAH, APG system, Patient, Fibrosis, Lung transplantation, Lung, Tryptophan hydroxylase, FDA, CLAD, Degenerative disease, Serotonin, Bronchiole, LinkedIn, Disease, Hypertensive emergency, International Society, Vascular remodelling in the embryo, Multimedia, Pharmaceutical industry, Vaccine, Research

Results of in vivo studies presented at ISHLT demonstrate that once-daily administration of aerosolized ALTA-2530 achieved distribution to the distal regions of the lung.

Key Points: 
  • Results of in vivo studies presented at ISHLT demonstrate that once-daily administration of aerosolized ALTA-2530 achieved distribution to the distal regions of the lung.
  • , Altavant's Chief Medical Officer added, "Following lung transplant, inappropriate activation of the innate immune system has been shown to drive transplant rejection.
  • ALTA-2530 is currently in preclinical development at Altavant for the treatment of BOS and chemical lung injuries.
  • Altavant Sciences is a clinical-stage biopharmaceutical company focused on elevating patient-centric drug development in rare respiratory diseases.

Biostrap Labs Study Finds Biolight Low-level Light Therapy To Reduce Stress And Improve Sleep Parameters

Retrieved on: 
Wednesday, December 8, 2021
Sleep, Research, Population, Tissue, Health, Oxidative stress, Growth, RPM, Lists of diseases, Safety, Mitochondrion, Vascular remodelling in the embryo, CEO, Industry, Data analysis, Myalgia, Physiology, Education, HRV, Heart rate, LLLT, Founder, Degenerative disease, Medical imaging

This Biostrap Labs study was able to gain such valuable insights.

Key Points: 
  • This Biostrap Labs study was able to gain such valuable insights.
  • "I am extremely excited and proud that BioLight has become the first LED panel red light therapy company to conduct scientific research and validate its products," said Dr. Mike Belkowski, CEO and Founder of BioLight.
  • Longitudinal metrics including deep sleep duration were also affected, and participants reported decreased musculoskeletal pain and training-related soreness throughout the study duration.
  • Beyond creating innovative, leading-edge red light therapy technology, BioLight provides in-depth education for the masses.